NEW YORK, Nov. 26, 2019 (GLOBE NEWSWIRE) -- BrainStorm Cell Therapeutics Inc. (NASDAQ: BCLI), a leader in the development of innovative autologous cellular therapies for highly debilitating neurodegenerative diseases, announced today that the Company is proud to be a gold sponsor of the 30th International Symposium on ALS/MND.

The symposium will take place December 4 6, 2019, at the Perth Convention and Exhibition Centre in Perth, Australia. The International Symposium on ALS/MND is a unique annual event that brings together leading international researchers and health and social care professionals to present and debate key innovations in their respective fields.

Ralph Kern MD MHSc, BrainStorms Chief Operating and Chief Medical Officer, will deliver a podium presentation: Modulation of innate immunity by MSC-NTF (NurOwn) cells correlates with ALS clinical outcomes, on December 4, from 11:50 12:10 pm AWST during the opening day Clinical Trials Session. In addition to the podium presentation, the Company will also present Poster 153: MSC-NTF Differentiation Increases the Neurotrophic Effects of MSC Cells: Live Imaging Analysis, that directly demonstrates the neuroprotective effects of NurOwn in a neuronal cell culture model.

Our fully-enrolled phase 3 clinical trial is one of the most advanced clinical programs in ALS, stated Chaim Lebovits, President and CEO of BrainStorm. He added, The International Symposium on ALS/MND is an important venue to update the community on our clinical and scientific efforts towards the advancement of therapies that may address the unmet needs of those living with ALS. BrainStorm Cell Therapeutics is proud to serve as a sponsor of this important annual symposium which underscores our commitment to the international community of ALS and MND patients, their families and their caregivers.

Ralph Kern, MD, stated, It is a privilege to present our innovative biomarker and preclinical research at the International Symposium on ALS/MND. He added, Every year, symposium participants gather together and discuss the opportunities and the challenges that we will face during the upcoming year. Research and medical breakthroughs for the ALS and MND community continue to make significant progress and we look forward to sharing our insights and engaging with colleagues from around the globe. The International Symposium on ALS/MND reminds us how far we have come in investigational therapies and how much more progress is still needed to bring patients a better and more promising future.

About NurOwn

NurOwn (autologous MSC-NTF) cells represent a promising investigational therapeutic approach to targeting disease pathways important in neurodegenerative disorders. MSC-NTF cells are produced from autologous, bone marrow-derived mesenchymal stem cells (MSCs) that have been expanded and differentiated ex vivo. MSCs are converted into MSC-NTF cells by growing them under patented conditions that induce the cells to secrete high levels of neurotrophic factors. Autologous MSC-NTF cells can effectively deliver multiple NTFs and immunomodulatory cytokines directly to the site of damage to elicit a desired biological effect and ultimately slow or stabilize disease progression. BrainStorm has fully enrolled a Phase 3 pivotal trial of autologous MSC-NTF cells for the treatment of amyotrophic lateral sclerosis (ALS). BrainStorm also received U.S. FDA acceptance to initiate a Phase 2 open-label multicenter trial in progressive MS and enrollment began in March 2019.

About BrainStorm Cell Therapeutics Inc.

BrainStorm Cell Therapeutics Inc. is a leading developer of innovative autologous adult stem cell therapeutics for debilitating neurodegenerative diseases. The Company holds the rights to clinical development and commercialization of the NurOwn technology platform used to produce autologous MSC-NTF cells through an exclusive, worldwide licensing agreement. Autologous MSC-NTF cells have received Orphan Drug status designation from the U.S. Food and Drug Administration (U.S. FDA) and the European Medicines Agency (EMA) in ALS. BrainStorm has fully enrolled a Phase 3 pivotal trial in ALS (NCT03280056), investigating repeat-administration of autologous MSC-NTF cells at six sites in the U.S., supported by a grant from the California Institute for Regenerative Medicine (CIRM CLIN2-0989). The pivotal study is intended to support a filing for U.S. FDA approval of autologous MSC-NTF cells in ALS. For more information, visit BrainStorm's website at http://www.brainstorm-cell.com.

The International Symposium on ALS/MND is a unique annual event that brings together leading international researchers and health and social care professionals to present and debate key innovations in their respective fields. The Symposium is planned as two parallel meetings, one on biomedical research and the other on advances in the care and management of people affected by ALS/MND. Joint sessions consider issues of mutual concern, challenging current views and practices.

Safe-Harbor Statements

Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may," "should," "would," "could," "will," "expect," "likely," "believe," "plan," "estimate," "predict," "potential," and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, risks associated with BrainStorm's limited operating history, history of losses; minimal working capital, dependence on its license to Ramot's technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

BRAINSTORM CONTACTS:Investors:Uri Yablonka, Chief Business OfficerBrainStorm Cell Therapeutics IncPhone: : +1-201-488-0460Email: uri@brainstorm-cell.com

Media:Sean LeousWestwicke/ICR PRPhone: +1.646.677.1839Email:sean.leous@icrinc.com

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BrainStorm Cell Therapeutics to make scientific presentations at the 30th International Symposium on ALS/MND - GlobeNewswire

Bone Marrow Stem Cells Comments Off on BrainStorm Cell Therapeutics to make scientific presentations at the 30th International Symposium on ALS/MND – GlobeNewswire | November 26th, 2019

Stem Cell Banking Market Report 2018-2026includes a comprehensive analysis of the present Market. The report starts with the basic Stem Cell Banking industry overview and then goes into each and every detail.

Stem Cell Banking Market Report contains in depth information major manufacturers, opportunities, challenges, and industry trends and their impact on the market forecast. Stem Cell Banking also provides data about the company and its operations. This report also provides information on the Pricing Strategy, Brand Strategy, Target Client, Distributors/Traders List offered by the company.

Description:

High potential of cord blood and tissues for the treatment of patients with autoimmune diseases is expected to propel the market growth. Moreover, currently available immunosuppressive agents such as steroids, induce long term side effects despite temporary improvements. According to the Health Research Funding, 2015, around 28% of cord blood transplants have been used to treat genetic diseases, with the most common genetic disease treated being severe combined immune deficiency, followed by aplastic anemia. According to the National Cord Blood Program, 2015, cord blood from unrelated donors has been used as an alternative to bone marrow or mobilized stem cells, as a source of hematopoietic stem cells, with over 35,000 stem cell transplants successfully performed worldwide.

Stem Cell Banking Market competition by top manufacturers/players, with Stem Cell Banking sales volume, Price (USD/Unit), Revenue (Million USD) and Market Share for each manufacturer/player; the top players including: Allergan, Plc., Galderma S.A., Integra LifeSciences Corporation, Merz Pharma GmbH & Co. KGaA., Sanofi S.A., SciVision Biotech Inc., Sinclair Pharma Plc., Suneva Medical, Valeant Pharmaceuticals International, Inc., and Anika Therapeutics, Inc.

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Important Features that are under offer & key highlights of the report:

What all regional segmentation covered? Can the specific country of interest be added?Currently, the research report gives special attention and focus on the following regions:North America (U.S., Canada, Mexico), Europe (Germany, U.K., France, Italy, Russia, Spain etc), South America (Brazil, Argentina etc) & Middle East & Africa (Saudi Arabia, South Africa etc)** One country of specific interest can be included at no added cost. For inclusion of more regional segment quote may vary.

What all companies are currently profiled in the report?The report Contain the Major Key Players currently profiled in this market.** List of companies mentioned may vary in the final report subject to Name Change / Merger etc.

Can we add or profiled new company as per our need?Yes, we can add or profile new company as per client need in the report. Final confirmation to be provided by the research team depending upon the difficulty of the survey.** Data availability will be confirmed by research in case of a privately held company. Up to 3 players can be added at no added cost.

Can the inclusion of additional Segmentation / Market breakdown is possible?Yes, the inclusion of additional segmentation / Market breakdown is possible to subject to data availability and difficulty of the survey. However, a detailed requirement needs to be shared with our research before giving final confirmation to the client.** Depending upon the requirement the deliverable time and quote will vary.

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Stem Cell Banking Market Dynamics in the world mainly, the worldwide 2018-2026 Stem Cell Banking Market is analyzed across major global regions. CMI also provides customized specific regional and country-level reports for the following areas:

Region Segmentation:

North America (USA, Canada and Mexico)Europe (Germany, France, UK, Russia and Italy)Asia-Pacific (China, Japan, Korea, India and Southeast Asia)South America (Brazil, Argentina, Columbia etc.)Middle East and Africa (Saudi Arabia, UAE, Egypt, Nigeria and South Africa)

Further in the report, the Stem Cell Banking market is examined for Sales, Revenue, Price and Gross Margin. These points are analyzed for companies, types, and regions. In continuation with this data, the sale price is for various types, applications and region is also included. The Stem Cell Banking industry consumption for major regions is given. Additionally, type wise and application wise figures are also provided in this report.

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In this study, the years considered to estimate the market size of 2018-2026 Stem Cell Banking Market are as follows:History Year: 2015-2017Base Year: 2017Estimated Year: 2018Forecast Year 2018 to 2026

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Stem Cell Banking Market to Expand Steadily in the Coming Years till 2018-2026 - Crypto Journal

Bone Marrow Stem Cells Comments Off on Stem Cell Banking Market to Expand Steadily in the Coming Years till 2018-2026 – Crypto Journal | November 26th, 2019

Former Humbolt Broncos player Ryan Straschnitzki. Doctors implanted an epidural stimulator in Straschnitzkis spine earlier this month and a week later injected stem cells above and below the injury in the hope that will help reverse some of the damage.

Todd Korol/The Canadian Press

The mother of a hockey player paralyzed in the Humboldt Broncos bus crash says shes stunned by the progress he has made since receiving spinal surgery in Thailand.

Doctors implanted an epidural stimulator in Ryan Straschnitzkis spine earlier this month and a week later injected stem cells above and below the injury in the hope that will help reverse some of the damage.

The 20-year-old from Airdrie, Alta., is to remain in Thailand until early December.

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Hands down Im 200-per-cent behind this. I didnt expect this kind of result this quickly, Michelle Straschnitzki said in an interview. Its definitely not a quick fix. Its not a cure, but its certainly progress and its more than weve had in 19 months.

Tom Straschnitzki, who is also in Thailand, has posted a number of videos of his sons rehab, including one where the young man was able to move a leg. Another video shows him strapped into a harness as physiotherapists slowly help him walk with the use of a machine on wheels.

Bout time he got off his ass. 1st time since he boarded the bus that horrendous day, Straschnitzki tweeted.

Therapist helping with knees and ankles so they dont buckle. Ryan did so good, I sent him to the beer store for me.

Ryan Straschnitzki was one of 13 players who were injured when an inexperienced truck driver blew through a stop sign and into the path of the Saskatchewan junior hockey teams bus in April, 2018. Sixteen others on the bus died.

Straschnitzki, who was paralyzed from the chest down, has said he isnt expecting a cure, but hopes the implant will restore some muscle movement and things such as bladder control.

A small device like a remote control is to send electrical currents to his spinal cord to try to stimulate nerves and move limbs. The implant is being programmed to stimulate certain nerves mapped out by surgeons and therapists.

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The surgery can cost up to $100,000 and isnt covered by public health care or insurance, because the epidural procedure has not been approved by Health Canada. The family is paying for it themselves. It is also performed in countries such as the United States and Switzerland, but it is much cheaper in Thailand.

The players mother, who didnt go to Thailand, said hes been low key when shes talked to him.

In typical Ryan fashion hes very quiet. All he says is hes very tired and you can tell. His body, his mind, everything is tired because hes pushing as far as he can.

Her son takes part in nerve mapping in the morning, does physio in the afternoon and then does more work with the implant, she said. He still plans to hit the ice in Bangkok with his hockey sledge before returning home.

Straschnitzki said seeing her boys progress on the videos stunned her.

I was just absolutely floored. It obviously brought the tears. I was bawling. It was unreal, she said.

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Tom said the last time Ryan walked was when he walked on the bus and then, to watch him moving his legs, walking essentially, that just rocked me.

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A sledge hockey team made up of talented Tier 1 players will be wearing Calgary Flames jerseys when they hit the ice at the upcoming 2019 USA Hockey Sled Classic which will be presented by the NHL in St. Louis next month. The Canadian Press

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'I was bawling': Mother of former Humboldt Broncos player says she's stunned by his progress after surgery - The Globe and Mail

Spinal Cord Stem Cells Comments Off on ‘I was bawling’: Mother of former Humboldt Broncos player says she’s stunned by his progress after surgery – The Globe and Mail | November 26th, 2019

BEDFORD, Mass., Nov. 26, 2019 (GLOBE NEWSWIRE) -- Homology Medicines, Inc. (Nasdaq: FIXX), a genetic medicines company, announced today a peer-reviewed publication demonstrating its proprietary adeno-associated viral vectors (AAVHSCs) crossed the blood-brain-barrier and blood-nerve-barrier in non-human primates (NHPs), highlighting their potential to deliver gene therapy for central and peripheral nervous system disorders.

The publication includes the initial characterization of biodistribution with three of Homologys 15 AAVHSCs, including their ability to transduce, or target, key cells following a single intravenous (I.V.) administration in NHPs. AAVHSCs are naturally occurring vectors originally isolated from human hematopoietic stem cells.

Many neurological diseases, including lysosomal storage and neuromuscular disorders, have cognitive and systemic components requiring a genetic medicine to reach multiple tissues to target the disease-relevant cell types, said Albert Seymour, Ph.D., Chief Scientific Officer of Homology Medicines. Here we evaluated the ability of three of our novel AAVHSCs to cross the blood-brain-barrier and the blood-nerve barrier after I.V. administration in NHPs in addition to other key tissues, which allows us to choose the vectors best suited for particular diseases. We have observed that small sequence changes among our family of AAVHSCs are associated with differences in their ability to target disease-relevant tissues. We continue to characterize these properties and the potential of AAVHSCs as vehicles for therapeutic delivery.

Following I.V. administration of AAVHSC -7, -15 and -17 in NHPs, analyses showed transduction and transgene expression:

The publication, Clade F AAVHSCs Cross the Blood Brain Barrier and Transduce the Central Nervous System in Addition to Peripheral Tissues Following Intravenous Administration in Nonhuman Primates, was peer-reviewed and published in the journal PLOS ONE. For more information, please visithttps://journals.plos.org/plosone/article?id=10.1371/journal.pone.0225582or http://www.homologymedicines.com/publications.

About Homology Medicines, Inc. Homology Medicines, Inc. is a genetic medicines company dedicated to transforming the lives of patients suffering from rare genetic diseases with significant unmet medical needs by curing the underlying cause of the disease. Homologys proprietary platform is designed to utilize its human hematopoietic stem cell-derived adeno-associated virus vectors (AAVHSCs) to precisely and efficiently deliver genetic medicinesin vivoeither through a gene therapy or nuclease-free gene editing modality across a broad range of genetic disorders. Homology has a management team with a successful track record of discovering, developing and commercializing therapeutics with a particular focus on rare diseases, and intellectual property covering its suite of 15 AAVHSCs. Homology believes that its compelling preclinical data, scientific expertise, product development strategy, manufacturing capabilities and intellectual property position it as a leader in the development of genetic medicines. For more information, please visitwww.homologymedicines.com.

Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding our expectations surrounding the potential, safety, efficacy, and regulatory and clinical progress of our product candidates; beliefs about preclinical data and the properties and potential of our AAVHSCs; and our position as a leader in the development of genetic medicines. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we have and expect to continue to incur significant losses; our need for additional funding, which may not be available; failure to identify additional product candidates and develop or commercialize marketable products; the early stage of our development efforts; potential unforeseen events during clinical trials could cause delays or other adverse consequences; risks relating to the capabilities and potential expansion of our manufacturing facility; risks relating to the regulatory approval process; our product candidates may cause serious adverse side effects; inability to maintain our collaborations, or the failure of these collaborations; our reliance on third parties; failure to obtain U.S. or international marketing approval; ongoing regulatory obligations; effects of significant competition; unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives; product liability lawsuits; failure to attract, retain and motivate qualified personnel; the possibility of system failures or security breaches; risks relating to intellectual property and significant costs as a result of operating as a public company. These and other important factors discussed under the caption Risk Factors in our Quarterly Report on Form 10-Q for the quarter endedSeptember 30, 2019and our other filings with theSECcould cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent managements estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.

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Homology Medicines Announces Peer-Reviewed Publication Demonstrating its AAVHSC Vectors Crossed the Blood-Brain-Barrier and Blood-Nerve-Barrier in...

Spinal Cord Stem Cells Comments Off on Homology Medicines Announces Peer-Reviewed Publication Demonstrating its AAVHSC Vectors Crossed the Blood-Brain-Barrier and Blood-Nerve-Barrier in… | November 26th, 2019

Medically reviewed by Richard M. Stone, MD

More than 60,000 new cases ofadult leukemiaare diagnosed in the U.S. each year. Although it is one of the more common childhood cancers,leukemia occurs more often in older adults.

Leukemia is a cancer of the bodys blood-forming tissues that results in large numbers of abnormal or immature white blood cells. The main types of leukemia are:

AML causes the bone marrow to produce immature white blood cells (called myeloblasts). As a result, patients may have a very high or lowwhite blood cellcount, and lowred blood cellsandplatelets.

CLL is the second most common type of leukemia in adults. It is a type of cancer in which the bone marrow makes too many maturelymphocytes(a type of white blood cell).

ALL is a type of leukemia in which the bone marrow makes too many immaturelymphocytes. Similar to AML, the white blood cells can be high or low and oftentimes the platelets and red blood cells are low. This form of leukemia is more common in children than adults.

CML is usually a slowly progressing disease in which too many mature white blood cells are made in the bone marrow.

People with leukemia may experience:

Because these symptoms can be caused by a variety of other conditions, its important to check with your doctor if they arise.

While studies have shown men to be more atrisk than women, some other risk factors include:

While test procedures vary based on the type of leukemia, the two most common procedures are thecomplete blood count(CBC) test and the bone marrow aspiration biopsy.

CBC is a procedure used to check the redblood cell and platelet counts as well as the number and type of white bloodcells (the red cells carry oxygen, the white cells fight and prevent infection,and platelets control bleeding). A bone marrow aspiration biopsy involvesremoving a sample of bone marrow, including a small piece of bone by insertinga needle into the hipbone. The sample is then examined for abnormal cells.

Treatment for leukemia varies depending on the type and specific diagnosis.

The treatment for acute leukemias may be lengthy up to two years in ALL and is usually done in phases. The first phase, known as remission induction therapy, involves administering several chemotherapy drugs over a several-week period. The goal is to destroy as many cancer cells as possible to achieve a remission (in which cancer cells are undetectable, but small amounts are still present).

The second phase, known aspost-remission or consolidation therapy, seeks to kill leukemia cells thatremain after remission induction therapy. This phase may involve chemotherapyand/or a stem cell transplant.

Additional treatments may also be necessary. ALL patients, for example, may receive special treatment to prevent the disease from recurring in the spinal cord or brain.

The treatment for CML has been revolutionized by the advent of the oral medication imatinib and the second- and third-generation drugs known as tyrosine kinase inhibitors (TKIs). These are oral medications that work to inhibit the function of theBCR-ABLprotein. Many patients take these medications for the rest of their lives. In rare instances, a patient may require a stem cell transplant.

Some patients with CLL are recommended formonitoring and observation. Others,usually those with symptoms or low red cell or platelet counts, requiretreatment. Such treatment may involve intravenous chemotherapy, but often withoral therapy with pills that inhibit the function of a key protein, Brutonstyrosine kinase.

Treatments for leukemia can include:

Drugs that harness the immune system in fighting leukemia have shown considerable promise. Some monoclonal antibodies synthetic versions of immune system proteins are already in use to treat certain forms of leukemia and others are being studies in clinical trials.

Another form of immunotherapy, immune checkpoint inhibitors, which release a pent-up immune system attack on tumor cells, is being tested in several forms of leukemia. Cancer vaccines, which boost the immune systems ability to fight cancer, are being studied for use in leukemia.

CAR T-cell therapy, which uses modified immune system T cells to better target and kill tumor cells, has achieved impressive results in trials involving children and adults up to age 25 with relapsed ALL.

Research into new treatments for adult leukemia is moving along several tracks in addition to immunotherapy.

By tracking the specific abnormal genes within leukemia cells, physicians are increasingly able to tailor treatment to the unique characteristics of the disease in each patient. Targeted drugs such as imatinib and dasatinib, for example, are now used in treating patients with ALL whose leukemia cells have an abnormality known as the Philadelphia chromosome. Targeted agents including IDH or FLT3 inhibitors, which zero in on proteins made from mutated genes, have been approved to treat some patients with AML, while other such inhibitors are being tested in clinical trials.

New tests make it possible to detect ever smaller amounts of leukemia that remain after treatment. Investigators are exploring how these minute levels may influence a patients prognosis and how they might impact treatment.

Researchers are testing whether treatment periods for certain drugs can be safely reduced in some patients. For instance, studies are under way to determine if drugs such as imatinib, which are currently taken for life, can be safely stopped in some patients with CML. Researchers hope to test whether treating patients with CLL with the drug ibrutinib plus other medicine for a fixed amount of time is safe and effective.

Patients may consider treatment through a clinical trial.Dana-Farber currently has more than 30 clinical trials for adult leukemia. A national list of clinical trials is available atclinicaltrials.gov.

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Adult Leukemia: What You Need to Know - Dana-Farber Cancer Institute

Spinal Cord Stem Cells Comments Off on Adult Leukemia: What You Need to Know – Dana-Farber Cancer Institute | November 26th, 2019

KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that KEYTRUDA, Mercks anti-PD-1 therapy, has been approved by the National Medical Products Administration (NMPA) in China in combination with carboplatin and paclitaxel for the first-line treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC). This new indication was granted full approval based on overall survival (OS) findings from the pivotal Phase 3 KEYNOTE-407 trial, including interim data from an extension of the global study in Chinese patients. With this third first-line approval in NSCLC in less than one year, KEYTRUDA is now the first anti-PD-1 therapy approved in China in combination with chemotherapy for the first-line treatment of squamous and nonsquamous NSCLC, as well as in the monotherapy setting for appropriate patients with NSCLC (tumor proportion score [TPS] 1%).

In KEYNOTE-407, KEYTRUDA in combination with chemotherapy significantly improved both overall survival and progression-free survival in patients with metastatic squamous non-small cell lung cancer, said Prof. Ying Cheng, director of Jilin Cancer Hospital. Lung cancer is the leading cause of cancer death in China, so this approval represents an important milestone for the patients and families facing this difficult-to-treat disease.

In KEYNOTE-407, data from a pre-specified interim analysis showed that KEYTRUDA in combination with chemotherapy (carboplatin and either paclitaxel or nab-paclitaxel) resulted in a statistically significant improvement in OS and progression-free survival (PFS), the dual primary endpoints, compared to chemotherapy alone. Specifically, KEYTRUDA in combination with chemotherapy reduced the risk of death by 36% compared to chemotherapy alone (HR=0.64 [95% CI, 0.49-0.85]; p=0.0017). KEYTRUDA in combination with chemotherapy also demonstrated an improvement in PFS, with a reduction in the risk of progression or death by 44% compared to chemotherapy alone (HR=0.56 [95% CI, 0.45-0.70]; p<0.0001). In the extension of the global study in Chinese patients, KEYTRUDA in combination with chemotherapy reduced the risk of death by 56% compared to chemotherapy alone (HR=0.44 [95% CI, 0.24-0.81]). The China extension study also demonstrated an improvement in PFS, with a reduction in the risk of progression or death by 68% compared to chemotherapy alone (HR=0.32 [95% CI, 0.21-0.49]). Additional findings from the KEYNOTE-407 China extension study were recently presented at the European Society for Medical Oncology (ESMO) Asia 2019 Congress.

This approval expands our current lung cancer indications in China to include KEYTRUDA in combination with chemotherapy in patients with squamous cell carcinoma, a particularly difficult-to-treat type of lung cancer, said Dr. Jonathan Cheng, vice president, oncology clinical research, Merck Research Laboratories. Importantly, KEYTRUDA provides a foundation for the treatment of lung cancer in China and now more patients with non-small cell lung cancer may have the opportunity to benefit from combination therapy with KEYTRUDA.

In less than one year, we have received three first-line approvals for KEYTRUDA, in combination with chemotherapy or as monotherapy, in non-small cell lung cancer, said Joseph Romanelli, president of MSD in China. KEYTRUDA, in combination with chemotherapy or as monotherapy, has demonstrated a significant survival benefit versus chemotherapy and we will continue to work closely with the external stakeholders to bring this important treatment option to patients.

About Lung Cancer in China

Lung cancer, which forms in the tissues of the lungs, usually within cells lining the air passages, is the leading cause of cancer death in China and worldwide. Each year, more than 787,000 new cases of lung cancer are diagnosed in China and more than 631,000 deaths result from the disease. The two main types of lung cancer are non-small cell and small cell. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for about 85% of all cases. There are several subtypes of NSCLC, including adenocarcinoma (accounting for 40% of lung cancers), squamous cell carcinoma (25 to 30%) and large cell carcinoma (10 to 15%).

About KEYTRUDA (pembrolizumab) Injection

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,000 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patients likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected Indications for KEYTRUDA (pembrolizumab) in the U.S.

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic HNSCC with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for the treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [CPS 10] as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Microsatellite Instability-High (MSI-H) Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grade 3-5 in 1.5% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)

Immune-Mediated Hepatitis

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hepatotoxicity in Combination With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.

Immune-Mediated Endocrinopathies

KEYTRUDA can cause hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%), receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.

Monitor patients for signs and symptoms of hypophysitis (including hypopituitarism and adrenal insufficiency), thyroid function (prior to and periodically during treatment), and hyperglycemia. For hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 and withhold or discontinue for Grade 3 or 4 hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.

Immune-Mediated Skin Reactions

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barr syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including cHL, and postmarketing use.

Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients.

Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic HSCT after treatment with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after KEYTRUDA, 6 (26%) developed graft-versus-host disease (GVHD) (1 fatal case) and 2 (9%) developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning (1 fatal case). Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptorblocking antibody before transplantation. Follow patients closely for early evidence of transplant-related complications such as hyperacute graft-versus-host disease (GVHD), Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease (VOD), and other immune-mediated adverse reactions.

In patients with a history of allogeneic HSCT, acute GVHD (including fatal GVHD) has been reported after treatment with KEYTRUDA. Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after KEYTRUDA. Consider the benefit of KEYTRUDA vs the risk of GVHD in these patients.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with a PD-1 or PD-L1 blocking antibody in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman. Advise women of this potential risk. In females of reproductive potential, verify pregnancy status prior to initiating KEYTRUDA and advise them to use effective contraception during treatment and for 4 months after the last dose.

Adverse Reactions

In KEYNOTE-006, KEYTRUDA was discontinued due to adverse reactions in 9% of 555 patients with advanced melanoma; adverse reactions leading to permanent discontinuation in more than one patient were colitis (1.4%), autoimmune hepatitis (0.7%), allergic reaction (0.4%), polyneuropathy (0.4%), and cardiac failure (0.4%). The most common adverse reactions (20%) with KEYTRUDA were fatigue (28%), diarrhea (26%), rash (24%), and nausea (21%).

In KEYNOTE-054, KEYTRUDA was permanently discontinued due to adverse reactions in 14% of 509 patients; the most common (1%) were pneumonitis (1.4%), colitis (1.2%), and diarrhea (1%). Serious adverse reactions occurred in 25% of patients receiving KEYTRUDA. The most common adverse reaction (20%) with KEYTRUDA was diarrhea (28%).

In KEYNOTE-189, when KEYTRUDA was administered with pemetrexed and platinum chemotherapy in metastatic nonsquamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 20% of 405 patients. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonitis (3%) and acute kidney injury (2%). The most common adverse reactions (20%) with KEYTRUDA were nausea (56%), fatigue (56%), constipation (35%), diarrhea (31%), decreased appetite (28%), rash (25%), vomiting (24%), cough (21%), dyspnea (21%), and pyrexia (20%).

In KEYNOTE-407, when KEYTRUDA was administered with carboplatin and either paclitaxel or paclitaxel protein-bound in metastatic squamous NSCLC, KEYTRUDA was discontinued due to adverse reactions in 15% of 101 patients. The most frequent serious adverse reactions reported in at least 2% of patients were febrile neutropenia, pneumonia, and urinary tract infection. Adverse reactions observed in KEYNOTE-407 were similar to those observed in KEYNOTE-189 with the exception that increased incidences of alopecia (47% vs 36%) and peripheral neuropathy (31% vs 25%) were observed in the KEYTRUDA and chemotherapy arm compared to the placebo and chemotherapy arm in KEYNOTE-407.

In KEYNOTE-042, KEYTRUDA was discontinued due to adverse reactions in 19% of 636 patients; the most common were pneumonitis (3%), death due to unknown cause (1.6%), and pneumonia (1.4%). The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia (7%), pneumonitis (3.9%), pulmonary embolism (2.4%), and pleural effusion (2.2%). The most common adverse reaction (20%) was fatigue (25%).

In KEYNOTE-010, KEYTRUDA monotherapy was discontinued due to adverse reactions in 8% of 682 patients with metastatic NSCLC; the most common was pneumonitis (1.8%). The most common adverse reactions (20%) were decreased appetite (25%), fatigue (25%), dyspnea (23%), and nausea (20%).

Adverse reactions occurring in patients with SCLC were similar to those occurring in patients with other solid tumors who received KEYTRUDA as a single agent.

In KEYNOTE-048, KEYTRUDA monotherapy was discontinued due to adverse events in 12% of 300 patients with HNSCC; the most common adverse reactions leading to permanent discontinuation were sepsis (1.7%) and pneumonia (1.3%). The most common adverse reactions (20%) were fatigue (33%), constipation (20%), and rash (20%).

In KEYNOTE-048, when KEYTRUDA was administered in combination with platinum (cisplatin or carboplatin) and FU chemotherapy, KEYTRUDA was discontinued due to adverse reactions in 16% of 276 patients with HNSCC. The most common adverse reactions resulting in permanent discontinuation of KEYTRUDA were pneumonia (2.5%), pneumonitis (1.8%), and septic shock (1.4%). The most common adverse reactions (20%) were nausea (51%), fatigue (49%), constipation (37%), vomiting (32%), mucosal inflammation (31%), diarrhea (29%), decreased appetite (29%), stomatitis (26%), and cough (22%).

In KEYNOTE-012, KEYTRUDA was discontinued due to adverse reactions in 17% of 192 patients with HNSCC. Serious adverse reactions occurred in 45% of patients. The most frequent serious adverse reactions reported in at least 2% of patients were pneumonia, dyspnea, confusional state, vomiting, pleural effusion, and respiratory failure. The most common adverse reactions (20%) were fatigue, decreased appetite, and dyspnea. Adverse reactions occurring in patients with HNSCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of facial edema and new or worsening hypothyroidism.

In KEYNOTE-087, KEYTRUDA was discontinued due to adverse reactions in 5% of 210 patients with cHL. Serious adverse reactions occurred in 16% of patients; those 1% included pneumonia, pneumonitis, pyrexia, dyspnea, GVHD, and herpes zoster. Two patients died from causes other than disease progression; 1 from GVHD after subsequent allogeneic HSCT and 1 from septic shock. The most common adverse reactions (20%) were fatigue (26%), pyrexia (24%), cough (24%), musculoskeletal pain (21%), diarrhea (20%), and rash (20%).

In KEYNOTE-170, KEYTRUDA was discontinued due to adverse reactions in 8% of 53 patients with PMBCL. Serious adverse reactions occurred in 26% of patients and included arrhythmia (4%), cardiac tamponade (2%), myocardial infarction (2%), pericardial effusion (2%), and pericarditis (2%). Six (11%) patients died within 30 days of start of treatment. The most common adverse reactions (20%) were musculoskeletal pain (30%), upper respiratory tract infection and pyrexia (28% each), cough (26%), fatigue (23%), and dyspnea (21%).

In KEYNOTE-052, KEYTRUDA was discontinued due to adverse reactions in 11% of 370 patients with locally advanced or metastatic urothelial carcinoma. Serious adverse reactions occurred in 42% of patients; those 2% were urinary tract infection, hematuria, acute kidney injury, pneumonia, and urosepsis. The most common adverse reactions (20%) were fatigue (38%), musculoskeletal pain (24%), decreased appetite (22%), constipation (21%), rash (21%), and diarrhea (20%).

In KEYNOTE-045, KEYTRUDA was discontinued due to adverse reactions in 8% of 266 patients with locally advanced or metastatic urothelial carcinoma. The most common adverse reaction resulting in permanent discontinuation of KEYTRUDA was pneumonitis (1.9%). Serious adverse reactions occurred in 39% of KEYTRUDA-treated patients; those 2% were urinary tract infection, pneumonia, anemia, and pneumonitis. The most common adverse reactions (20%) in patients who received KEYTRUDA were fatigue (38%), musculoskeletal pain (32%), pruritus (23%), decreased appetite (21%), nausea (21%), and rash (20%).

Adverse reactions occurring in patients with gastric cancer were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

Adverse reactions occurring in patients with esophageal cancer were similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy.

In KEYNOTE-158, KEYTRUDA was discontinued due to adverse reactions in 8% of 98 patients with recurrent or metastatic cervical cancer. Serious adverse reactions occurred in 39% of patients receiving KEYTRUDA; the most frequent included anemia (7%), fistula, hemorrhage, and infections [except urinary tract infections] (4.1% each). The most common adverse reactions (20%) were fatigue (43%), musculoskeletal pain (27%), diarrhea (23%), pain and abdominal pain (22% each), and decreased appetite (21%).

Adverse reactions occurring in patients with HCC were generally similar to those in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy, with the exception of increased incidences of ascites (8% Grades 3-4) and immune-mediated hepatitis (2.9%). Laboratory abnormalities (Grades 3-4) that occurred at a higher incidence were elevated AST (20%), ALT (9%), and hyperbilirubinemia (10%).

Among the 50 patients with MCC enrolled in study KEYNOTE-017, adverse reactions occurring in patients with MCC were generally similar to those occurring in patients with melanoma or NSCLC who received KEYTRUDA as a monotherapy. Laboratory abnormalities (Grades 3-4) that occurred at a higher incidence were elevated AST (11%) and hyperglycemia (19%).

In KEYNOTE-426, when KEYTRUDA was administered in combination with axitinib, fatal adverse reactions occurred in 3.3% of 429 patients. Serious adverse reactions occurred in 40% of patients, the most frequent of which (1%) included hepatotoxicity (7%), diarrhea (4.2%), acute kidney injury (2.3%), dehydration (1%), and pneumonitis (1%). Permanent discontinuation due to an adverse reaction occurred in 31% of patients; KEYTRUDA only (13%), axitinib only (13%), and the combination (8%). The most common adverse reactions (>1%) resulting in permanent discontinuation of KEYTRUDA, axitinib or the combination were hepatotoxicity (13%), diarrhea/colitis (1.9%), acute kidney injury (1.6%), and cerebrovascular accident (1.2%). When KEYTRUDA was used in combination with axitinib, the most common adverse reactions (20%) were diarrhea (56%), fatigue/asthenia (52%), hypertension (48%), hepatotoxicity (39%), hypothyroidism (35%), decreased appetite (30%), palmar-plantar erythrodysesthesia (28%), nausea (28%), stomatitis/mucosal inflammation (27%), dysphonia (25%), rash (25%), cough (21%), and constipation (21%).

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Merck's KEYTRUDA (pembrolizumab) Now Approved in China for First-Line Treatment of Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC) in...

Cardiac Stem Cells Comments Off on Merck’s KEYTRUDA (pembrolizumab) Now Approved in China for First-Line Treatment of Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC) in… | November 26th, 2019

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Stem Cell Therapy Market: Snapshot

Of late, there has been an increasing awareness regarding the therapeutic potential of stem cells for management of diseases which is boosting the growth of the stem cell therapy market. The development of advanced genome based cell analysis techniques, identification of new stem cell lines, increasing investments in research and development as well as infrastructure development for the processing and banking of stem cell are encouraging the growth of the global stem cell therapy market.

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One of the key factors boosting the growth of this market is the limitations of traditional organ transplantation such as the risk of infection, rejection, and immunosuppression risk. Another drawback of conventional organ transplantation is that doctors have to depend on organ donors completely. All these issues can be eliminated, by the application of stem cell therapy. Another factor which is helping the growth in this market is the growing pipeline and development of drugs for emerging applications. Increased research studies aiming to widen the scope of stem cell will also fuel the growth of the market. Scientists are constantly engaged in trying to find out novel methods for creating human stem cells in response to the growing demand for stem cell production to be used for disease management.

It is estimated that the dermatology application will contribute significantly the growth of the global stem cell therapy market. This is because stem cell therapy can help decrease the after effects of general treatments for burns such as infections, scars, and adhesion. The increasing number of patients suffering from diabetes and growing cases of trauma surgery will fuel the adoption of stem cell therapy in the dermatology segment.

Global Stem Cell Therapy Market: Overview

Also called regenerative medicine, stem cell therapy encourages the reparative response of damaged, diseased, or dysfunctional tissue via the use of stem cells and their derivatives. Replacing the practice of organ transplantations, stem cell therapies have eliminated the dependence on availability of donors. Bone marrow transplant is perhaps the most commonly employed stem cell therapy.

Osteoarthritis, cerebral palsy, heart failure, multiple sclerosis and even hearing loss could be treated using stem cell therapies. Doctors have successfully performed stem cell transplants that significantly aid patients fight cancers such as leukemia and other blood-related diseases.

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Global Stem Cell Therapy Market: Key Trends

The key factors influencing the growth of the global stem cell therapy market are increasing funds in the development of new stem lines, the advent of advanced genomic procedures used in stem cell analysis, and greater emphasis on human embryonic stem cells. As the traditional organ transplantations are associated with limitations such as infection, rejection, and immunosuppression along with high reliance on organ donors, the demand for stem cell therapy is likely to soar. The growing deployment of stem cells in the treatment of wounds and damaged skin, scarring, and grafts is another prominent catalyst of the market.

On the contrary, inadequate infrastructural facilities coupled with ethical issues related to embryonic stem cells might impede the growth of the market. However, the ongoing research for the manipulation of stem cells from cord blood cells, bone marrow, and skin for the treatment of ailments including cardiovascular and diabetes will open up new doors for the advancement of the market.

Global Stem Cell Therapy Market: Market Potential

A number of new studies, research projects, and development of novel therapies have come forth in the global market for stem cell therapy. Several of these treatments are in the pipeline, while many others have received approvals by regulatory bodies.

In March 2017, Belgian biotech company TiGenix announced that its cardiac stem cell therapy, AlloCSC-01 has successfully reached its phase I/II with positive results. Subsequently, it has been approved by the U.S. FDA. If this therapy is well- received by the market, nearly 1.9 million AMI patients could be treated through this stem cell therapy.

Another significant development is the granting of a patent to Israel-based Kadimastem Ltd. for its novel stem-cell based technology to be used in the treatment of multiple sclerosis (MS) and other similar conditions of the nervous system. The companys technology used for producing supporting cells in the central nervous system, taken from human stem cells such as myelin-producing cells is also covered in the patent.

Global Stem Cell Therapy Market: Regional Outlook

The global market for stem cell therapy can be segmented into Asia Pacific, North America, Latin America, Europe, and the Middle East and Africa. North America emerged as the leading regional market, triggered by the rising incidence of chronic health conditions and government support. Europe also displays significant growth potential, as the benefits of this therapy are increasingly acknowledged.

Asia Pacific is slated for maximum growth, thanks to the massive patient pool, bulk of investments in stem cell therapy projects, and the increasing recognition of growth opportunities in countries such as China, Japan, and India by the leading market players.

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Global Stem Cell Therapy Market: Competitive Analysis

Several firms are adopting strategies such as mergers and acquisitions, collaborations, and partnerships, apart from product development with a view to attain a strong foothold in the global market for stem cell therapy.

Some of the major companies operating in the global market for stem cell therapy are RTI Surgical, Inc., MEDIPOST Co., Ltd., Osiris Therapeutics, Inc., NuVasive, Inc., Pharmicell Co., Ltd., Anterogen Co., Ltd., JCR Pharmaceuticals Co., Ltd., and Holostem Terapie Avanzate S.r.l.

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Stem Cell Therapy Market Segmentation, Assessment and Growth Opportunities by Forecast 2025 - Tech Admirers

Cardiac Stem Cells Comments Off on Stem Cell Therapy Market Segmentation, Assessment and Growth Opportunities by Forecast 2025 – Tech Admirers | November 26th, 2019

Cardiol Therapeutics Inc. is pleased to announce the formation of the Clinical Steering Committee for a Phase 2 international trial.

Cardiol Therapeutics Inc. (TSX:CRDL, OTCQX:CRTPF) (Cardiol or the Company), a leader in the production of pharmaceutical cannabidiol (CBD) products and in the development of innovative cannabidiol medicines for heart disease, is pleased to announce the formation of the Clinical Steering Committee (CSC) for a Phase 2 international trial in acute myocarditis using the Companys CardiolRx100 cannabidiol formulation.

The CSC, which comprises key opinion leaders in acute myocarditis from North America and Europe, recently met during the American Heart Associations Scientific Sessions in Philadelphia held November 16thto 18th. The role of the CSC is to advise on the trial design, provide overall supervision of the trial, and ensure that it is being conducted in accordance with the principles of Good Clinical Practice. The CSC has oversight of the protocol, any protocol amendments, and provides advice to the investigators on all aspects of the trial.

Acute myocarditis is characterized by inflammation of the heart muscle (myocardium). The most common cause is viral infection of the heart tissue which is initially responsible for the inflammation. In a significant number of cases, perhaps due to an autoimmune process, the inflammation persists with ongoing myocardial damage and depressed heart function. Although the symptoms are often mild, myocarditis remains an important cause of acute and fulminant heart failure and is the most common cause of sudden cardiac death in people less than 35 years old. In addition, some patients proceed to develop chronic dilated cardiomyopathy which continues to be the leading indication for cardiac transplantation. Symptoms include chest pain, fatigue, shortness of breath, and arrhythmias. Because of the progressive damage to heart cells, heart failure develops (defined as the inability of the heart to pump sufficient blood to meet the needs of the body). The study will use left ventricular ejection fraction (LVEF) as one measure of heart function.

CardiolRx100 is Cardiol Therapeutics pure pharmaceutically (cGMP) produced high concentration cannabidiol formulation that is THC free (<10ppm). Based on the large body of experimental evidence of the anti-inflammatory and cardioprotective properties of cannabidiol in models of cardiovascular disease, Cardiol believes there is an opportunity to develop a potential breakthrough therapy for acute myocarditis that would be eligible for designation as an orphan drug. In the United States, an orphan drug designation is granted for pharmaceuticals being developed to treat medical conditions affecting fewer than 200,000 people. These conditions are referred to as orphan diseases. In the U.S. and the European Union, orphan drugs are eligible for accelerated marketing approvals and companies developing orphan drugs typically receive other incentives, including a prolonged period of market exclusivity that can extend over seven years, during which the drug developer has sole rights to market the drug.

Cardiol has assembled eight highly distinguished thought leaders in cardiology from North America and Europe to oversee and guide our acute myocarditis trial that is being planned at world leading heart institutes, including the Cleveland Clinic, the Mayo Clinic, the Houston Methodist DeBakey Heart and Vascular Center, the University of Ottawa Heart Institute, and Charit University Medicine Berlin, stated David Elsley, President and CEO of Cardiol Therapeutics. The U.S. orphan drug program was successfully utilized to accelerate the first FDA approval of cannabidiol for the treatment of two pediatric epilepsy orphan diseases. We see a similar opportunity with our international trial in acute myocarditis to fast track the development of our CardiolRx formulation for a serious cardiovascular orphan disease for which there is currently no accepted standard of care.

Members of Cardiols Acute Myocarditis CSC include:

Dennis M. McNamara, MD (Chair)

Dr. Dennis McNamara is a Professor of Medicine at the University of Pittsburgh. He is also the Director of the Heart Failure/Transplantation Program at the University of Pittsburgh Medical Center. Dr. McNamara received his undergraduate/graduate education at Yale University, New Haven, Connecticut, and Harvard Medical School, Boston, Massachusetts, respectively. He completed his internship, residency, and cardiology fellowship at Massachusetts General Hospital in Boston. McNamaras current research interests include etiology and pathogenesis of dilated cardiomyopathies; inflammatory syndromes of cardiovascular disease; myocardial recovery in recent onset non-ischemic primary cardiomyopathy; etiology and management of peripartum cardiomyopathy; and genetic modulation of outcomes in cardiovascular disease.

Leslie T. Cooper, Jr., MD (Co-Chair)

Dr. Leslie T. Cooper, Jr., is a general cardiologist and the chair of the Mayo Clinic Enterprise Department of Cardiovascular Medicine, as well as chair of the Department of Cardiovascular Medicine at the Mayo Clinic in Florida. Dr. Coopers clinical interests and research focus on clinical and translational studies of rare and undiagnosed cardiomyopathies, myocarditis, and inflammatory cardiac and vascular diseases, such as giant cell myocarditis, cardiac sarcoidosis, eosinophilic myocarditis, and Takayasus arteritis. He has published over 130 original peer-reviewed papers, as well as contributing to and editing books on myocarditis. In addition to his clinical and research work, Dr. Cooper is a fellow of the American College of Cardiology, the American Heart Association, the European Society of Cardiology Heart Failure Association, the International Society for Heart and Lung Transplantation, and the Society for Vascular Medicine and Biology. He is also the founder and former president of the Myocarditis Foundation and continues to serve on its Board of Directors.

Arvind Bhimaraj, MD

Dr. Arvind Bhimaraj is a specialist in Heart Failure and Transplantation Cardiology and is Assistant Professor of Cardiology, Institute for Academic Medicine, at Houston Methodist and at Weill Cornell Medical College, NYC. He has been Co-Director of the Heart Failure Research Laboratory at Houston Methodist since 2016. His area of focus is anti-fibrotic mechanisms and how to promote recovery of a damaged heart. Dr. Bhimaraj was a Heart Failure Fellow at the Cleveland Clinic from July 2010 to September 2011. Dr. Bhimaraj also specializes in Interventional Cardiology, is board certified in Cardiovascular Disease, and the author of numerous cardiovascular publications.

Matthias Friedrich, MD

Dr. Matthias Friedrich is Full Professor with the Departments of Medicine and Diagnostic Radiology at the McGill University in Montreal and Chief, Cardiovascular Imaging at the McGill University Health Centre. He is also Professor of Medicine at Heidelberg University in Germany. Dr. Friedrich earned his MD at the Friedrich-Alexander-University Erlangen-Nrnberg, Germany. He completed his training as an internist and cardiologist at the Charit University Medicine Center, Humboldt University in Berlin. Dr. Friedrich founded one of the first large Cardiovascular Magnetic Resonance centres in Germany at the Charit University Hospital in Berlin. After his move to Canada, from 2004 to 2011, he was Director of the Stephenson Cardiovascular MR Centre at the Libin Cardiovascular Institute of Alberta and Professor of Medicine within the Departments of Cardiac Sciences and Radiology at the University of Calgary, Canada. From 2011 to 2015, he directed the Philippa and Marvin Carsley Cardiovascular MR Centre at the Montreal Heart Institute and was Michel and Renata Hornstein Chair in Cardiac Imaging at the Universit de Montral.

Peter Liu, MD

Dr. Peter Liu is the Chief Scientific Officer and Vice President, Research, of the University of Ottawa Heart Institute, and Professor of Medicine and Physiology at the University of Toronto and University of Ottawa. He was the former Scientific Director of the Institute of Circulatory and Respiratory Health at the Canadian Institutes of Health Research, the major federal funding agency for health research in Canada. Prior to that role, he was the inaugural Director of the Heart & Stroke/Lewar Centre of Excellence in Cardiovascular Research at University of Toronto. Dr. Liu received his MD from the University of Toronto, and postgraduate training at Harvard University. His laboratory investigates the causes and treatments of heart failure, the role of inflammation, and the identification of novel biomarkers and interventions in cardiovascular disease. Dr. Liu has published over 300 peer-reviewed articles in high impact journals and received numerous awards in recognition of his research and scientific accomplishments.

Wai Hong Wilson Tang, MD

Dr. Wai Hong Wilson Tang is the Advanced Heart Failure and Transplant Cardiology specialist at the Cleveland Clinic in Cleveland, Ohio. Dr. Tang is also the Director of the Cleveland Clinics Center for Clinical Genomics; Research Director, and staff cardiologist in the Section of Heart Failure and Cardiac Transplantation Medicine in the Sydell and Arnold Miller Family Heart & Vascular Institute at the Cleveland Clinic. He attended and graduated from Harvard Medical School in 1996, having over 23 years of diverse experience, especially in Advanced Heart Failure and Transplant Cardiology. Dr. Tang is affiliated with many hospitals including the Cleveland Clinic and cooperates with other doctors and physicians in medical groups including The Cleveland Clinic Foundation.

Barry Trachtenberg, MD

Dr. Barry H. Trachtenberg is a cardiologist specializing in heart failure and cardiac transplantation. He is also the director of the Michael DeBakey Cardiology Associates Cardio-Oncology program, an evolving field devoted to prevention and management of cardiovascular complications of cancer therapies such as chemotherapy and radiation. His clinical experience includes heart failure and heart transplantation, mechanical support pumps, and cardio-oncology. He has contributed to multiple publications related to advanced heart failure, cardiac transplantation, regenerative therapies, and ventricular assist devices. Dr. Trachtenberg is a member of the American Heart Association, the International Society for Heart and Lung Transplantation, the Heart Failure Society of America, and the International CardiOncology Society of North America.

Carsten Tschpe, MD

Dr. Carsten Tschpe is Professor of Medicine and Cardiology and Vice Director of the Department of Internal Medicine and Cardiology, Charit University Medicine Berlin. He received his doctorate in medicine in 1993 and has over 140 peer-reviewed publications, including overview and book articles, and 120 international original articles. His research interests include inflammatory cardiomyopathy, diabetic cardiopathy, and ischemic cardiopathy. He also includes diastolic dysfunction, endothelial dysfunction, peptide systems, and experimental and clinical studies in cardiology and stem cells in his research studies. For his outstanding research work, Dr. Tschpe was awarded the prestigious Arthur Weber Prize by the German Cardiac Society Cardiovascular Research.

About Cardiol Therapeutics

Cardiol Therapeutics Inc. (TSX: CRDL)(OTCQX: CRTPF) is focused on producing pharmaceutical cannabidiol (CBD) products and developing innovative therapies for heart disease, including acute myocarditis and other causes of heart failure. The Companys lead product, CardiolRx, is designed to be one of the safest and most consistent CBD formulations on the market. CardiolRx is pharmaceutically produced, cGMP certified, and is THC free. The Company plans to commercialize CardiolRx in the billion-dollar market for medicinal cannabinoids in Canada and is also pursuing distribution opportunities in Europe and Latin America.

In heart failure, Cardiol is planning an international clinical study of CardiolRx in acute myocarditis, a condition caused by inflammation in heart tissue, which remains the most common cause of sudden cardiac death in people less than 35 years of age. The Company is also developing proprietary nanotechnology to uniquely deliver pharmaceutical CBD and other anti-inflammatory drugs directly to sites of inflammation in the heart that are associated with heart failure. Heart failure is the leading cause of death and hospitalization in North America with associated healthcare costs in the U.S. alone exceeding $30 billion. For further information about Cardiol Therapeutics, please visitwww.cardiolrx.com.

For further information, please contact:

David Elsley, President & CEO+1.289.910.0850david.elsley@cardiolrx.com

Trevor Burns, Investor Relations+1.289.910.0855trevor.burns@cardiolrx.com

Cautionary statement regarding forward-looking information:

This news release contains forward-looking information within the meaning of applicable Canadian securities laws. All statements, other than statements of historical fact, that address activities, events or developments that Cardiol Therapeutics Inc. (Cardiol) believes, expects or anticipates will, may, could or might occur in the future are forward- looking information. Forward-looking information is frequently identified by the use of words such as plans, expects, projects, intends, believes, anticipates, forecasts, and other similar words and phrases, including variations (and negative variations) of such words and phrases, or may be identified by statements to the effect that certain actions, events or conditions may, could, should, would, or will be taken, occur or be achieved. Forward-looking information contained herein may include, but is not limited to, statements with respect to: future events; the future performance or the intended business strategy of Cardiol, including, but not limited to, the plan to commercialize CardiolRx100 and the planning of an international clinical study of CardiolRx in acute myocarditis; the potential for Cardiols licensed drug encapsulation and delivery technologies to enhance the bioavailability of pharmaceuticals; managements expectations regarding estimated future pharmaceutical research and development opportunities, collaborations and prospects; the success and proposed timing of Cardiols product development activities; the ability of Cardiol to develop its product candidates; Cardiols plans to research, discover, evaluate and develop additional products; Cardiols proposed future collaborations to advance Cardiols lead nanoformulations into clinical development; and the potential for Cardiols cannabinoid-based products to provide sources of future revenue. Forward-looking information contained herein reflects the current expectations or beliefs of Cardiol based on information currently available to it and is subject to a variety of known and unknown risks and uncertainties and other factors that could cause the actual events or results to differ materially from any future results, performance or achievements expressed or implied by the forward-looking information. These risks and uncertainties and other factors include that the success of Cardiols product candidates will require significant capital resources and years of clinical development efforts; the results of clinical testing and trial activities of Cardiols products; Cardiols ability to obtain regulatory approval and market acceptance of its products; Cardiols ability to raise capital and the availability of future financing; Cardiols lack of operating history; unforeseeable deficiencies in the development of Cardiols product candidates; uncertainties relating to the availability and costs of financing needed in the future for Cardiols research and development initiatives; Cardiols ability to manage its research, development, growth and operating expenses; the potential failure of clinical trials to demonstrate acceptable levels of safety and efficacy of Cardiols product candidates; Cardiols ability to retain key management and other personnel; risks related to fluctuations in medicinal cannabinoid markets in Canada and worldwide; uncertainties regarding Cardiols ongoing collaborative and manufacturing partnerships; uncertainties regarding results of researching and developing products for human use; Cardiol competes in a highly competitive and evolving industry; Cardiols ability to obtain and maintain current and future intellectual property protection; and other risks and uncertainties and factors. These risks, uncertainties and other factors should be considered carefully, and investors should not place undue reliance on the forward-looking information. Any forward-looking information speaks only as of the date on which it is made and, except as may be required by applicable securities laws, Cardiol disclaims any intent or obligation to update or revise such forward-looking information, whether as a result of new information, future events or results or otherwise. Although Cardiol believes that the expectations reflected in the forward-looking information are reasonable, they do involve certain assumptions, risks, and uncertainties and are not (and should not be considered to be) guarantees of future performance. It is important that each person reviewing this news release understands the significant risks attendant to the operations of Cardiol.

Click here to connect with Cardiol Therapeutics Inc. (TSX:CRDL) for an Investor Presentation.

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Cardiol Therapeutics Announces Clinical Steering Committee for Phase 2 International Trial in Acute Myocarditis Using CardiolRx(TM) 100 | INN -...

Cardiac Stem Cells Comments Off on Cardiol Therapeutics Announces Clinical Steering Committee for Phase 2 International Trial in Acute Myocarditis Using CardiolRx(TM) 100 | INN -… | November 25th, 2019

Stem cells are incredible. Science is only starting to scratch the surface of how these amazing cells can help people suffering from heart failure and other cardiovascular issues. Heres some information on what stem cells are, and how they may help heart attack patients and others who have problems involving their heart tissue.

There are more than 200 kinds of cells in the body, and each type is specifically structured for the job its supposed to do. There are skin cells, nerve cells, and cells that form heart tissue and other tissues in the body.1

Theyre found in bone marrow, blood vessels, the liver, the brain, and other parts of the body. Stem cells are even found in the umbilical cord. These sophisticated cells change over time as the body matures. Some of them disappear shortly after youre born, while others stay with you for a lifetime.2

There are three main types of stem cells tissue-specific (adult stem cells), embryonic stem cells, and induced pluripotent (iPS) stem cells. Heres a quick look at each type:

These typically reside in a specific organ, generating other cells to support the health of that organ. They replace those that are lost through injury, or through everyday living.3

Embryonic stem cells form about three to five days after a sperm fertilizes an egg. These are also known as pluripotent cells. This simply means they can develop into any sort of cell the body needs to develop.4

Embryonic cells have been the source of a massive controversy. The main reason is that harvesting these cells destroys the embryo.5 Scientists are working to develop iPS cells that come from adult stems cells rather than embryonic cells. Early research indicates that these cells may share many of the same characteristics of embryonic cells. But there are differences between the two, and there is more work to be done before scientists know exactly what those differences are.6

Research is ongoing into the potential use of stem cells for heart health. For example, work is being done to see if stem cells can help improve heart attack survival rates. Scientists are also looking into the potential for giving a patient their own cardiac stem cells after a heart attack, or even giving patients non-cardiac stem cells from a donor after an attack takes place.7

The goal of this research is to eventually provide cardiac patients with stem cells that can regenerate heart tissue that has been damaged. Some researchers feel that these advances are imminent, while others believe there is a great deal of work yet to be done.8

Early results from ongoing clinical trials involving stem cells for heart health are extremely promising. In one study, a group of 109 patients suffering from heart failure received either stem cell therapy or a placebo. According to the results, the patients who received stem cells were at significantly lower risk of hospitalization or death due to a sudden worsening of their condition.9

Heart failure affects more than 5 million people in the U.S.10 It occurs when the heart gradually weakens to the point to where it cant pump enough blood to meet the needs of the rest of the body. For those with severe heart failure, the only options are either to have a heart transplant or have a device planted to help the heart continue pumping. And even this is only a temporary measure theyll still need a transplant.11

Another study involved the use of stem cells from the umbilical cord. This trial involved 30 heart failure patients. Like the previous study, one group received stem cells while the other received a placebo. The umbilical cords were donated by healthy mothers whose babies were delivered through cesarean section.12

According to the results, the hearts of patients who received the umbilical cord stem cells pumped better than those of the placebo group. The stem cell patients also showed improved quality of life and day-to-day functioning. In addition, the stem cell group did not report any adverse effects, such as immune system reactions.13

As you can see, the use of stem cells to treat heart patients shows great promise. But this is still an extremely young scientific field, and a great deal more research must be performed. Many questions have to be answered, such as what approaches to stem cell harvesting will work the best and what types of side effects are possible from stem cell treatment.

However, this research does bring hope. And hope is something that is incredibly important to many of those suffering from severe cardiac illnesses.

Learn More:How Cardio Can Change Your Brain (And Why Thats Good News!)NEWS: A Vaccine For Arthritis Is Closer Than You ThinkAre Organ Donors At Risk of Becoming Obsolete?

Sources1.https://askabiologist.asu.edu/questions/human-cell-types2.https://www.medicalnewstoday.com/info/stem_cell3.http://www.closerlookatstemcells.org/learn-about-stem-cells/types-of-stem-cells4.https://stemcells.nih.gov/info/basics/3.htm5.http://www.cnn.com/2013/07/05/health/stem-cells-fast-facts/index.html6.http://www.closerlookatstemcells.org/learn-about-stem-cells/types-of-stem-cells#induced-pluripotent7.https://my.clevelandclinic.org/health/diseases/17508-stem-cell-therapy-for-heart-disease8.https://www.health.harvard.edu/heart-health/repairing-the-heart-with-stem-cells9.https://www.ncbi.nlm.nih.gov/pubmed/2705988710.https://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_heart_failure.htm11.http://www.heart.org/HEARTORG/Conditions/HeartFailure/TreatmentOptionsForHeartFailure/Devices-and-Surgical-Procedures-to-Treat-Heart-Failure_UCM_306354_Article.jsp#.WleO-yMrJ3k12.https://www.medicalnewstoday.com/articles/319552.php13.http://circres.ahajournals.org/content/early/2017/09/15/CIRCRESAHA.117.310712

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Stem Cells For Heart Health: What The Current Research ...

Cardiac Stem Cells Comments Off on Stem Cells For Heart Health: What The Current Research … | November 25th, 2019

Stem cells are undifferentiated biological cells, and having remarkable potential to divide into any kind of other cells. When a stem cell divides, each new cell will be a new stem cell or it will be like another cell which is having specific function such as a muscle cell, a red blood cell, brain cell and some other cells.

There are two types of stem cells

Stem cells harvested from umbilical cord blood just after birth. And this cells can be stored in specific conditions. Stem cells also can be harvest from bone marrow, adipose tissue.

Embryonic cells can differentiate into ectoderm, endoderm and mesoderm in developing stage. Stem cells used in the therapies and surgeries for regeneration of organisms or cells, tissues.

Stem cells are used for the treatment of Gastro intestine diseases, Metabolic diseases, Immune system diseases, Central Nervous System diseases, Cardiovascular diseases, Wounds and injuries, Eye diseases, Musculoskeletal disorders.

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Harvesting of Adult cell is somewhat difficult compare to embryonic cells. Because Adult cells available in the own body and it is somewhat difficult to harvest.

Stem Cell TherapiesMarket: Drivers and Restraints

Technology advancements in healthcare now curing life threatening diseases and giving promising results. Stem Cell Therapies having so many advantages like regenerating the other cells and body organisms. This is the main driver for this market. These therapies are useful in many life threatening treatments. Increasing the prevalence rate of diseases are driven the Stem Cell Therapies market, it is also driven by increasing technology advancements in healthcare. Technological advancements in healthcare now saving the population from life threatening complications.

Increasing funding from government, private organizations and increasing the Companies focus onStem cell therapiesare also driven this market

However, Collecting the Embryonic Stem cells are easy but Collecting Adult Stem cell or Somatic Stem cells are difficult and also we have to take more precautions for storing the collected stem cells.

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Stem Cell TherapiesMarket: Segmentation

Stem Cell Therapies are segmented into following types

Based on treatment:

Based on application:

Based on End User:

Stem Cell TherapiesMarket: Overview

With rapid technological advantage in healthcare and its promising results, the use of Stem Cell Therapies will increase and the market is expected to have a double digit growth in the forecast period (2015-2025).

Stem Cell TherapiesMarket: Region- wise Outlook

Depending on geographic regions, the global Stem Cell Therapies market is segmented into seven key regions: North America, South America, Eastern Europe, Western Europe, Asia Pacific excluding Japan, Japan and Middle East & Africa.

The use of Stem Cell Therapies is high in North America because it is highly developed region, having good technological advancements in healthcare setup and people are having good awareness about health care. In Asia pacific region china and India also having rapid growth in health care set up. Europe also having good growth in this market.

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Stem Cell TherapiesMarket: Key Players

Some of the key players in this market are

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Stem Cell Therapies Market research to Witness a Healthy Growth during 2015 2025 - Lake Shore Gazette

Bone Marrow Stem Cells Comments Off on Stem Cell Therapies Market research to Witness a Healthy Growth during 2015 2025 – Lake Shore Gazette | November 25th, 2019

What are stem cells and what role can they play in medicine andresearch? Stem cell research offers exciting possibilities in terms ofregenerative medicine. However, there are ethical controversies and challengesimpeding the fields advancement. In this article, The Medium presents a briefoverview of the unique abilities, applications, and challenges of stem cells.

According tothe National Institute of Health, stem cells are able to develop into manydifferent cell types in the body during early life and growth. When stem cellsdivide, the new cell can become another stem cell or it can become aspecialized cell such as a muscle cell or a brain cell. Stem cells provide newcells for the body as it grows and replaces damaged or lost specialized cells.The two unique properties of stem cells are that the stem cells can dividemultiple times to produce new cells, and as they divide, the stem cells cangenerate other types of cells found in the body.

In organs suchas the gut and the bone marrow (the soft tissue inside most bones), stem cellsroutinely divide to replace damaged tissue. However, in other organs such asthe heart, stem cells require certain physiological conditions to facilitate celldivision.

Stem cells canbe divided into two categories: embryonic stem cells and adult stem cells.Embryonic stem cells are derived from a blastocystan early stage of embryodevelopment. The blastocyst contains the trophectoderm, which will eventuallyform the placenta, and the inner cell mass, which will develop into the embryo,and later into the organism. Stem cells taken from the inner cell mass arepluripotentthey can develop into any cell type in the body. The embryonic stemcells used in research are sourced from unused embryos that were a result of anin vitro fertilization procedure and were donated for scientific research.

Adult stemcells also have the ability to divide into more than one cell type; however,they are often restricted to certain types of cells. For example, an adult stemcell found in the liver will only divide into more liver cells. In 2006, ShinyaYamanaka, a Japanese stem cell researcher, discovered how to program inducedpluripotent stem cells (iPSCs). iPSCs are adult cells which have beengenetically reprogrammed into a pluripotent embryonic stem cell-like state.Yamanaka won the Nobel Prize for Physiology or Medicine alongside Englishdevelopmental biologist Sir John Gurdon in 2012 for this important discovery.

There arenumerous ways in which stem cells can be used. Firstly, human embryonic stemcells can provide information as to how cells divide into tissues and organs.Abnormal cell division can cause cancer and birth defects, and therefore, amore comprehensive understanding of the processes underlying cell division maysuggest new therapy strategies. Another beneficial avenue involves drug testingas new medications could be tested on cells developed from stem cells in thelab. However, a challenge for researchers is to create an environment identicalto the conditions found in the human body.

Finally, stemcells present exciting possibilities in cell-based therapies and regenerativemedicine. Instead of relying on a limited supply of donated organs and tissuesto replace damaged and destroyed ones, stem cells could be directed to developinto the desired cell type and treat diseases such as heart disease, diabetes,and spinal cord injuries. For example, healthy heart muscle cells could begenerated from stem cells in a laboratory and transplanted into an individualwith heart disease. However, there is still research and testing which needs tobe conducted before researchers can confirm how to effectively and safely usestem cells to treat serious disease.

As explainedby the University of Rochesters medical centre, there are several challengesassociated with stem cells. Researchers first need to learn about how embryonicstem cells develop so that they can control the type of cells generated fromstem cells. Scientists also need to determine how to ensure that the cellsdeveloped from stem cells in the lab are not rejected by the human body. Adultpluripotent stem cells are found in small amounts in the human body and arehard to grow in the lab. There are also numerous ethical issues surrounding theuse of embryonic stem cells as some individuals believe that using cells froman unused blastocyst and consequently, rendering it incapable to develop intoan organism, is similar to destroying an unborn child. Others argue that theblastocyst is not a child yet as it needs to be imbedded into the mothersuterus wall before it has the chance to develop into a fetus. Supporters ofembryonic stem cell research also say that many surplus blastocysts aredestroyed in fertility clinics and can be better used to research medicaltreatments which could save peoples lives.

Students canlearn more about stem cells in BIO380H5: Human Development. Furthermore, Dr.Ted Erlicks lab at UTM is researching how complex neural circuits developfrom an initial population of stem cells. Stem cell research offers promisingavenues of treating diseases and understanding how humans develop. However,there is still a substantial amount of research which needs to be conducted andethical concerns which need to be appropriately addressed and resolved.

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Stem cells' role in medicine and research - The Medium

Spinal Cord Stem Cells Comments Off on Stem cells’ role in medicine and research – The Medium | November 25th, 2019

The mother of a hockey player paralyzed in the Humboldt Broncos bus crash says shes stunned by the progress he has made since receiving spinal surgery in Thailand.

Doctors implanted an epidural stimulator in Ryan Straschnitzkis spine earlier this month and a week later injected stem cells above and below the injury in the hope that will help reverse some of the damage.

Ryan Straschnitzki was presented a jersey as hockey players from the non-profit PX3 AMP Sledge Hockey Academy have been endorsed by the Calgary Flames as its affiliate sledge hockey team at the upcoming 2019 USA Hockey Sled Classic presented by the NHL in St. Louis from Nov. 21 Nov. 24, 2019 at the Scotiabank Saddledome in Calgary on Wednesday, October 30, 2019. Darren Makowichuk/PostmediaDarren Makowichuk / DARREN MAKOWICHUK/Postmedia

The 20-year-old from Airdrie, Alta., is to remain in Thailand until early December.

Hands down Im 200 per cent behind this. I didnt expect this kind of result this quickly, Michelle Straschnitzki said in an interview. Its definitely not a quick fix. Its not a cure, but its certainly progress and its more than weve had in 19 months.

Tom Straschnitzki, who is also in Thailand, has posted a number of videos of his sons rehab, including one where the young man was able to move a leg. Another video shows him strapped into a harness as physiotherapists slowly help him walk with the use of a machine on wheels.

Bout time he got off his ass. 1st time since he boarded the bus that horrendous day, Straschnitzki tweeted.

Therapist helping with knees and ankles so they dont buckle. Ryan did so good, I sent him to the beer store for me.

Straschnitzki was one of 13 players who were injured when an inexperienced truck driver blew through a stop sign and into the path of the Saskatchewan junior hockey teams bus in April 2018. Sixteen others on the bus died.

Straschnitzki, who was paralyzed from the chest down, has said he isnt expecting a cure but hopes the implant will restore some muscle movement and things such as bladder control.

A small device like a remote control is to send electrical currents to his spinal cord to try to stimulate nerves and move limbs. The implant is being programmed to stimulate certain nerves mapped out by surgeons and therapists.

The surgery can cost up to $100,000 and isnt covered by public health care or insurance, because the epidural procedure has not been approved by Health Canada. The family is paying for it themselves. It is also performed in countries such as the United States and Switzerland, but it is much cheaper in Thailand.

The players mother, who didnt go to Thailand, said hes been low key when shes talked to him.

In typical Ryan fashion hes very quiet. All he says is hes very tired and you can tell. His body, his mind, everything is tired because hes pushing as far as he can.

Her son takes part in nerve mapping in the morning, does physio in the afternoon and then does more work with the implant, she said. He still plans to hit the ice in Bangkok with his hockey sledge before returning home.

Straschnitzki said seeing her boys progress on the videos stunned her.

I was just absolutely floored. It obviously brought the tears. I was bawling. It was unreal, she said.

Tom said the last time Ryan walked was when he walked on the bus and then, to watch him moving his legs, walking essentially, that just rocked me.

Humboldt Broncos crash survivor Ryan Straschnitzki takes a moment during practice at Winsport in Calgary, on Aug. 7, 2018.Leah Hennel / Postmedia

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'It was unreal': Mother of injured Bronco Ryan Straschnitzki stunned by his progress after surgery - Saskatoon StarPhoenix

Spinal Cord Stem Cells Comments Off on ‘It was unreal’: Mother of injured Bronco Ryan Straschnitzki stunned by his progress after surgery – Saskatoon StarPhoenix | November 25th, 2019

The era of environmentally conscious users has hit the market; and theres a sharp increase of customers who prefer sustainable life choices. They tend to seek out and promote cruelty-free products and brands. Consumers today are becoming more and more vigilant about the ingredients used in their favourite merchandise, the technology, and science behind it all, especially when it comes to cosmetics.

This change in mindset has created a completely new sector of skincare: vegan products. Completely warding off any animal products or by-products, veganism is becoming the popular choice of the modern world. Having a vegan outlook helps in the detoxing of your body and gives great health benefits to your skin. Plabita Sharma, a skincare expert at The Body Shop, India, underlines some benefits of vegan skincare products:

Skin-friendly: Vegan products are a rich source of nourishment and natural goodness as they are made from plants, minerals, and some safe synthetic ingredients.

Animal-friendly/not tested on animals: While not everyone is an animal rights activist, but knowing the essentials used on your skin are not tested on animals is guilt-free in itself.

Safe from harmful chemicals: Choosing vegan products will save you from harmful chemicals and cruel cosmetics and give you glowing skin.

Prevents various skin problems: Vegan products decreases the chances of skin problems such as rashes, allergies, eczemas, acne, skin inflammation and skin diseases due to lack of chemicals used. These are perfect for sensitive skin.

Remedy for all skin concerns: Ingredients such as Vitamin E, Vitamin A, Red Algae, Coconut Oil, Plant stem cells and alike products benefit the skin addressing all kinds of concerns. Like Vitamin C for radiance, Tea tree oil for grumpy acne, aloe vera to soothe the skin, wheat germ oil to nourish the skin and many more.

(This story has been published from a wire agency feed without modifications to the text. Only the headline has been changed.)

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This is why you should switch to vegan skin care products - Hindustan Times

Skin Stem Cells Comments Off on This is why you should switch to vegan skin care products – Hindustan Times | November 25th, 2019

Discovery of New Method Speeds Up Precision 3D BioprintingAndrew Wheeler posted on November 19, 2019 |

In the world of additive manufacturing (AM), the promises of bioprinting would be truly groundbreaking if they were to be kept and fully realized. The unscalable mountain is the ability to 3D print patient-specific organs. There would be no more organ rejection from transplants in post-operative care. In 2017, Gartner predicted that this medical innovation would occur within a decade.

Currently, simple tissues are 3D printed by various companies. For example, Poietis established and commercialized a laser methodology for 3D printing biological matter like skin cells and liver tissue. They released a commercial skin product in 2018 and established a partnership with LOral and BASF. Another example comes from the company CELLINK. It makes bioprinters used by pharmaceutical researchers in order to test the effects of drugs on living human tissue.

The technology and techniques of 3D bioprinting still have a long way to go before patient-specific organ transplants transform from fantasy to reality. Recent developments from TU Wien in Austria highlight one of the main factors in achieving what is now impossible: speed.

These are living cells photographed in a 3D scaffold. Weeks 1, 3 and 5 are pictured from left to right. The top images show the 3D setup and the bottom shows just one layer. The indications for increased precision and speed are significant for bioprinting and the ultimate goal of 3D printing patient-specific organs for transplants. (Image courtesy of TU Wien.)

The 3D scaffold and bioink developed at TU Wien will allow researchers to achieve new levels of accuracy in ongoing studies about the behavior of cells. The cell behavior as diseases spread is an important aspect of discovering new treatment methods. The introduction of stem cells to the new process makes it possible to create fully customized tissue.

3D bioprinting techniques differ in many ways. Some are less precise while others produce cells that do not last very long. Some cells produced through 3D bioprinting have material properties that limit their efficacy.

Cell behavior can differ greatly depending the chemical properties, shape and mechanical nature of the environment. For example, it is important for the environment to be permeable in order to ensure the survival and multiplication of cells embedded within. Countering that, the environment must strike the right type of balance in respect to stiffness and flexibility so that the structures do not degrade.

The key is to have new environments for embedding the cells, either liquids or gels, that solidify exactly where they are shot with a focused laser beam. The catch-22 is that the laser beam and the materials must not in any way harm the embedded living cells, and it has to happen as rapidly as possible.

TU Wien researchers solved this complex issue by using two-photon polymerization methods. These methods use a chemical reaction that has specific prerequisites for activation. When a molecule of the material that makes up the environment where the living cells are embedded absorbs two photons, an extremely intense laser beam activates a chemical reaction. At the precise point where the two photons are absorbed, the environmental substance stiffens but the surroundings remain liquid. The level of precision and intricacy at which structures can be constructed increases.

This process alone is slow, but using scaffolds has helped researchers develop a method that enables them to print structures in a few hours. Additionally, these new structures have an increased likelihood of surviving and living longer.

Researchers can now define exactly how an environmental structure should behave to foster specific types of cell migration and growth. They also can predict with greater accuracy how long a structure will last and when it will degrade.

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Tonight, the ABC will air a three-part documentary series tackling sexual harassment in the workplace.

Among many other brave and formidable women, one of the people featured in the documentary is me.

Except, ironically, you cant actually know what happened to me. What precisely was done to me, which led me to being on your TV screens. You also cant know how my employers handled the situation. You cant know what happened to that perpetrator.

Despite the name of the documentary, Silent No More, I, for a large part, am legally silenced.

This is absolutely through no fault of the incredible documentary makers, who fought so hard for the inclusion of my story. Rather, the non-disclosure agreement (NDA) I signed when I resigned from the workplace after experiencing ongoing sexual harassment from this one employee.

I suppose one of the questions on your mind must be what compelled me to sign an NDA. I had just turned 18 when the perpetrator walked into my life. I was also 18 when I resigned and the settlement, including the NDA, was processed.

Now 21, I dont think Im far enough away from the experience to truly understand how my age impacted the situation. However, I am certain that when youre 18 and your employers, colleagues and perpetrator arent, the imbalance of power between all parties is only tipped further.

At no age is it easy to stare down the barrel of a sexual harassment case, but when youre 18 years old and receiving letters from lawyers, my mind said to get out. Fast.

When I first told my mum what this man was doing to me at work, I just wanted to resign. I didnt want to report. I just so desperately wanted to get out. I had become terrified and physically sick with fear at work, that I wanted the fastest one-way route out of that place: resignation.

With some convincing from my mum and a lawyer, we started some very simple proceedings. Opening up conversations with the employer about my options. To be transparent, I could have escalated my claim to the states Workplace Health and Safety regulator or taken it to court. It was explained that both of those could be quite long and rigorous processes to endure.

And, like many people who dont report allegations of violence, they were simply processes I could not endure. Few people warned me the process of reporting, which I cant talk about, would incur a different type of trauma to the harassment itself. I still had uni to go to the next day, work in my other jobs, and also be an 18-year-old who didnt run home fuelled by bottled panic from the train station.

So, thats how we came to me resigning and settling. Settlement involves a whole bunch of things and agreements, which you cant know about, but the biggest part of the settlement is the NDA inclusion.

I balanced what the settlement gave me; my safety, against what it took away from me; my ability to explain what had been done to me, and I chose my safety.

Despite the way it tears at my heart that people cant know about my experiences, I would choose my safety again. Because, unfortunately, we still do live in a cruel structure that makes many of us choose.

Safety.

Or, your voice.

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"I was 18 when I came home and told my mum I was being sexually harassed at work." - Mamamia

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In Switzerland we know how to make watches. We also know how to stop time, reads the giant poster in the lobby.

Im at Victoria-Jungfrau Grand Hotel and Spa in Interlaken to sample their Better Aging program and find out if you really can stop the clock and stay looking young or if such ideas are just cuckoo.

The area certainly has a feel of youthful exuberance about it when I arrive Im greeted by paragliders, their colourful canopies drifting down onto the green across from the hotel. During my stay, not a day goes by without seeing the red and yellow wings in death-defying loops.

I can watch them from my room a smart black, brown and gold chamber housing a hard double bed with two single duvets, the traditional Swiss arrangement presumably designed to prevent greedy partners from hogging the covers. Every evening theres a Swiss truffle on my pillow.

The balcony looks out towards the Bernese Alps and the snowy peaks of Jungfrau, which means young woman or maiden. The setting of my anti-ageing quest really couldnt be better.

My journey begins at Nescens Spa, a bright space with lots of natural light, candles and trailing plants.

Spa director Hans-Peter notes down my vitals and bids me stand on a body analysis machine before Im whisked off to a room with personal trainer Brigitte, an intimidatingly fit-looking 49-year-old with a blonde crop.

Its not all bad news I have more muscle than her but I have a lot of body fat (not exactly news to me). She tells me my visceral fat is of particular concern and, among other things, advises me to avoid fruit with a high sugar content such as pineapple and grapes.

The next step is easier to take a de-stressing massage using anti-ageing Nescens oil. This should smoothe the skin and boost cell recapitalisation. The massage is gentler than others Ive had, and quite relaxing, but I cant say my skin looked different afterwards.

The spa does boast outstanding relaxation areas, however. Comfortable couches with mountain views, a smart sauna and the apex of steam rooms with twinkly lights in its starry ceiling, a fountain in middle and a gentle mint scent wafting through the air.

The next morning we come at the ageing issue via exercise with a morning of gentle Pilates. Its run by another uber-fit blonde, Iris.

Then its time for a Better Aging lunch beetroot, goats cheese and orange salad followed by a delicious sea bream with basillicum and vegetables.

Usually guests on the programme stay for at least four days, during which time meals are matched to help them achieve their fitness goals but this cant be easy with a pizzeria, Sapori, as part of the hotel.

The afternoon is dedicated to more exercise a brisk 5km walk with Iris again, through woodland and along the river, emerald with glacier water.

I have the highest hopes for todays anti-ageing treatment a classic silk bliss facial using Sensai products.

My beautician, Nicole, explains how the silk in the range was previously reserved for the Emperor of Japan. Apparently the products can activate your stem cells to help remove wrinkles.

The facial begins with Sensai Silky Purifying Creamy Soap followed by a steamer to open the pores, and some seriously thorough extraction work.

Next came the Silky Purifying Silk Peeling Mask and a mud soap wash and mask, left for six minutes. Finally came four more serums and creams.

My skin looked blotchy but felt very soft afterwards like a velvety cushion. The blotchiness was gone within half an hour, replaced with a glow. The next morning I could feel a spot coming on my neck but my face was plump, smooth and even.

The next day, after a Better Aging breakfast of light bites including tomatos, olives and smoothies, Im back with Brigitte for Nescens Full Body Training. Im cheered by the sight of some pensioners in the class. How hard can it be?

Quite hard, is the answer a full-on but not unbearable 45 minutes of planks, sit ups, star jumps and stretching giant blue elastic bands.

Afterwards I reward myself with a swim in the stunning pool. The main spa has a white, black and gold theme and incredible views.

It also has a lovely outdoor jacuzzi which you swim out to, with bubble beds, jets to massage your feet and back, and a clearer look at the mountains.

At the end of my trip I was more relaxed, my skin felt smoother and I felt fitter. While I may not look younger, as someone approaching 40 Im certainly less stressed about ageing.

Victoria-Jungfrau Grand Hotel and Spa (Picture: Yvette Caster/Metro.co.uk)

Where to stay in Switzerland

Rooms at Victoria-Jungfrau Grand Hotel and Spa cost from 296 per night, with breakfast. Better Aging guests get a 50 per cent discount in high season and 25 per cent discount in low season.

The Better Aging program lasts from four days and costs from 2,499 per person, which includes treatments, personal training and meals.

I flew with Swiss Air from Heathrow to Zrich. Flights cost from 177 return.

To get to the spa I took the train from Zrich airport to Interlaken OST via Bern. Return tickets cost from 116 via Switzerland Tourism. The hotel was about five minutes from the station by taxi.

A Swiss Travel Pass offers unlimited travel throughout the rail, bus and boat network. It includes entrance to 500 museums and costs from 185.

For more on Switzerland visit http://www.MySwitzerland.com.

Where to stay in Heathrow

I stayed at the Radisson Blu Edwardian Heathrow a decadent way to extend the spa experience.

The lobby features an impressive chandelier and theres dark wood and bronzes throughout.

The hotels spa has just had a revamp, and has a relaxation area, cosy sauna, powerful jacuzzi and beautiful blue and gold steam room.

The revamped Radisson spa at the hotel (Picture: Yvette Caster/Metro.co.uk)

I loved the showers you use between each part of the spa. Im sure they would delight fellow Pratchett fans, bringing to mind the Archchancellors bathroom as they do. There were buttons for cold mist, Caribbean storm and waterfall (but thankfully no Old Faithful).

I also tried their chocolate orange massage a thorough, full body treatment. I wasnt overpowered by scent and only really noticed the mild smell of cocoa when it was applied to my chest. It left me feeling refreshed and smelling sweet.

The hotel has two places to dine, Indian restaurant Anayu and Steak and Lobster. My T-bone steak was pleasant, although the blue cheese sauce was a bit bland, while the skinny fries were deliciously seasoned.

I enjoyed chatting to Radissons virtual host, Edward. You can text him anything 24/7 order room service, ask for late checkout and enquire about hotel services. It was like having my own PA.

Rooms at Radisson Blu Edwardian cost from 76.50 per night. They are offering Stay, Park and Fly packages from 102.50 per night, including parking for trips for eight to 15 days.

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The fountain of youth? I tested a better anti-ageing program in Switzerland - Metro.co.uk

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Acne is a bummer, whether it shows up on your big day . . . or just a Monday. Chances are you've had to deal with it at some point in your life. (That's why you're reading this, right?) Whether the problem is hormonal, cystic, or something else entirely, it's pretty safe to say no one is excited when they see a new pimple in the mirror.

Now's the time to break up with breakouts for good. Here are top-rated products to add to your clear skin arsenal, straight from Sephora.

You'll find solutions to brighten and treatments to lighten (old scars), not to mention products that exfoliate skin and zap zits. There's even makeup for pimple-prone skin, too.

If you're ready to stage an acne attack (that's an attack on acne, not of acne), find the blemish-blasting products from Sephora that other shoppers are loving ahead.

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Solve Your Problem (Skin) With These Top-Rated Acne Products From Sephora - POPSUGAR

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The mother of a hockey player paralyzed in the Humboldt Broncos bus crash says shes stunned by the progress he has made since receiving spinal surgery in Thailand.

Doctors implanted an epidural stimulator in Ryan Straschnitzkis spine earlier this month and a week later injected stem cells above and below the injury in the hope that will help reverse some of the damage.

Ryan Straschnitzki was presented a jersey as hockey players from the non-profit PX3 AMP Sledge Hockey Academy have been endorsed by the Calgary Flames as its affiliate sledge hockey team at the upcoming 2019 USA Hockey Sled Classic presented by the NHL in St. Louis from Nov. 21 Nov. 24, 2019 at the Scotiabank Saddledome in Calgary on Wednesday, October 30, 2019. Darren Makowichuk/PostmediaDarren Makowichuk / DARREN MAKOWICHUK/Postmedia

The 20-year-old from Airdrie, Alta., is to remain in Thailand until early December.

Hands down Im 200 per cent behind this. I didnt expect this kind of result this quickly, Michelle Straschnitzki said in an interview. Its definitely not a quick fix. Its not a cure, but its certainly progress and its more than weve had in 19 months.

Tom Straschnitzki, who is also in Thailand, has posted a number of videos of his sons rehab, including one where the young man was able to move a leg. Another video shows him strapped into a harness as physiotherapists slowly help him walk with the use of a machine on wheels.

Bout time he got off his ass. 1st time since he boarded the bus that horrendous day, Straschnitzki tweeted.

Therapist helping with knees and ankles so they dont buckle. Ryan did so good, I sent him to the beer store for me.

Straschnitzki was one of 13 players who were injured when an inexperienced truck driver blew through a stop sign and into the path of the Saskatchewan junior hockey teams bus in April 2018. Sixteen others on the bus died.

Straschnitzki, who was paralyzed from the chest down, has said he isnt expecting a cure but hopes the implant will restore some muscle movement and things such as bladder control.

A small device like a remote control is to send electrical currents to his spinal cord to try to stimulate nerves and move limbs. The implant is being programmed to stimulate certain nerves mapped out by surgeons and therapists.

The surgery can cost up to $100,000 and isnt covered by public health care or insurance, because the epidural procedure has not been approved by Health Canada. The family is paying for it themselves. It is also performed in countries such as the United States and Switzerland, but it is much cheaper in Thailand.

The players mother, who didnt go to Thailand, said hes been low key when shes talked to him.

In typical Ryan fashion hes very quiet. All he says is hes very tired and you can tell. His body, his mind, everything is tired because hes pushing as far as he can.

Her son takes part in nerve mapping in the morning, does physio in the afternoon and then does more work with the implant, she said. He still plans to hit the ice in Bangkok with his hockey sledge before returning home.

Straschnitzki said seeing her boys progress on the videos stunned her.

I was just absolutely floored. It obviously brought the tears. I was bawling. It was unreal, she said.

Tom said the last time Ryan walked was when he walked on the bus and then, to watch him moving his legs, walking essentially, that just rocked me.

Humboldt Broncos crash survivor Ryan Straschnitzki takes a moment during practice at Winsport in Calgary, on Aug. 7, 2018.Leah Hennel / Postmedia

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'It was unreal': Mother of injured Bronco Ryan Straschnitzki stunned by his progress after surgery - The Province

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Aristotle already observed in the fourth century B.C. that some animals can regrow their tails after losing them, but the mechanisms that support this kind of regeneration remain difficult to understand.

Using single-cell genomics, scientists at the Wellcome Trust / Cancer Research UK Gurdon Institute at the University of Cambridge developed an innovative strategy to show what happens in different tadpole cells when they regenerate their tails.

Recent advances at Cambridge in next-generation single-cell sequencing mean that scientists can now track which genes are turned on throughout a whole organism or tissue, at the resolution of individual cells. This technique, known as single-cell genomics, makes it possible to distinguish between cell types in more detail based on their characteristic selection of active genes.

These groundbreaking discoveries are beginning to reveal a map of cellular identities and lineages, as well as the factors involved in controlling how cells choose between alternative pathways during embryo development to produce the range of cell types in adults.

Using this technology, Can Aztekin and Dr Tom Hiscock under the direction of Dr Jerome Jullien made a detailed analysis of cell types involved in regeneration after damage in African clawed frog tadpoles (Xenopus laevis). Details were published in the journal Science.

Dr Tom Hiscock said: Tadpoles can regenerate their tails throughout their life; but there is a two-day period at a precise stage in development where they lose this ability. We exploited this natural phenomenon to compare the cell types present in tadpoles capable of regeneration and those no longer capable.

The researchers found that the regenerative response of stem cells is orchestrated by a single sub-population of skin cells, which they named Regeneration-Organizing Cells, or ROCs.

Can Aztekin said: Its an astonishing process to watch unfold. After tail amputation, ROCs migrate from the body to the wound and secrete a cocktail of growth factors that coordinate the response of tissue precursor cells. These cells then work together to regenerate a tail of the right size, pattern and cell composition.

In mammals, many tissues such as the skin epidermis, the intestinal epithelium and the blood system, undergo constant turnover through life. Cells lost through exhaustion or damage are replenished by stem cells. However, these specialised cells are usually dedicated to tissue sub-lineages, while the ability to regenerate whole organs and tissues has been lost in all but a minority of tissues such as liver and skin.

Professor Benjamin Simons, a co-author of the study said: Understanding the mechanisms that enable some animals to regenerate whole organs represents a first step in understanding whether a similar phenomenon could be reawakened and harnessed in mammalian tissues, with implications for clinical applications.

This research was funded by the University of Cambridge, the Cambridge Trust andthe Wellcome Trust;and supported by theEuropean Molecular Biology Organization, the Royal Society,theEuropean Molecular Biology Laboratory, and Cancer Research UK.

Source: University of Cambridge Research

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Scientists find a cell that helps tadpoles tails regrow - Fourways Review

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DetailsCategory: Small MoleculesPublished on Friday, 22 November 2019 14:04Hits: 311

Two Phase III Calquence trials demonstrated superior progression-free survival across multiple settings while maintaining favourable tolerability

Calquence combined with obinutuzumab and as monotherapy reducedthe risk of disease progression or death by 90% and 80%, respectively in ELEVATE-TN

LONDON, UK I November 21, 2019 I AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Calquence (acalabrutinib) for adult patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).1 The US approval was granted under the FDAs Real-Time Oncology Review and newly established Project Orbis programmes.

The approval is based on positive results from the interim analyses of two Phase III clinical trials, ELEVATE-TN in patients with previously untreated CLL and ASCEND in patients with relapsed or refractory CLL. Together, the trials showed that Calquence in combination with obinutuzumab or as a monotherapy significantly reduced the relative risk of disease progression or death versus the comparator arms in both 1st-line and relapsed or refractory CLL. Across both trials, the safety and tolerability of Calquence were consistent with its established profile.1

Dave Fredrickson, Executive Vice President, Oncology Business Unit said: With over 20,000 new cases anticipated this year in the US alone, todays approval of Calquence provides new hope for patients with one of the most common types of adult leukaemia, offering outstanding efficacy and a favourable tolerability profile. The chronic lymphocytic leukaemia patient population is known to face multiple comorbidities, and tolerability is a critical factor in their treatment.

Dr Jeff Sharman, Director of Research at Willamette Valley Cancer Institute, Medical Director of Hematology Research for The US Oncology Network, and a lead author of the ELEVATE-TN trial, said: Tolerability remains an issue in the current treatment landscape of chronic lymphocytic leukaemia, which may require ongoing therapy for many years. In the ELEVATE-TN and ASCEND trials comparing Calquence to commonly used treatment regimens, Calquence demonstrated a clinically meaningful improvement in progression-free survival in patients across multiple settings, while maintaining its favourable tolerability and safety profile.

The results of the interim analysis of the ELEVATE-TN trial will be presented at the upcoming American Society of Hematology congress.2

The trial showed a statistically significant and clinically meaningful improvement in progression-free survival (PFS) for patients treated with either Calquence in combination with obinutuzumab or Calquence monotherapy versus chlorambucil chemotherapy plus obinutuzumab, a current standard-of-care combination used in the control arm.1

In the Calquence combination arm, risk of disease progression or death was reduced by 90% (HR 0.10; 95% CI, 0.06-0.17, p<0.0001) and in the monotherapy arm it was reduced by 80% (HR 0.20; 95% CI, 0.13-0.30, p<0.0001).1

The median time to disease progression for patients treated with Calquence in combination with obinutuzumab or as a monotherapy has not yet been reached versus 22.6 months (95% CI, 20-28) for chlorambucil plus obinutuzumab.1

ELEVATE-TN safety overview (most common ARs, 15%):1

Includes multiple ADR terms.

In patients treated with the combination of Calquence plus obinutuzumab, adverse reactions (ARs) led to treatment discontinuation in 11% of patients and a dose reduction of Calquence in 7% of patients. In the monotherapy arm, ARs led to discontinuation in 10% and dose reduction in 4% of patients.1 In the control arm, ARs led to regimen discontinuation in 14% of patients with a dose reduction of chlorambucil in 28% of patients.3 There were no dose reductions for obinutuzumab.1,3

In 1,029 patients with haematologic malignancies who were treated with Calquence 100mg approximately every 12 hours across multiple clinical trials, where 88% received treatment for at least six months and 79% received treatment for at least one year, serious or Grade 3 infections occurred in 19%, and Grade 3 atrial fibrillation and flutter occurred in 1.1% of patients.In the same patient population, major haemorrhage occurred in 3.0% (serious or Grade 3 bleeding or any central nervous system bleeding), with fatal haemorrhage occurring in 0.1% of patients. Second primary malignancies (all grades) including skin cancers occurred in 12% of patients.1

The US approval is among the first to be granted under Project Orbis, an initiative of the US FDA Oncology Center of Excellence, which provides a framework for concurrent submission and review of oncology medicines among international partners. The FDA, the Australian Therapeutic Goods Administration, and Health Canada collaborated on this review. 4

About Calquence

In the US, Calquence (acalabrutinib) is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL)/small lymphocytic lymphoma (SLL). In the US, Canada, Australia, Brazil, Qatar, the United Arab Emirates, Mexico, Argentina, Singapore, Chile, and recently India, Calquence is indicated for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Approved under accelerated review in the US, continued approval for previously treated MCL is contingent upon verification and confirmation of clinical benefit in confirmatory trials.

Calquence is a next-generation selective inhibitor of Brutons tyrosine kinase (BTK). Calquence binds covalently to BTK, thereby inhibiting its activity.1,5,6,7 In B-cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.1

As part of an extensive clinical development programme, AstraZeneca and Acerta Pharma are currently evaluating Calquence in 23 company-sponsored clinical trials. Calquence is being developed for the treatment of multiple B-cell blood cancers including CLL, MCL, diffuse large B-cell lymphoma, Waldenstrm macroglobulinaemia and follicular lymphoma and other haematologic malignancies. Several Phase III clinical trials in CLL are ongoing, including ASCEND, ELEVATE-TN, ELEVATE-RR (ACE-CL-006) evaluating Calquence versus ibrutinib in patients with previously treated high-risk CLL, and ACE-CL-311 evaluating Calquence in combination with venetoclax and with/without obinutuzumab versus chemoimmunotherapy in patients with previously untreated CLL without 17p deletion or TP53 mutation.

About ELEVATE-TN

ELEVATE-TN (ACE-CL-007) is a randomised, multicentre, open-label Phase III trial evaluating the safety and efficacy ofCalquence in combination with obinutuzumab, a CD20 monoclonal antibody, or Calquence alone versus chlorambucil, a chemotherapy, in combination with obinutuzumab in previously untreated patients with CLL. In the trial, 535 patients were randomised (1:1:1) into three arms. Patients in the first arm received chlorambucil in combination with obinutuzumab. Patients in the second arm received Calquence (100mg twice daily until disease progression or unacceptable toxicity) in combination with obinutuzumab. Patients in the third arm received Calquence monotherapy (100mg twice daily until disease progression or unacceptable toxicity).1,8

The primary endpoint is PFS in the Calquence and obinutuzumab arm compared to the chlorambucil and obinutuzumab arm, assessed by an independent review committee (IRC), and a key secondary endpoint is IRC-assessed PFS in the Calquence monotherapy arm compared to the chlorambucil and obinutuzumab arm. Other secondary endpoints include objective response rate, time to next treatment and overall survival.1,8

About ASCEND

ASCEND (ACE-CL-309) is a global, randomised, multicentre, open-label Phase III trial evaluating the efficacy of Calquence in previously treated patients with CLL. In the trial, 310 patients were randomised (1:1) into two arms. Patients in the first arm received Calquence monotherapy (100mg twice daily until disease progression or unacceptable toxicity). Patients in the second arm received investigators choice of either rituximab, a CD20 monoclonal antibody, in combination with idelalisib, a PI3K inhibitor, or rituximab in combination with bendamustine, a chemotherapy.1,9

The primary endpoint is PFS assessed by an IRC, and key secondary endpoints include physician-assessed PFS, IRC- and physician-assessed overall response rate and duration of response, as well as overall survival, patient-reported outcomes and time to next treatment.1,9

About CLL

Chronic lymphocytic leukaemia (CLL) is one of the most common types of leukaemia in adults, with an estimated 105,000 new cases globally each year and 20,720 new cases in the US in 2019, and the number of people living with CLL is expected to grow with improved treatment as patients live longer with the disease.10,11,12,13 In CLL, too many blood stem cells in the bone marrow become abnormal lymphocytes and these abnormal cells have difficulty fighting infections.10 As the number of abnormal cells grows there is less room for healthy white blood cells, red blood cells and platelets.10 This could result in anaemia, infection and bleeding.10 B-cell receptor signalling through BTK is one of the essential growth pathways for CLL.

About AstraZeneca in haematology

Leveraging its strength in oncology, AstraZeneca has established haematology as one of four key oncology disease areas of focus. The Companys haematology franchise includes two US FDA-approved medicines and a robust global development programme for a broad portfolio of potential blood cancer treatments. Acerta Pharma serves as AstraZenecas haematology research and development arm. AstraZeneca partners with like-minded science-led companies to advance the discovery and development of therapies to address unmet need.

About AstraZeneca in oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly-growing portfolio of new medicines that has the potential to transform patients lives and the Companys future. With at least six new medicines to be launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers. In addition to AstraZenecas main capabilities, the Company is actively pursuing innovative partnerships and investments that accelerate the delivery of our strategy, as illustrated by the investment in Acerta Pharma in haematology.

By harnessing the power of four scientific platforms Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and, one day, eliminate cancer as a cause of death.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal and Metabolism, and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Twitter @AstraZeneca.

References

1. CALQUENCE (acalabrutinib) [prescribing information]. Wilmington, DE; AstraZeneca Pharmaceuticals LP; 2019.

2. Sharman JP, et al. ELEVATE TN: Phase 3 Study of Acalabrutinib Combined with Obinutuzumab (O) or Alone Vs O Plus Chlorambucil (Clb) in Patients (Pts) with Treatment-Naive Chronic Lymphocytic Leukemia (CLL). Abstract 31 at: American Society of Hematology 2019 Annual Meeting and Exposition. Available online. Accessed November 2019.

3. Data on File. REF-64711. AstraZeneca Pharmaceuticals LP, Wilmington, DE.

4. US Food and Drug Administration. Project Orbis. Available online. Accessed November 2019.

5. Wu J, Zhang M & Liu D. Acalabrutinib (ACP-196): a selective second-generation BTK inhibitor. J Hematol Oncol. 2016;9(21).

6. Khan Y & OBrien S. Acalabrutinib and its use in treatment of chronic lymphocytic leukemia. Future Oncol. 2018;15(6).

7. Byrd JC, et al. Acalabrutinib (ACP-196) in Relapsed Chronic Lymphocytic Leukemia. N Engl J Med. 2016; 374:323-332.

8. ClinicalTrials.gov. Elevate CLL TN: Study of Obinutuzumab + Chlorambucil, Acalabrutinib (ACP-196) + Obinutuzumab, and Acalabrutinib in Subjects With Previously Untreated CLL. NCT02475681. Available online. Accessed November 2019.

9. ClinicalTrials.gov. A Study of Acalabrutinib vs Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in R/R CLL. NCT02970318. Available online. Accessed November 2019.

10. National Cancer Institute. Chronic Lymphocytic Leukemia Treatment (PDQ)Patient Version. Available online. Accessed November 2019.

11. Global Burden of Disease Cancer Collaboration. Global, Regional, and National Cancer Incidence, Mortality, Years of Life Lost, Years Lived With Disability, and Disability-Adjusted Life-Years for 29 Cancer Groups, 1990 to 2016. JAMA Oncol. 2018;4(11):1553-1568.

12. American Cancer Society. Key Statistics for Chronic Lymphocytic Leukemia. Available online. Accessed November 2019.

13. Jain N, et al. Prevalence and Economic Burden of Chronic Lymphocytic Leukemia (CLL) in the Era of Oral Targeted Therapies. Blood. 2015;126:871.

SOURCE: AstraZeneca

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