Independent data from the PRESTIGIO Registry Study Group in Italy shows leronlimab inhibits multi-drug resistant HIV-1 viruses in Heavily Treatment-Experienced (HTE) patients

VANCOUVER, Washington, Nov. 18, 2019 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company), a late stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today that an abstract from the PRESTIGIO Registry Study Group showing that leronlimab was effective at inhibiting multi-drug resistant HIV-1 isolates from HTE patients was accepted for presentation at CROI. The HTE HIV-1-infected patients harbored documented 4-class resistances and were enrolled in the Italian PRESTIGIO Registry Study Group. The authors conclude that, in HTE patients with multi-drug resistance to HIV-1, all CCR5 tropic strains were fully susceptible to PRO 140.

PRESTIGIO is an Italian registry (http://www.registroprestigio.com) involving 40 clinical centers throughout Italy, coordinated by the IRCCS San Raffaele Hospital (Milan). The registry is performing medical research in a study involving HTE HIV-1-infected patients with a documented 4-class drug resistance (multi-drug resistance MDR), including novel treatment approaches.

This completely independent research study on clinical isolates from patients with documented 4-class drug resistances demonstrates that leronlimab may play a key role in patients with very limited therapeutic options, stated CytoDyn President and CEO, Nader Pourhassan, Ph.D. This is further support for our belief that leronlimab is positioned to change the treatment paradigm in HIV therapy, Dr. Pourhassan concluded.

This data, co-authored by Stefano Rusconi, M.D., et al., University of Milan, on behalf of the PRESTIGIO Registry Study Group, will be presented at the March 8-11, 2020 CROI meeting at the Hynes Convention Center, Boston, MA.

About Leronlimab (PRO 140)The U.S. Food and Drug Administration (FDA) has granted a "Fast Track" designation to CytoDyn for two potential indications of leronlimab for deadly diseases. The first as a combination therapy with highly active antiretroviral therapy (HAART) for HIV-infected patients, and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including non-alcoholic steatohepatitis (NASH). Leronlimab has successfully completed nine clinical trials in over 800 people, including meeting its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab can significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 plays a vital role in tumor invasion and metastasis. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019. CytoDyn is conducting additional research with leronlimab in the setting of oncology and NASH with plans to conduct further clinical studies when appropriate.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be important in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells. CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD. Blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted "orphan drug" designation to leronlimab for the prevention of GvHD.

About CytoDynCytoDyn is a biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a crucial role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH. CytoDyn has completed a Phase 3 pivotal trial with leronlimab in combination with standard anti-retroviral therapies in HIV-infected treatment-experienced patients. CytoDyn plans to seek FDA approval for leronlimab in combination therapy and plans to complete the filing of a Biologics License Application (BLA) in 2019 for that indication. CytoDyn is also conducting a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication, which, if successful, could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV with no reported drug-related serious adverse events (SAEs). Moreover, results from a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients. Some patients on leronlimab monotherapy have viral suppression for more than four years. CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and has received clearance to initiate a clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at http://www.cytodyn.com.

Forward-Looking StatementsThis press release contains certain forward-looking statements that involve risks, uncertainties, and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as "believes," "hopes," "intends," "estimates," "expects," "projects," "plans," "anticipates" and variations thereof, or the use of future tense, identify forward-looking statements but, their absence does not mean that a statement is not forward-looking. The Company's forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i)the sufficiency of the Companys cash position, (ii)the Companys ability to raise additional capital to fund its operations, (iii) the Companys ability to meet its debt obligations, if any, (iv)the Companys ability to enter into partnership or licensing arrangements with third parties, (v)the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (vi)the Companys ability to achieve approval of a marketable product, (vii)the design, implementation and conduct of the Companys clinical trials, (viii)the results of the Companys clinical trials, including the possibility of unfavorable clinical trial results, (ix)the market for, and marketability of, any product that is approved, (x)the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (xi)regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii)general economic and business conditions, (xiii)changes in foreign, political, and social conditions, and (xiv)various other matters, many of which are beyond the Companys control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form10-K, and any risk factors or cautionary statements included in any subsequent Form10-Q or Form8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CONTACTSInvestors: Nader Pourhassan, Ph.D.President & CEOnpourhassan@cytodyn.com

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CytoDyn Announces Acceptance of Leronlimab (PRO 140) Data for Presentation at the Conference on Retroviruses and Opportunistic Infections (CROI) in...

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The latest lifestyle, fashion and travel trends

He is one of the most googled names in beauty, and she, one of the most prominent figures in fashion.

It was therefore a fitting match for Victoria Beckham to join forces with Augustinus Bader the notoriously publicity-shy director of stem cell biology and cell technology at the University of Leipzig for her first foray in to skincare.

Bader became a household beauty name in February 2018, after the launch of his cult-product The Cream caused convulsions of desire to ripple throughout the beauty industry thanks to its ultra-hydrating and restorative qualities.

And so when looking for a scientific collaborator to join her on her endeavour in to skincare, it seemed a natural fit for the two to merge theircomplementingareas of expertise.

The Cell Rejuvenating Priming Moisturizer (Victoria Beckham Beauty)

Cue the result of the pairing: Victoria Beckham Beautys Cell Rejuvenating Priming Moisturizer.

The moisturiser is the new-and-improved iteration of the Morning Aura Primer Beckham launched as part of her collaboration with Este Lauder in 2016.

The product, which Beckham has re-developed with the help of 59-year-old Bader, is a multifunctional cream thatclaims to prime, impart a glow and also to repair.

Commenting on the collaborative beauty effort, Beckham took to her Instagram page to note: It has been a dream to develop, with Augustinus, a priming moisturizer that works to improve the health of my skin and gives that fresh, natural glow that I love.

Meanwhile Bader said: "It was an honour to collaborate with Victoria for her first Skin launch. I'm excited to share some of our skincare benefits in this product. It's the first product of its kind to care for your skin cells while also preparing your skin for makeup application."

A celebrity facialist has revealed VB's 9-step daily skincare routine

This marks the first skincare product 45-year-old Beckham has launched under her beauty line, which she debuted to critical-acclaim in September, alongside the brands co-founder, Sarah Creal.

Victoria Beckham Beauty has the tagline Luxury Performance, Clean Beauty, and is refusing to pigeonhole itself as just a beauty brand, instead referring to itself as clean beauty movement.

Cell Rejuvenating Priming Moisturizer costs 92 for 30ml and launches tomorrow exclusively at victoriabeckhambeauty.com and augustinusbader.com.

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Everything you need to know about Victoria Beckhams first skincare product launching tomorrow - Evening Standard

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Gallant Stem Cell Therapy For Dogs is one of the product companies to be featured on Shark Tank Season 11 Episode 8. The story behind the birth of Gallant Stem Cell Therapy For Dogs is pretty interesting. Here are some of the unknown facts about Gallant and its founders, Aaron Hirschhorn.

Aaron Hirschhorn is the founder and former-CEO of the popular dog-sitting marketplace DogVacay. Aaron is a noted entrepreneur with more than 20 years of experience in building companies and investing in them. DogVacay app was launched in 2013 and Aaron managed to raise $47 million from his erstwhile investors.

Aaron was the finalist in the Ernst & Young Entrepreneur of the Year Award 2016. In April 2017, Aarons DogVacay app merged with Rover.com and eventually went on to become a $1 billion pet services marketplace.

Trouble struck Aarons life when he suffered a massive back injury and was forced to undergo stem cell treatment which yielded amazing results to his surprise. Aaron, being an ardent dog lover wondered why this cutting-edge medical technology of stem cell transplants cannot be applied to dogs.

As a result, Gallant was born in the middle of 2018. According to Gallant, Your pups stem cells haveincredible healing power. Extract and store these powerful cells during your pets spay/neuter, so that you can unleash their potential when your best friend needs it most.

Ever since its inception, the mission of Gallant stem cell therapy is to help pets live a healthier life and make use of the epic technology of stem cell therapy in saving the lives of tons of dogs.

Dogs enter their senior years around 7 and begin feeling the effects of aging as early as 4! Traditional methods of treatment for injury and age-related conditions are expensive and can have harmful side effects. Stem cells are incredible natural healers. However, up to 99% of stem cells are lost over time due to aging. This forms the bottomline of Gallants business problem.

Gallant raised $7 million investment in August 2019.

https://gallant.com/

From the moment you entrust Gallant with your dogs stem cells, were actively invested in their long-term health and well-being. Working in tandem with you and your veterinarian, we will collect and store these powerful cells now, so down the road we can help to treat the most common health problems your dog may face. We will also update you on new and potentially life-changing treatments as they become available.

Pick your pups stem cell storage plan you dont have to have a spay/neuter procedure scheduled yet! You can always add that in later. Our proprietary process requires no additional training, so any veterinarian you trust to alter your dog is qualified. Ahead of your dogs spay/neuter, we will connect with your vet and send our collection kit directly to their office.

2. Collect

On the big day, we align with your vet before the procedure and arrange for a courier. During your dogs spay/neuter procedure, your veterinarian will take out the stem cell-rich reproductive tissue they would normally discard into the collection kit.

3. Preserve

Once the tissue is received by our scientists, we send confirmation to both you and your veterinarian. Your dogs tissue is first inspected for quality before isolating the stem cells. The stem cells are then counted and frozen in liquid nitrogen to preserve their potency in our secure, state-of-the-art laboratory. Once this process is complete, you and your veterinarian will be notified that your pets stem cells are safely stored. The cells are then monitored by our team to ensure they stay perfectly preserved.

4. Treat

Your pets stem cells are at the ready to be sent to your veterinarian if/when treatment is needed. Treatments are out-patient procedures and cost about $300. A stem cell procedure is not painful to your pet and does not require anesthesia to administer.

Gallants stem cell therapy is receiving a lot of exciting reviews online. The therapy has been successful in saving scores of dogs with conditions like osteoarthritis, skin conditions, chronic dry eye.

Gallant is offering a $395 off discount for using the code SHARKTANK

How did Gallant fare in Shark Tank Season 11? What did the Sharks have to tell about it? Did Gallant Get a Deal on Shark Tank? More information to be updated soon in this post.

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Shark Tank Season 11 Episode 8 Everything About Gallant Stem Cell Bank For Dogs As Seen on Shark Tank! Unknown Facts - TheNewsCrunch

Skin Stem Cells Comments Off on Shark Tank Season 11 Episode 8 Everything About Gallant Stem Cell Bank For Dogs As Seen on Shark Tank! Unknown Facts – TheNewsCrunch | November 18th, 2019

Global oncology drugs market was estimated to be US$ 119 billion in 2018 is expected to reach US$ 350.01 billion by 2027, growing at an estimated CAGR of 12.7% over the forecast period.

Cancer is a disease, which involves the abnormal growth of cells that results in the formation of a tumor. However benign tumors are not cancers. The abnormal tumor cells have the tendency to spread to other local tissues and may also spread to different parts of body through blood and lymphatic system. Different types of cancers such as lung cancer, colorectal, breast cancer, and others are predominant among the populace. Treatment of cancer depends upon the stages of the disease progression. Chemotherapy is majorly used in the earlier stages whereas other therapy options such as targeted therapy drugs, immunological therapy drugs are used in late stage.

Request For Sample Copy of This Report:https://www.absolutemarketsinsights.com/request_sample.php?id=273

The detailed research study provides qualitative and quantitative analysis of the global oncology drugs market. The market has been analyzed from demand as well as supply side. The geographical analysis done emphasizes on each of the major countries across North America, Europe, Asia Pacific, Middle East & Africa, and Latin America.

Key Findings of the Report:

Enquiry Before Buying This Report:https://www.absolutemarketsinsights.com/enquiry_before_buying.php?id=273

Key Market Segments of Oncology drugs market are:

By Indication

Oncology drugs Market By Treatment

Oncology drugs Market By Geography

For more information ask our experts@https://www.absolutemarketsinsights.com/reports/Oncology-Drugs-Market-2019-2027-273

About Absolute Markets Insights:Contact Us:Company: Absolute Markets InsightsContact Name: Shreyas TannaPhone: +91-740-024-2424Email id:sales@absolutemarketsinsights.comWebsite:https://www.absolutemarketsinsights.com

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Oncology drugs market is expected to grow at a CAGR of 12.7% over the forecast period owing to rising number of pipeline cell-therapy products, says...

Skin Stem Cells Comments Off on Oncology drugs market is expected to grow at a CAGR of 12.7% over the forecast period owing to rising number of pipeline cell-therapy products, says… | November 18th, 2019

Continuing its expansion efforts, Japans Fujifilmwill make a major investment in its U.S. gene therapy operation with plans for a $120 million addition to its facilities in Texas.

The company said its CDMO Fujifilm Diosynth Biotechnologies will add a building to its Dallas campus which will include6,000 square meters of new laboratories as well as eight new 500 / 2,000L single use bioreactors. A Fujifilm spokeswoman said the company intends to add 75 to 100 more scientists when the first phase of the new project is ready in 2021.

Fujifilm is aggressively pursuing growth strategies with both capital investment and in-house development of high-efficiency and high-productivity new technologies,the company said in a statement.

Striving for Zero in Quality & Manufacturing

Pharmaceutical and medical device manufacturers strive towards a culture of zero zero hazards, zero defects, and zero waste. This webinar will discuss the role that content management plays in pharmaceutical manufacturing to help companies reach the goal of zero in Quality and Manufacturing.

RELATED:Fujifilm pays Biogen nearly $1B for Denmark biologics site

The announcement comes shortly after the CDMO completed a deal to buy a biologics plant in Denmark from Biogen, taking on 800 employees. Fujifilm and Biogen also agreed the CDMO would provide Biogen with the drugs the Cambridge, Massachusetts-based biotech had been manufacturing at the site. That includes its multiple sclerosis drug Tysabri.

The Japanese company has been on a spending spree in the last couple of years. In addition the the recent deals, it paid about $800 million to buy a pair of cell culture media units from Japans JXTG Holdings. In January, Fujifilm said it would invest about $90 million to expand its biologics plant in Morrisville, North Carolina, and the company is ramping up its induced pluripotent stem cell technologies for its own pipeline of regenerative drugs and intendsto manufacture iPS cells for others.

The company says it expects the CDMO business to generate nearly a $1 billion by the end of fiscal year 2021, ending March 2022.

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Fujifilm adding $120M facility to its gene therapy operations in U.S. - FiercePharma

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As per a recent study, Human heart muscle cells show some changes in the way they function in space, although they operate normally within 10 to 12 days after returning to the Earth, as per the new study. The research examined the cell-level cardiac function and gene expression in human heart cells cultured aboard the International Space Station (ISS) for 5.5 weeks. Coverage to microgravity altered the expression of thousands of genes, but often standard patterns of gene expression reappeared within ten days after returning to the Earth, the researchers said. Our study is novel because it is the first to use human induced pluripotent stem cells to study the effects of spaceflight on human heart function, as stated by Joseph C Wu of Stanford University School of Medicine in the US.

Past studies have revealed that spaceflight induces physiological changes in cardiac function, which includes lowered arterial pressure, reduced heart rate, and increased cardiac output. On the other hand, to date, most cardiovascular microgravity physiology research has been conducted either in non-human models or at tissue, organ, or systemic levels. Comparatively, little is known to date about the role of microgravity in influencing human cardiac function at the cellular level. Wu and his collaborators examined human-induced pluripotent stem cell-derived cardiomyocytes (hiPSC-CMs). They removed hiPSC lines from three individuals by reprogramming blood cells and then differentiated them into hiPSC-CMs. Upon returning to Earth, space-flown hiPSC-CMs showed normal morphology and structure. However, they did adapt through modification of their beating pattern and calcium recycling pattern, the researchers explained. They also conducted RNA sequencing of hiPSC-CMs harvested at around 4 weeks aboard the ISS, and 10 to 12 days after returning to Earth.

These results showed that 2,647 genes were differentially expressed among flight, post-flight & ground control samples, the researchers stated. Gene pathways associated with mitochondrial function were expressed more in space-flown hiPSC-CMs, they further said. Comparing the samples revealed that hiPSC-CMs implement a unique gene expression pattern during spaceflight, which reverts to one that is very similar to ground side controls upon return to regular gravity, as per the researchers. These studies may offer insight into cellular mechanisms that could improve astronaut health during long-duration spaceflight, or potentially lay the foundation for latest insights into enhancing heart health on Earth, he further added.

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Human heart cells behave differently in space - SellRegular

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The following are the top rated Healthcare stocks according to Validea's Small-Cap Growth Investor model based on the published strategy of Motley Fool. This strategy looks for small cap growth stocks with solid fundamentals and strong price performance.

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Company Description: Zynex, Inc. operates through the Electrotherapy and Pain Management Products segment. The Company conducts its business through its subsidiaries and the operating subsidiary is Zynex Medical, Inc. (ZMI). Its other subsidiaries include Zynex Monitoring Solutions, Inc. (ZMS) and Zynex Europe, ApS (ZEU). ZMI designs, manufactures and markets medical devices that treat chronic and acute pain, as well as activate and exercise muscles for rehabilitative purposes with electrical stimulation. ZMS is in the process of developing its blood volume monitoring product for non-invasive cardiac monitoring. ZEU intends to focus on sales and marketing its products within the international marketplace, upon receipt of necessary regulatory approvals. It markets and sells Zynex-manufactured products and distributes private labeled products. Its products include NexWave, NeuroMove, InWave, Electrodes and Batteries. ZMI devices are intended for pain management to reduce reliance on drugs and medications.

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Company Description: Inmode Ltd is an Israel-based company. It designs, develops, manufactures and commercializes energy-based, minimally-invasive surgical aesthetic and medical treatment solutions. The Company's proprietary technologies are used by physicians to remodel subdermal adipose, or fatty, tissue in a variety of procedures including fat reduction with simultaneous skin tightening, face and body contouring and ablative skin rejuvenation treatments. Its products target a wide array of procedures including simultaneous fat killing and skin tightening, permanent hair reduction, skin appearance and texture, among others. The Company's products may be used on a variety of body parts, including the face, neck, abdomen, upper arms, thighs and intimate feminine regions. It owns six product platforms: BodyTite, Optimas, Votiva, Contoura, Triton and EmbraceRF. All are market and sell traditionally to plastic and facial surgeons, aesthetic surgeons and dermatologists, among others.

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Company Description: BioLife Solutions, Inc. (BioLife) is engaged in the developing, manufacturing and marketing a portfolio of biopreservation tools and services for cells, tissues and organs, including clinical grade cell and tissue hypothermic storage and cryopreservation freeze media and a related cloud hosted biologistics cold chain management application for shippers. The Company's product offerings include hypothermic storage and cryopreservation freeze media products for cells, tissues, and organs; generic blood stem cell freezing and cell thawing media products; custom product formulation and custom packaging services; cold chain logistics services incorporating precision thermal packaging products and cloud-hosted Web applications, and contract aseptic manufacturing formulation, fill and finish services of liquid media products. Its products include HypoThermosol FRS, CryoStor, BloodStor, Cell Thawing Media, PrepaStor and biologistex cold-chain management service.

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CHINA BIOLOGIC PRODUCTS HOLDINGS INC (CBPO) is a mid-cap growth stock in the Biotechnology & Drugs industry. The rating according to our strategy based on Motley Fool is 72% based on the firms underlying fundamentals and the stocks valuation. A score of 80% or above typically indicates that the strategy has some interest in the stock and a score above 90% typically indicates strong interest.

Company Description: China Biologic Products Holdings, Inc. is a biopharmaceutical company. The Company is principally engaged in the research, development, manufacturing and sales of human plasma-based biopharmaceutical products in China. It operates through the manufacture and sales of human plasma products segment. China Biologic has a product portfolio with over 20 various dosage forms of plasma products and other biopharmaceutical products across nine categories.The Company's products include human albumin, human immunoglobulin, immunoglobulin for intravenous injection (IVIG), human hepatitis B immunoglobulin, human rabies immunoglobulin, human tetanus immunoglobulin, placenta polypeptide, Factor VIII and human prothrombin complex concentrate (PCC).

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ADVERUM BIOTECHNOLOGIES INC (ADVM) is a small-cap growth stock in the Biotechnology & Drugs industry. The rating according to our strategy based on Motley Fool is 69% based on the firms underlying fundamentals and the stocks valuation. A score of 80% or above typically indicates that the strategy has some interest in the stock and a score above 90% typically indicates strong interest.

Company Description: Adverum Biotechnologies, Inc. is a clinical-stage gene therapy company targeting unmet medical needs in serious rare and ocular diseases. Adverum has a robust pipeline that includes product candidates designed to treat rare diseases alpha-1 antitrypsin (A1AT) deficiency and hereditary angioedema (HAE) as well as wet age-related macular degeneration (wAMD). Leveraging a next-generation adeno-associated virus (AAV)-based directed evolution platform, Adverum generates product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. It has collaboration agreements with Regeneron Pharmaceuticals to research, develop, and commercialize gene therapy products for ophthalmic diseases and Editas Medicine to explore the delivery of genome editing medicines for the treatment of inherited retinal diseases. Its core capabilities include clinical development and in-house manufacturing, specifically in process development and assay development.

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Press release content from ACCESSWIRE. The AP news staff was not involved in its creation.

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CARLSBAD, CA / ACCESSWIRE / November 15, 2019 / International Stem Cell Corporation (OTCQB:ISCO) ( http://www.internationalstemcell.com ) (ISCO or the Company), a California-based clinical stage biotechnology company developing novel stem cell-based therapies and biomedical products, today announced operating results for the three and nine months ended September 30, 2019.

As we mentioned before we completed the enrollment of the Phase I Parkinsons disease clinical trial and currently involved in reorganizing our revenue-generating subsidiaries. We expect that we will see positive results of this reorganization next year. - commented Andrey Semechkin, PhD., CEO and Co-Chairman of ISCO.

Year-to-Date Financial Highlights

About International Stem Cell Corporation

International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCOs core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology ( http://www.lifelinecelltech.com ), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at http://www.internationalstemcell.com.

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Statements pertaining to anticipated developments, expected results of clinical studies, progress of research and development, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as will, believes, plans, anticipates, expects, estimates,) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the companys business, particularly those mentioned in the cautionary statements found in the companys Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.

International Stem Cell Corporation and Subsidiaries Condensed Consolidated Balance Sheets (in thousands, except share data and par value) (Unaudited)

Assets

Cash

Accounts receivable, net

Inventory, net

Prepaid expenses and other current assets

Total current assets

Non-current inventory

Property and equipment, net

Intangible assets, net

Right-of-use assets

Deposits and other assets

Total assets

Liabilities, Redeemable Convertible Preferred Stock, and Stockholders' Equity (Deficit)

Accounts payable

Accrued liabilities

Operating lease liabilities, current

Related party payable

Advances

Warrant liability

Total current liabilities

Long-term deferred rent

Operating lease liabilities, net of current portion

Total liabilities

Commitments and Contingencies

Series D Redeemable Convertible Preferred stock, $0.001 par value, 50 shares authorized, 43 issued and

outstanding, with liquidation preference of $4,300 at September 30, 2019

Stockholders' Equity (Deficit)

Series B Convertible Preferred stock, $0.001 par value, 5,000,000 shares authorized, 250,000

issued and outstanding, with liquidation preferences of $423 and $411 at September 30, 2019 and

December 31, 2018

Series D Convertible Preferred stock, $0.001 par value, 50 shares authorized, 43 issued and

outstanding, with liquidation preference of $4,300 at December 31, 2018

Series G Convertible Preferred stock, $0.001 par value, 5,000,000 shares authorized, issued and

outstanding, with liquidation preference of $5,000 at September 30, 2019 and December 31, 2018

Series I-1 Convertible Preferred stock, $0.001 par value, 2,000 shares authorized, 814 issued and

outstanding, with liquidation preferences of $814 at September 30, 2019 and December 31, 2018

Series I-2 Convertible Preferred stock, $0.001 par value, 4,310 shares authorized,

issued and outstanding with liquidation preference of $4,310 at September 30, 2019 and December 31, 2018

Common stock, $0.001 par value, 120,000,000 shares authorized, 7,533,083 and 6,933,861 shares

issued and outstanding at September 30, 2019 and December 31, 2018

Additional paid-in capital

Accumulated deficit

Total stockholders' equity (deficit)

Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit)

International Stem Cell Corporation and Subsidiaries Condensed Consolidated Statements of Operations (in thousands, except per share data) (Unaudited)

Revenues

Product sales

Total revenues

Expenses

Cost of sales

Research and development

Selling and marketing

General and administrative

Total expenses

Loss from operations

Other income (expense)

Change in fair value of warrant liability

Interest expense

Miscellaneous income

Total other income (expense), net

Net income (loss)

Net income (loss) applicable to common stockholders

Net income (loss) per common share-basic

Net income (loss) per common share-diluted

Weighted average shares-basic

Weighted average shares-diluted

Contacts:

International Stem Cell Corporation

Russell A. Kern, PhD

Phone: 760-940-6383

Email:

SOURCE: International Stem Cell CORP

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International Stem Cell Corporation Announces Financial Results for the Three and Nine-Months ended September 30, 2019 - Associated Press

Skin Stem Cells Comments Off on International Stem Cell Corporation Announces Financial Results for the Three and Nine-Months ended September 30, 2019 – Associated Press | November 17th, 2019

This product gave our columnist her best-ever skin. Read on

The Sunday Times,November 17 2019, 12:01am

This is one of those ding-ding-ding with a knife on a glass occasions. Obviously I review products I love and recommend from the heart every week, but equally obviously, not every single one is necessarily a life-changer. My personal list of the skincare products I would never again be without is not especially long. However, I currently have the best skin I have ever had in my entire life, including during periods when I paid much more attention to it and had regular facials, microdermabrasions, peels and so on. Hence the glass dinging.

Decree is another line by a doctor, in this case a Dr AJ Sturnham, who is a GP with a special interest in dermatology and aesthetics. The idea is that the line

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India Knight on the facial serum that transformed her skin - The Times

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Victoria Beckham has called on scientist Augustinus Bader, who created a 205 face cream that celebrities rave about, to develop a hi-tech skincare product that claims to supercharge your complexion

The Sunday Times,November 17 2019, 12:01am

Do you remember when Victoria Beckham launched a product called Morning Aura? It was part of her first make-up collection for Este Lauder in 2016 and sent fans into a frenzy, selling out in record time.

In September, VB launched her own beauty brand, Victoria Beckham Beauty, with the help of Sarah Creal the former head of global make-up marketing and product development at Este Lauder, and the woman who worked closely with her on that first beauty collection. And now they are returning to Morning Aura, but better, Beckham says, when we speak on the phone.

But this isnt the usual new-bottle-same-formula reboot: she has teamed up with Professor Skincare himself, Augustinus Bader, one of the most googled names in beauty. Bader shot

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Victoria Beckham on testing products on David and Harper's concerns for sustainability as she launches new skincare - The Times

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BIORESTORATIVE THERAPIES, INC. (OTCMKTS:BRTX) Files An 8-K Submission of Matters to a Vote of Security HoldersItem 5.07 Submission of Matters to a Vote of Security Holders.

On November 13, 2019, BioRestorative Therapies, Inc. (the Company) held a Special Meeting of Stockholders (the Special Meeting). The following is a listing of the votes cast for and against, as well as abstentions, with respect to the matters voted upon at the Special Meeting. At the Special Meeting, the Companys stockholders (i) approved an amendment to the Companys Certificate of Incorporation to increase the number of shares of common stock authorized to be issued by the Company from 150,000,000 to 300,000,000, (ii) approved amendments to the Certificate of Incorporation of the Company, and authorized the Board of Directors of the Company to select and file one such amendment, to effect a reverse stock split of the Companys common stock at a ratio of not less than 1-for-2 and not more than 1-for-100, with the Board of Directors of the Company having the discretion as to whether or not the reverse stock split is to be effected, and with the exact ratio of any reverse stock split to be set at a whole number within the above range as determined by the Companys Board of Directors in its discretion (the Reverse Stock Split Proposal), which Reverse Stock Split Proposal revises the reverse stock split ratio approved by the Companys stockholders on May 30, 2019 and (iii) authorized the Board of Directors of the Company, in its discretion, to reduce the number of shares of common stock authorized to be issued by the Company in proportion to the percentage decrease in the number of outstanding shares of common stock resulting from the reverse split (or a lesser decrease in authorized shares of common stock as determined by the Companys Board of Directors in its discretion).

(d) Exhibits.

3.1 Certificate of Amendment of Certificate of Incorporation of the Company

About BIORESTORATIVE THERAPIES, INC. (OTCMKTS:BRTX)

BioRestorative Therapies, Inc. develops therapeutic products and medical therapies using cell and tissue protocols, involving adult (non-embryonic) stem cells. The Company offers human and plant stem cell derived cosmetic and skin care products. Its programs relate to the treatment of disc/spine disease and metabolic disorders and include Disc/Spine Program (brtxDISC) and Metabolic Program (ThermoStem). Its curved needle device (CND) is a needle system with a curved inner cannula to allow access to difficult-to-locate regions for the delivery or removal of fluids and other substances. The CND is intended to deliver stem cells and/or other therapeutic products or material to the interior of a human intervertebral disc, the spine region, or other areas of the body. The device relies on the use of pre-curved nested cannulae that allows the cells or material to be deposited in the posterior and lateral aspects of the disc to which direct access is not possible due to outlying structures.

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BIORESTORATIVE THERAPIES, INC. (OTCMKTS:BRTX) Files An 8-K Submission of Matters to a Vote of Security Holders - Market Exclusive

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If you're a science fiction enthusiast, then chances are, you already have a clear picture of what the future holds for humanity. Be it space travel, robots, or some weird means of extradimensional communication, sci-fi films have given us a glimpse of future technologies and events one way or another. In fact, each decade, sci-fi movies' futuristic predictions keep growing more accurate.

RELATED:Ranked: 10 Scariest '90s Sci-Fi Movie Monsters

By the 2000s, some of them have already gotten a little too prophetic and hauntingly precise. Needless to say, they are definitely worth watching for their predictions alone. So, we present you with 10 sci-fi films from the 2000s that got the future right in one or more aspects. These masterpieces have not only entertained us but also prepared us for the coming years.

Crime is one of the favorite subject matters of sci-fi media because it allows for creative twists in the otherwise exhaustive genre.Minority Report(2002)and its Pre-crime system is a good example. It's basically a prediction of who will commit crimes or become criminals based on their psychological background and allows authorities to stop crim before they even happen.

As it turns out, Pre-crime is not entirely far-fetched as a law-enforcement system. Japan (who'd have thought?) has something quite similar but less advanced, from A.I. cameras that can detect shoplifters before they do the deed to a "crime analytics" system which predicts where crime will happen. Their police force only began using such tech during this decade.

A.I. Artificial Intelligenceis one of the most philosophical sci-fi films of all time and doesn't shy away from questioning the nature of humanity and what makes us human. In that regard, it paints a rather familiar scene of the future where humans are using robots for prostitution.

RELATED:10 Sci-Fi Movies That Will Make You Think As Much As Inception

In the film, this becomes apparent as soon as Jude Law's robot character, Gigolo Joe, gets introduced. You can probably guess what he does for a living. You'll either be pleased or weirded out to know that bots like Gigolo Joe exist today. There are now official sex dolls who can talk and even give compliments, there's even a brothel full of dolls. Who knows what a few more years of robotics and primal human urges can bring?

Many things inWall-Efrom 2008 are now starting to become true today. Well, perhaps they were already true back then, but they're definitely becoming a lot more apparent today. We're talking about the Earth becoming a giant landfill, advertisements everywhere there's a breathing human being, drivable chairs, and of course, rising obesity rates.

Oh, there's also the fact that certain Governments and even corporations are most likely already looking for a way out of Earth (andto Mars) before things get too messy. In a way,Wall-Eis already happening and we really should be more alarmed now, shouldn't we?

You've probably never heard ofThe Islandbefore and that's due to the film not having the best marketing. In any case,The Islandis about a man who struggles to fit in at an isolated compound he lives in. He soon discovers that everyone was a clone of someone else and that they were merely being harvested for their organs to treat the social elite.

RELATED:10 Best Sci-Fi Movies of the '90s, According to IMDb

Surprise, surprise, there have been scientific and medical breakthroughs about the exact same thing. Scientists have been able to use human cloning to create stem cells that were used to regenerate the skin cells of a 75-year-old man. Further studies and developments are needed and we're still stuck with experimenting on pigs at the moment.

I, Robot was a cinematic flop but was still impressive enough to get its own meme culture more than a decade later. Critics often hailed it as a rip-off ofBlade Runner but in hindsight,I, Robot was a little more radical in how it gave us a picture of future societies. In the film, corporations ruled everything, with automation and A.I. replacing many jobs, making lots of humans unemployed.

Sadly, robots might actually soon take our jobs. We're not just referring to blue-collar work being replaced by heavy machinery; A.I. is learning fast and might take over some administrative jobs and basically everything that requires routine and repetition. It's time to re-evaluate your career options.

It's more romance than sci-fi butEternal Sunshine of the Spotless Mindhas that one plot device (metaphorical or not) which makes quality as science fiction. That would be the memory deletion procedure which a mad neuro-surgeon in the film invented. It allows him to delete people's memories of other people, basically selective amnesia with consent; the first application the filmmakers thought for that technology was moving on from a heartbreak.

RELATED:10 Worst Sci-Fi Movies, According To IMDb

Turns out, there are more practical uses for such a procedure in the real world. Scientists have successfully erased some traumatic memories for mice back in 2013 by locating a gene. They do hope to apply the same procedure to ease the mental pain of patients with post-traumatic stress disorders (PTSD), rather than just for couples with breakup difficulties.

Unfortunately,The Matrixwas released back in 1999, which makes it a year short of qualifying as a 2000s movie. Still, it had sequels and an animated anthology spin-off calledThe Animatrixthat basically explored the same ideas. One notable technology thatThe Matrixfranchiseprophesized (see what we did there?) is virtual reality.

The protagonists ofThe Matrixfranchise basically plug themselves into computers to sort of act as viruses that can bring down their machine enemies. To an extent, we do have this tech today in the form of VR headsets. It's not as immersive as sticking a huge needle into your spine, of course.

Marvel'sIron Manback in 2008 kicked off many great and influential things that we enjoy today and among those is a rekindled interest in robotics and military engineering. Apart from Robert Downey Jr. as Tony Stark, the biggest star inIron Manwas his self-sustaining and relatively compact armor; it's basically the equivalent of a whole country's army controlled by one man.

RELATED:10 90s Sci-Fi Masterpieces Youve Probably Never Seen

We don't have anything that advanced today; it's practically impossible at the moment with our limited resources and lack of further frontal lobe development but the U.S. Army is trying nonetheless with its exo-suit. These allow soldiers a better physical edge on the battlefield. They did try to re-create something more similar to the Iron Man suit but failed and ended up wasting millions of dollars.

The idea of visiting, recording, and manipulating dreams was popularized in Hollywood by films likeInception; however,Inception's primary inspiration was a Japanese anime film calledPaprika(2006), which also explored the same concept of entering, viewing, and interfering with dreams.

These days, such a feat is no longer limited to daydreaming; in 2011, a team of scientists at UC Berkeley was able to view someone else's dream. The scientists recordedthe subjects'brain activity and then translated the whole thing into a video. There were also scientists in Kyoto, Japan who managed to predict another person's dream into a picture which was 60 percent accurate. No more forgetting your dreams sooner or later.

You're probably tired of seeingChildren of Menin movie lists over and over again but it can't be helped, it's such a revelatory masterpiece that we can learn a lot from it. It's more modern dystopia than sci-fi, meaning most of what the film foresaw are political and socio-economic struggles similar to what we're experiencing today.

Apart from the rapidly declining birth rate which is happening to a certain country today,Children of Menalso painted a picture of a disturbing immigration crisis where people of wartorn countries are rushing like animals to the only countries with functioning governments left in the world. Oh, and resources are also in decline and everyone's out for themselves.Sounds eerily familiar.

NEXT:10 Times 90s Sci-Fi Movies Predicted The Future

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10 Times 2000s Sci-Fi Movies Predicted The Future | ScreenRant - Screen Rant

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ANI | Updated: Nov 16, 2019 17:52 IST

Washington D.C. [USA], Nov 16 (ANI): Researchers have developed a breakthrough cell therapy to improve memory and prevent seizures in mice following traumatic brain injury.The study -- 'Transplanted interneurons improve memory precision after traumatic brain injury' -- was published in the journal of 'Nature Communications.'Traumatic brain injuries (TBI) affect two million Americans each year and cause cell death and inflammation in the brain. People, who experience a head injury often, suffer from lifelong memory loss and can develop epilepsy.In the study, the team transplanted embryonic progenitor cells capable of generating inhibitory interneurons, a specific type of nerve cell that controls the activity of brain circuits, into the brains of mice with traumatic brain injury. They targeted the hippocampus, a brain region responsible for learning and memory.The researchers have discovered that the transplanted neurons migrated into the injury where they formed new connections with the injured brain cells and thrived long term.Within a month after treatment, the mice showed signs of memory improvement such as being able to tell the difference between a box where they had an unpleasant experience from one where they did not.They were able to do this just as well as mice that never had a brain injury. The cell transplants also prevented the mice from developing epilepsy, which affected more than half of the mice who were not treated with new interneurons."Inhibitory neurons are critically involved in many aspects of memory, and they are extremely vulnerable to dying after a brain injury," said Robert Hunt, PhD, assistant professor of anatomy and neurobiology at UCI School of Medicine, who led the study."While we cannot stop interneurons from dying, it was exciting to find that we can replace them and rebuild their circuits," added Hunt.To further test their observations, Hunt and his team silenced the transplanted neurons with a drug, which caused the memory problems to return."It was exciting to see the animals' memory problems come back after we silenced the transplanted cells because it showed that the new neurons really were the reason for the memory improvement," said Bingyao Zhu, a junior specialist and first author of the study.Currently, there are no treatments for people who experience a head injury. If the results in mice can be replicated in humans, it could have a tremendous impact on patients. The next step is to create interneurons from human stem cells."So far, nobody has been able to convincingly create the same types of interneurons from human pluripotent stem cells," Hunt said. "But I think we're close to being able to do this." (ANI)

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New cell therapy improves memory and stops seizures following TBI: Study - ANI News

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A 25-year-old Redding, Connecticut woman meets the Arizona man who was battling deadly Acute Lymphoblastic Leukemia (ALL) until she saved his life by donating her bone marrow.

Jennie Bunce joined Gift of Life Marrow Registry through a sorority swab drive at North Carolinas High Point University in 2016. "I can remember being like 13 or 14 years old during some school bucket list project. On there was save a life and I got to cross it off so thats pretty cool."

Her life-saving match-- 33-year-old father of six from Mesa, Mark Roser. Roser learned he had ALL after breaking a hip and feeling increasingly weak in 2018.

He needed a bone marrow transplant to survive. He says, "When they discovered it, 94% of my blood cells basically contaminated, so I was really at the final deadline."

Gift of Life Marrow Registry matched the Jennie to Mark with months.

The pair met for the first time at Boca Oyster Bar in Bridgeport in October. Mark says, " I feel great. Im much more positive between work and family. My priorities have completely changed. Time with the kids, time with my wife, just being there for them instead of working so much... I treasure every moment with them now."

According to the gift of Life marrow registry website: "Blood cancer is an umbrella term for cancers that affect the blood, bone marrow and lymphatic system. In most blood cancers, normal blood cell development is interrupted by uncontrolled growth of abnormal blood cells. The abnormal blood cells can prevent blood from fighting off infection or preventing uncontrolled bleeding.

Unfortunately, blood cancer can strike any one of us at any time. Approximately every three minutes, a child or adult in the United States is diagnosed with a type of blood cancer. Thats 360 people a day, 130,000 people a year.

There are three main types of blood cancers: Leukemia, cancer that is found in your blood and bone marrow; Lymphoma, blood cancer that affects the lymphatic system; and Myeloma, blood cancer that specifically targets your plasma cells.

For many, there is hope of a cure through a bone marrow or peripheral blood stem cell transplant. Today, transplantation, of healthy stem cells donated by related and unrelated volunteers, offers hope to many patients suffering from these sometimes deadly diseases.

Advances in transplantation have made this procedure a reality for thousands who are alive today because a stranger gave them the Gift of Life!."

check out: https://www.giftoflife.org to learn more and even register for a swab kit and become a donor yourself.

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Redding woman donates bone marrow, saves life of a father - FOX61 Hartford

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Illustration by Adam De Souza

First Person is a daily personal piece submitted by readers. Have a story to tell? See our guidelines at tgam.ca/essayguide.

A few days after my stem cell transplant this year, a young cleaner entered my hospital room to disinfect and swab. Broad faced and friendly, she saw me lying in bed reading a book.

Do you like reading, she asked? Well, I have the book for you. It is called Fifty Shades of Grey. Its porno!

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That last part was whispered behind a cupped hand, as she grinned and then giggled. For good measure, she also recommended the teen vampire series Twilight.

Once shed left I laughed out loud in a way I hadnt done for days, weeks in fact. When you have cancer, these moments are golden.

Over the last year I have spent months in hospitals, being infused with chemotherapy that laid me low and then undergoing a risky transplant of stem cells from a heroic unknown donor. During this long period of remission and recovery, I have valued every opportunity to smile, to breathe and to feel hope. Much of this sense of being fully alive has come from the kindness of others.

The transplant had made me feel very sick and there was a point at which I was terrified of dying. I asked the hospital staff for a spiritual adviser and the next day a Buddhist monk came to visit me. I didnt expect this, but his calm face and compassionate manner brought me peace. He read me poems for meditation, encouraged deep breathing, and assured me that all emotions in illness are human expressions of identity and not to be judged or feared. His gentleness was echoed two days later, when a nurse with the loveliest face I had ever seen knelt down next to my bed, held my hand, and reassured me I would be okay.

Day by day, my son, his girlfriend, and my husband encouraged and supported me, too, even when I could barely hold up my head or speak without tears. My 21-year-old son sat with me through many painful procedures, setting his phone to play Bachs Brandenburg Concertos, squeezing my hand, looking into my face, loving me and giving me strength I didnt think I had.

I was diagnosed with acute myeloid leukemia in February 2019; before that fateful month I was a modern German historian teaching university students on the Weimar Republic, Nazism and the Holocaust. There were days when I had wept and raged with my students over the historical accounts of Nazi inhumanity, barbarity and chilling callousness inflicted upon innocent civilians, especially the Jews. I have often questioned whether human nature is fundamentally selfish, violent and nasty. Right now, in this world of hateful populism and climate devastation, I ask these questions even more. But since I became sick, the kindness, indeed the goodness, of other people has been a constant companion to me. I have been overwhelmed by the extraordinary outpouring of support and concern from so many. Compassion, care, affection, hope all have been expressed to me by family, friends, students and colleagues. Blood drives were organized in my name, and students asked me if they could be tested as a possible bone-marrow donor. My sister (who hates medical procedures) underwent several tests to see if she could be a sibling transplant. One colleague even offered me the umbilical blood he had saved from his three children. (Ultimately the hospital found a donor from an international registry.)

Friends and family kept in touch or visited despite the long drives to the two hospitals where I received treatment. Two of my girlfriends texted me every day, sending love, inspiration and photos of flowers. From other well-wishers I received quilts and artwork and shawls, books and lotion and lip balm. I read notes and e-mails that told me I was not alone, that love surrounded me and would lift me up. Prayers were said for me in Protestant, Catholic, Unitarian, Muslim and Jewish places of worship. Students sent me good luck charms, including a chemo bear (it worked! I went into remission). Money was donated in a go-fund-me campaign to help with the costs of travel and accommodation to cancer centres. Strangers (friends of friends) offered their homes at the times when we couldnt find accommodation. Delicious meals were dropped off at my home or brought to the hospitals: lentil soups, macaroni and cheese, banana bread and smoothies, all preventing me from having to imbibe those horrible meal-replacement drinks or the cafeteria food. Cancer patients came to see me and shared their experiences and wisdom. A quietly stoic man in his 40s with Stage 4 colorectal cancer expressed hope in the advances in cancer treatment; another inspirational friend with breast cancer revealed she had undergone over 100 chemo treatments and still managed to propel her bike in the annual Ride to Conquer Cancer. Other leukemia patients in my wards became friends and sources of enormous support. My sister-in-law, a liver transplant survivor, understood my physical and emotional pain and talked me through several hard times. On the stranger than fiction level, old boyfriends and ex-friends reappeared, expressing their love and sending me cards or messages that brought tears to my eyes. At the same time high-school and university pals from my ancient past got in touch and told me to hang in there!

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I got through the worst days because of the superb doctors and nurses, the donor who gave her or his stem cells, and our excellent health-care system. But I also made it this far because I did not feel alone. I was constantly reminded that I am loved and that I have so much to live for. In the arduous world of my cancer treatment, the face of compassion has appeared so many times and in such beautiful ways that I now place much more faith in the goodness of human nature because I have seen that many of us will care for each other, especially in hard times.

I may not decide to read Fifty Shades of Grey, but I love that this young woman wanted to suggest something to make me forget the cancer and feel better. And, really, because of her and the support that surrounded me, I did.

Carolyn Kay lives in Peterborough, Ont.

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Im grateful for the kindness of strangers in my cancer recovery - The Globe and Mail

Bone Marrow Stem Cells Comments Off on Im grateful for the kindness of strangers in my cancer recovery – The Globe and Mail | November 15th, 2019

SHANGHAI and SUZHOU, China, Nov. 15, 2019 /PRNewswire/ --Gracell Biotechnologies Co., Ltd. ("Gracell"), a clinical-stage immune cell therapy company, today announced five presentations to be delivered at the upcoming American Society of Hematology (ASH) Annual Meeting in Orlando, Florida, held from December 7-10.

The presentations centre on Gracell's breakthrough FasTCARtechnology, and other two platform technology in four product categories used in the treatment of hematological malignancies, each with well-defined objectives, including:

The four product candidates are currently being studied in ongoing phase I clinical trials conducted by Gracell, Hebei Yanda Lu Daopei Hospital, and Xinqiao Hospital of AMU, and six other hospitals nationwide in China.

"These clinical studies demonstrated Gracell's product development strategy and strong capabilities to bring multiple novel therapies through clinical investigations," said Dr. William CAO, CEO of Gracell. "These invaluable data provides guidance for and enhance our confidence in pipeline selection."

Oral presentations:

A Feasibility and Safety Study of a New CD19-Directed Fast CAR-T Therapy for Refractory and Relapsed B cell Acute Lymphoblastic LeukemiaAbstract #825Session Name: 612. Acute Lymphoblastic Leukemia: Clinical Studies: Therapeutics StrategiesPresenter: Peihua Lu, M.D., Hebei Yanda Lu Daopei HospitalLocation: Orange County Convention Center, Tangerine 1 (WF1), Level 2Time: 5:00 pm, Monday, December 9, 2019https://ash.confex.com/ash/2019/webprogram/Paper121751.html

Anti-CD19/CD22 Dual CAR-T Therapy for Refractory and Relapsed B-Cell Acute Lymphoblastic LeukemiaAbstract #284Session Name: 612. Acute Lymphoblastic Leukemia: Clinical Studies: Novel TherapiesPresenter: Peihua Lu, M.D., Hebei Yanda Lu Daopei HospitalLocation: Orange County Convention Center, W224, Level 2Time: 4:15pm, Saturday, December 7, 2019https://ash.confex.com/ash/2019/webprogram/Paper126429.html

Poster presentations:

CD19-Directed Fast CART Therapy for Relapsed/Refractory Acute Lymphoblastic Leukemia: From Bench to BedsideAbstract #1340Session Name: 614. Acute Lymphoblastic Leukemia: Therapy, excluding Transplantation: Poster IPresenter: Cheng Zhang, M.D., Xinqiao Hospital of AMULocation: Orange County Convention Center, Hall B, Level 25:30-7:30 pm, Saturday, December 7, 2019https://ash.confex.com/ash/2019/webprogram/Paper128006.html

A Bcma and CD19 Bispecific CAR-T for Relapsed and Refractory Multiple MyelomaAbstract # 3147Session Name: 653. Myeloma: Therapy, excluding Transplantation: Poster IIPresenter: Hua Zhang, PhD., Gracell Biotechnology Ltd., Shanghai, China, Shanghai, ChinaLocation: Orange County Convention Center, Hall B, Level 26:00 PM-8:00 pm, Sunday, December 8, 2019https://ash.confex.com/ash/2019/webprogram/Paper131056.html

Role of Donor-Derived CD19.CAR-T Cells in Treating Patients That Relapsed after Allogeneic Hematopoietic Stem Cell TransplantationAbstract #4561Session Name: 723. Clinical Allogeneic and Autologous Transplantation: Late Complications and Approaches to Disease Recurrence: Poster IIIPresenter: Cheng Zhang, M.D., Xinqiao Hospital of AMULocation: Orange County Convention Center, Hall B, Level 26:00-8:00 pm, Monday, December 9, 2019https://ash.confex.com/ash/2019/webprogram/Paper128262.html

About FasT CAR-19

FasT CAR-19, or GC007F, is an investigational CD19-targeted CAR-T cell therapy for adolescent and adult patients with refractory or relapsed B-ALL, as well as aggressive non-Hodgkin lymphoma. Thanks to Gracell's patented FasTCAR technology, the bioprocessing time for GC007F has been significantly reduced from two weeks to 24 hours with substantially lower cost. The improved CAR-T cell fitness resulted in superior proliferation capabilities, potency, and extensive bone marrow migration making GC007F a potential best-in-class therapy for refractory or relapsed B-ALL.

About Dual CAR-19-22

Dual CAR-19-22, or GC022, is an investigational CAR-T cell therapy redirected to target CD19 and CD22, in treating patients with CD19+, or/and CD22+ relapsed/refractory B-ALL. A low toxicity with dose-dependent high CR rate including patients who previously treated with CD19 CAR-T cells were observed.

About Dual CAR-BCMA-19

Dual CAR-BCMA-19, or GC012, is an investigational CAR-T cell therapy redirected to target BCMA and CD19, in treating patients with BCMA+, or/and CD19+ relapsed/refractory multiple myeloma. Previous research shows CD19 could express on the myeloma progenitor cells, while BCMA is a well validated target for MM.

About Donor CAR-19

Donor CAR-19, or GC007G, is an investigational CD19 targeted CAR-T cell therapy manufactured in use of donor's lymphocytes. The objective of this study is to further investigate and better understand the safety and efficacy of donor derived CAR-T cells in treatment of relapsed and refractory B-ALL patients.

About B-ALL

B-ALL is a sub-type of acute lymphoblastic leukemia, although rare, is one of the most common forms of cancer in children between the ages of two and five and adults over the age of 50[1]. In 2015, ALL affected around 876,000 people globally and resulted in 110,000 deaths worldwide[2]. It is also the most common cause of cancer and death from cancer among children. ALL is typically treated initially with chemotherapy aimed at bringing about remission. This is then followed by further chemotherapy carried out over several years.

About MM

Myeloma begins when a plasma cell becomes abnormal. The abnormal cell divides to make copies of itself. These abnormal plasma cells are called myeloma cells. In time, myeloma cells collect in the bone marrow. They may damage the solid part of the bone. When myeloma cells collect in several of your bones, the disease is called "multiple myeloma." This disease may also harm other tissues and organs, such as the kidneys. Myeloma cells make antibodies called M proteins and other proteins. These proteins can collect in the blood, urine, and organs[3].

About Gracell

Gracell Biotechnologies Co., Ltd. ("Gracell") is a clinical-stage biopharma company, committed to developing highly reliable and affordable cell gene therapies for cancer. Gracell is dedicated to resolving the remaining challenges in CAR-T, such as high production costs, lengthy manufacturing process, lack of off-the-shelf products, and inefficacy against solid tumors. Led by a group of world-class scientists, Gracell is advancing FasTCAR, TruUCAR (off-the-shelf CAR), Dual CAR and Enhanced CAR-T cell therapies for leukemia, lymphoma, myeloma, and solid tumors.

CONTACT:

Linc HE Associate Director of Business Developmentsunwei.he@gracellbio.com

Dr. William Cao Founder, Chairman and CEOwilliam.cao@gracellbio.com

View original content to download multimedia:http://www.prnewswire.com/news-releases/gracell-announces-five-presentations-at-the-annual-meeting-of-american-society-of-hematology-ash-300958982.html

SOURCE Gracell

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Gracell Announces Five Presentations at the Annual Meeting of American Society of Hematology (ASH) - BioSpace

Bone Marrow Stem Cells Comments Off on Gracell Announces Five Presentations at the Annual Meeting of American Society of Hematology (ASH) – BioSpace | November 15th, 2019

Maxim Group analyst Jason McCarthy maintained a Buy rating on Brainstorm Cell Therapeutics (BCLI) yesterday and set a price target of $9.00. The companys shares closed last Monday at $3.70.

According to TipRanks.com, McCarthy has 0 stars on 0-5 star ranking scale with an average return of -22.0% and a 25.3% success rate. McCarthy covers the Healthcare sector, focusing on stocks such as SELLAS Life Sciences Group, Hancock Jaffe Laboratories, and Lineage Cell Therapeutics.

The word on The Street in general, suggests a Moderate Buy analyst consensus rating for Brainstorm Cell Therapeutics with a $9.00 average price target.

See todays analyst top recommended stocks >>

The company has a one-year high of $4.50 and a one-year low of $2.92. Currently, Brainstorm Cell Therapeutics has an average volume of 52.25K.

Based on the recent corporate insider activity of 12 insiders, corporate insider sentiment is negative on the stock. This means that over the past quarter there has been an increase of insiders selling their shares of BCLI in relation to earlier this year. Most recently, in August 2019, Irit Arbel, a Director at BCLI sold 13,332 shares for a total of $48,795.

TipRanks has tracked 36,000 company insiders and found that a few of them are better than others when it comes to timing their transactions. See which 3 stocks are most likely to make moves following their insider activities.

Brainstorm Cell Therapeutics, Inc. operates as a biotechnology company, which develops and commercializes adult stem cell therapeutic products. It focuses on utilizing the patients own bone marrow stem cells to generate neuron-like cells that may provide an effective treatment initially for amyotrophic lateral sclerosis, Parkinsons disease, multiple sclerosis and spinal cord injury. The company was founded on September 22, 2000 and is headquartered in New York, NJ.

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Maxim Group Maintains Their Buy Rating on Brainstorm Cell Therapeutics (BCLI) - Smarter Analyst

Spinal Cord Stem Cells Comments Off on Maxim Group Maintains Their Buy Rating on Brainstorm Cell Therapeutics (BCLI) – Smarter Analyst | November 15th, 2019

SUMMIT, N.J.--(BUSINESS WIRE)--Celgene Corporation (NASDAQ:CELG) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the approval of REVLIMID (lenalidomide) in combination with rituximab (anti-CD20 antibody) (R) for the treatment of adult patients with previously treated follicular lymphoma (FL) (Grade 1-3a). If approved by the European Commission (EC), R2 will be the first combination treatment regimen for patients with FL that does not include chemotherapy.

Since its initial approval in 2007, REVLIMID has continued to demonstrate its benefits across a range of serious blood disorders in Europe and a CHMP positive opinion for this combination with rituximab is very good news for patients with follicular lymphoma. We look forward to the European Commission decision, said Tuomo Ptsi, President of Hematology/Oncology for Celgene Worldwide Markets.

In FL, a subtype of indolent NHL, the immune system is not functioning optimally.1,2 When this dysfunction occurs, the immune system either fails to detect or attack cancerous cells.1,2 Rituximab is a monoclonal antibody that targets the CD 20 antigen on the surface of pre-B and mature B-lymphocytes. Upon binding to CD20, rituximab causes B-cell lysis. Lenalidomide is an immunomodulator that increases the number and activation of T and natural killer (NK) cells, resulting in the lysis of tumor cells. The R2 combination regimen acts by complementary mechanisms to help the patients immune system to find and destroy the cancer cells.3

Given the incurable nature of FL2, a high unmet medical need exists for the development of novel treatment options with new mechanisms of action and a tolerable safety profile to help improve progression-free survival (PFS) especially in the setting of previously treated FL.

The estimated incidence of NHL in Europe was 100,055 cases in 2018; FL accounts for approximately 25% of all NHL cases and is the most common form of indolent NHL.3,4,5

Chemotherapy is a standard of care for indolent forms of NHL, but most patients will relapse or become refractory to their current treatment, said Prof. John Gribben, President of EHA and Centre for Haemato-Oncology, Barts Cancer Institute, in England The combination of REVLIMID and rituximab could represent a new, chemotherapy-free treatment option for patients with previously treated follicular lymphoma.

The CHMP positive opinion is based primarily on results from the randomized, multi-center, double-blind, Phase 3 AUGMENT study, which evaluated the efficacy and safety of the R combination versus rituximab plus placebo in patients with previously treated FL (n=295).6,7 Additionally, findings from the MAGNIFY study were included as support for the safety and the efficacy of lenalidomide plus rituximab in patients with relapsed or refractory FL, including rituximab refractory FL patients.8

The CHMP reviews applications for all member states of the European Union (EU), as well as Norway, Liechtenstein, and Iceland. The European Commission, which generally follows the recommendation of the CHMP, is expected to make its final decision in approximately two months. If approval is granted, detailed conditions for the use of this product will be described in the REVLIMID Summary of Product Characteristics (SmPC), which will be published in the revised European Public Assessment Report (EPAR).

About Follicular Lymphoma

Lymphoma is a blood cancer that develops in lymphocytes, a type of white blood cell in the immune system that helps protect the body from infection.9 There are two classes of lymphoma Hodgkins lymphoma and non-Hodgkins lymphoma (NHL) each with specific subtypes that determine how the cancer behaves, spreads and should be treated.3,10,11 Other differentiating factors of lymphomas are what type of lymphocyte is affected (T cell or B cell) and how mature the cells are when they become cancerous.11

Follicular lymphoma is the most common indolent (slow-growing) form of NHL, accounting for approximately 25% of all Non-Hodgkin lymphoma (NHL) patients.5,12 Most patients present with advanced disease usually when lymphoma-related symptoms appear (e.g., nodal disease, B symptoms, cytopenia) and receive systemic chemoimmunotherapy.5 While follicular lymphoma patients are generally responsive to initial treatment, the disease course is characterized by recurrent relapses over time with shorter remission periods.13

About AUGMENT

AUGMENT is a Phase 3, randomized, double-blind clinical trial evaluating the efficacy and safety of REVLIMID (lenalidomide) in combination with rituximab (R) versus rituximab plus placebo in patients with previously treated follicular lymphoma (FL). AUGMENT included patients diagnosed with Grade 1, 2 or 3a FL, who were previously treated with at least 1 prior systemic therapy and two previous doses of rituximab. Patients were documented relapsed, refractory or progressive disease following systemic therapy, but were not rituximab-refractory.6,7

The primary endpoint was progression-free survival, defined as the time from date of randomization to the first observation of disease progression or death due to any cause. Secondary and exploratory endpoints included overall response rate, durable complete response rate, complete response rate, duration of response, duration of complete response, overall survival, event-free survival and time to next anti-lymphoma therapy.6,7

About REVLIMID

REVLIMID is approved in Europe and the United States as monotherapy, indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma (MM) who have undergone autologous stem cell transplantation. REVLIMID as combination therapy is approved in Europe, in the United States, in Japan and in around 25 other countries for the treatment of adult patients with previously untreated MM who are not eligible for transplant. REVLIMID is also approved in combination with dexamethasone for the treatment of patients with MM who have received at least one prior therapy in nearly 70 countries, encompassing Europe, the Americas, the Middle-East and Asia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy in Australia and New Zealand.

REVLIMID is also approved in the United States, Canada, Switzerland, Australia, New Zealand and several Latin American countries, as well as Malaysia and Israel, for transfusion-dependent anaemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities and in Europe for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk MDS associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

In addition, REVLIMID is approved in Europe for the treatment of patients with mantle cell lymphoma (MCL) and in the United States for the treatment of patients with MCL whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. In Switzerland, REVLIMID is indicated for the treatment of patients with relapsed or refractory MCL after prior therapy that included bortezomib and chemotherapy/rituximab.

REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.

Important Safety Information

WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and VENOUS and ARTERIAL THROMBOEMBOLISM

Embryo-Fetal Toxicity

Do not use REVLIMID during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting REVLIMID treatment. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after REVLIMID treatment. To avoid embryo-fetal exposure to lenalidomide, REVLIMID is only available through a restricted distribution program, the REVLIMID REMS program.

Information about the REVLIMID REMS program is available at http://www.celgeneriskmanagement.com or by calling the manufacturers toll-free number 1-888-423-5436.

Hematologic Toxicity (Neutropenia and Thrombocytopenia)

REVLIMID can cause significant neutropenia and thrombocytopenia. Eighty percent of patients with del 5q MDS had to have a dose delay/reduction during the major study. Thirty-four percent of patients had to have a second dose delay/reduction. Grade 3 or 4 hematologic toxicity was seen in 80% of patients enrolled in the study. Patients on therapy for del 5q MDS should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or reduction. Patients may require use of blood product support and/or growth factors.

Venous and Arterial Thromboembolism

REVLIMID has demonstrated a significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as risk of myocardial infarction and stroke in patients with MM who were treated with REVLIMID and dexamethasone therapy. Monitor for and advise patients about signs and symptoms of thromboembolism. Advise patients to seek immediate medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. Thromboprophylaxis is recommended and the choice of regimen should be based on an assessment of the patients underlying risks.

CONTRAINDICATIONS

Pregnancy: REVLIMID can cause fetal harm when administered to a pregnant female and is contraindicated in females who are pregnant. If this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risk to the fetus

Severe Hypersensitivity Reactions: REVLIMID is contraindicated in patients who have demonstrated severe hypersensitivity (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis) to lenalidomide

WARNINGS AND PRECAUTIONS

Embryo-Fetal Toxicity: See Boxed WARNINGS

REVLIMID REMS Program: See Boxed WARNINGS: Prescribers and pharmacies must be certified with the REVLIMID REMS program by enrolling and complying with the REMS requirements; pharmacies must only dispense to patients who are authorized to receive REVLIMID. Patients must sign a Patient-Physician Agreement Form and comply with REMS requirements; female patients of reproductive potential who are not pregnant must comply with the pregnancy testing and contraception requirements and males must comply with contraception requirements

Hematologic Toxicity: REVLIMID can cause significant neutropenia and thrombocytopenia. Monitor patients with neutropenia for signs of infection. Advise patients to observe for bleeding or bruising, especially with use of concomitant medications that may increase risk of bleeding. MM: Patients taking REVLIMID/dex or REVLIMID as maintenance therapy should have their complete blood counts (CBC) assessed every 7 days for the first 2 cycles, on days 1 and 15 of cycle 3, and every 28 days thereafter. MDS: Patients on therapy for del 5q MDS should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or dose reduction. Please see the Black Box WARNINGS for further information. MCL: Patients taking REVLIMID for MCL should have their CBCs monitored weekly for the first cycle (28 days), every 2 weeks during cycles 2-4, and then monthly thereafter. Patients may require dose interruption and/or dose reduction

Venous and Arterial Thromboembolism: See Boxed WARNINGS: Venous thromboembolic events (DVT and PE) and arterial thromboses (MI and CVA) are increased in patients treated with REVLIMID. Patients with known risk factors, including prior thrombosis, may be at greater risk and actions should be taken to try to minimize all modifiable factors (e.g., hyperlipidemia, hypertension, smoking). Thromboprophylaxis is recommended and the regimen should be based on patients underlying risks. ESAs and estrogens may further increase the risk of thrombosis and their use should be based on a benefit-risk decision

Increased Mortality in Patients with CLL: In a clinical trial in the first-line treatment of patients with CLL, single agent REVLIMID therapy increased the risk of death as compared to single agent chlorambucil. Serious adverse cardiovascular reactions, including atrial fibrillation, myocardial infarction, and cardiac failure, occurred more frequently in the REVLIMID arm. REVLIMID is not indicated and not recommended for use in CLL outside of controlled clinical trials

Second Primary Malignancies (SPM): In clinical trials in patients with MM receiving REVLIMID, an increase of hematologic plus solid tumor SPM, notably AML and MDS, have been observed. Monitor patients for the development of SPM. Take into account both the potential benefit of REVLIMID and risk of SPM when considering treatment

Increased Mortality with Pembrolizumab: In clinical trials in patients with multiple myeloma, the addition of pembrolizumab to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials

Hepatotoxicity: Hepatic failure, including fatal cases, has occurred in patients treated with REVLIMID/dex. Pre-existing viral liver disease, elevated baseline liver enzymes, and concomitant medications may be risk factors. Monitor liver enzymes periodically. Stop REVLIMID upon elevation of liver enzymes. After return to baseline values, treatment at a lower dose may be considered

Severe Cutaneous Reactions: Severe cutaneous reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported. These events can be fatal. Patients with a prior history of Grade 4 rash associated with thalidomide treatment should not receive REVLIMID. Consider REVLIMID interruption or discontinuation for Grade 2-3 skin rash. Permanently discontinue REVLIMID for Grade 4 rash, exfoliative or bullous rash, or for other severe cutaneous reactions such as SJS, TEN, or DRESS.

Tumor Lysis Syndrome (TLS): Fatal instances of TLS have been reported during treatment with lenalidomide. The patients at risk of TLS are those with high tumor burden prior to treatment. These patients should be monitored closely and appropriate precautions taken

Tumor Flare Reaction (TFR): TFR has occurred during investigational use of lenalidomide for CLL and lymphoma. Monitoring and evaluation for TFR is recommended in patients with MCL. Tumor flare may mimic the progression of disease (PD). In patients with Grade 3 or 4 TFR, it is recommended to withhold treatment with REVLIMID until TFR resolves to Grade 1. REVLIMID may be continued in patients with Grade 1 and 2 TFR without interruption or modification, at the physicians discretion

Impaired Stem Cell Mobilization: A decrease in the number of CD34+ cells collected after treatment (>4 cycles) with REVLIMID has been reported. Consider early referral to transplant center to optimize timing of the stem cell collection

Thyroid Disorders: Both hypothyroidism and hyperthyroidism have been reported. Measure thyroid function before start of REVLIMID treatment and during therapy

Early Mortality in Patients with MCL: In another MCL study, there was an increase in early deaths (within 20 weeks), 12.9% in the REVLIMID arm versus 7.1% in the control arm. Risk factors for early deaths include high tumor burden, MIPI score at diagnosis, and high WBC at baseline (10 x 109/L)

Hypersensitivity: Hypersensitivity, including angioedema, anaphylaxis, and anaphylactic reactions to REVLIMID has been reported. Permanently discontinue REVLIMID for angioedema and anaphylaxis.

ADVERSE REACTIONS

Multiple Myeloma

Myelodysplastic Syndromes

Mantle Cell Lymphoma

DRUG INTERACTIONS

Periodic monitoring of digoxin plasma levels is recommended due to increased Cmax and AUC with concomitant REVLIMID therapy. Patients taking concomitant therapies such as erythropoietin stimulating agents or estrogen containing therapies may have an increased risk of thrombosis. It is not known whether there is an interaction between dex and warfarin. Close monitoring of PT and INR is recommended in patients with MM taking concomitant warfarin

USE IN SPECIFIC POPULATIONS

Please see full Prescribing Information, including Boxed WARNINGS.

Please see full SmPC for further information.

About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. For more information, please visit http://www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," "outlook" and similar expressions. Forward-looking statements are based on management's current plans, estimates, assumptions and projections, and speak only as of the date they are made. Celgene undertakes no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond each company's control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in the Annual Report on Form 10-K and other reports of each company filed with the Securities and Exchange Commission, including factors related to the proposed transaction between Bristol-Myers Squibb and Celgene, such as, but not limited to, the risks that: managements time and attention is diverted on transaction related issues; disruption from the transaction make it more difficult to maintain business, contractual and operational relationships; legal proceedings are instituted against Bristol-Myers Squibb, Celgene or the combined company could delay or prevent the proposed transaction; and Bristol-Myers Squibb, Celgene or the combined company is unable to retain key personnel.

1 Scott DW, Gascoyne RD. The tumour microenvironment in B cell lymphomas. Nat Rev Cancer. 2014;14(8):517-534.2 Kridel R, Sehn LH, Gascoyne RD. Pathogenesis of follicular lymphoma. J Clin Invest. 2012;122(10):3424-3431.3 Chiu H, Trisal P, Bjorklund C, et al. Combination lenalidomide-rituximab immunotherapy activates anti-tumour immunity and induces tumour cell death by complementary mechanisms of action in follicular lymphoma. Br J Haematol. 2019;185(2):240-253.4 European Cancer Information System. Estimates of cancer incidence and mortality in 2018, for all countries. Available at: https://ecis.jrc.ec.europa.eu/explorer.php. Accessed August 2019.5 European Society for Medical Oncology. Follicular Lymphoma: A Guide for Patients. 2014. Available at: https://www.esmo.org/content/download/52236/963497/file/EN-Follicular-Lymphoma-Guide-for-Patients.pdf . Accessed September 2019.6 Leonard JP, Trneny M, Izutsu K, et al. AUGMENT: A Phase III Study of Lenalidomide Plus Rituximab Versus Placebo Plus Rituximab in Relapsed or Refractory Indolent Lymphoma. J Clin Oncol. 2019;10;37(14):1188-1199.7 ClinicalTrials.gov Rituximab Plus Lenalidomide for Patients With Relapsed / Refractory Indolent Non-Hodgkin's Lymphoma (Follicular Lymphoma and Marginal Zone Lymphoma) (AUGMENT). Available at: https://clinicaltrials.gov/ct2/show/NCT01938001 Accessed September 2019.8 ClinicalTrials.gov Lenalidomide Plus Rituximab Followed by Lenalidomide Versus Rituximab Maintenance for Relapsed/Refractory Follicular, Marginal Zone or Mantle Cell Lymphoma (MAGNIFY). Available at: https://clinicaltrials.gov/ct2/show/NCT01996865 Accessed August 2019.9 American Cancer Society. Lymphoma. Available at: https://www.cancer.org/cancer/lymphoma.html. Accessed August 2019.10 American Cancer Society. What is Hodgkin Lymphoma? Available at: https://www.cancer.org/cancer/hodgkin-lymphoma/about/what-is-hodgkin-disease.html. Accessed August 2019.11 American Cancer Society. What is Non-Hodgkin Lymphoma? Available at: https://www.cancer.org/cancer/non-hodgkin-lymphoma/about/what-is-non-hodgkin-lymphoma.html. Accessed August 2019.12 Lymphoma Action. Follicular lymphoma. Available at: https://lymphoma-action.org.uk/types-lymphoma-non-hodgkin-lymphoma/follicular-lymphoma. Accessed November 2019.13 Montoto S, Lopez-Guillermo A, Ferrer A, et al. Survival after progression in patients with follicular lymphoma: analysis of prognostic factors. Ann Oncol. 2002;13(4):523-30.

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Celgene Receives CHMP Positive Opinion for REVLIMID (lenalidomide) in Combination With Rituximab for the Treatment of Adult Patients With Previously...

Cardiac Stem Cells Comments Off on Celgene Receives CHMP Positive Opinion for REVLIMID (lenalidomide) in Combination With Rituximab for the Treatment of Adult Patients With Previously… | November 15th, 2019

Bone marrow is soft, spongy tissue within some bones, including those in the hips and thighs. People with certain blood-related conditions benefit from a transplant that replaces damaged cells with healthy cells, possibly from a donor.

Bone marrow transplants can be lifesaving for people with conditions such as lymphoma or leukemia, or when intensive cancer treatment has damaged blood cells.

This type of transplant can be an intensive procedure, and recovery can take a long time.

Here, we provide an overview of bone marrow transplants, including their uses, risks, and recovery.

Bone marrow contains stem cells. In healthy people, stem cells in bone marrow help create:

If a medical condition such as one that damages the blood or immune system prevents the body from creating healthy blood cells, a person may need a bone marrow transplant.

A person with any of the following conditions may be a candidate for a bone marrow transplant:

There are three types of bone marrow transplant, based on where the healthy bone marrow cells come from.

In many cases, the donor is a close family member, such as a sibling or parent. The medical name for this is an allogenic transplant.

Transplants are more likely to be effective if the donated stem cells have a similar genetic makeup to the person's own stem cells.

If a close family member is not available, the doctor will search a registry of donors to find the closest match. While an exact match is best, advances in transplant procedures are making it possible to use donors who are not an exact match.

In a procedure called an autologous transplant, the doctor will take healthy blood stem cells from the person being treated and replace these cells later, after removing any damaged cells in the sample.

In an umbilical cord transplant, also called a cord transplant, doctors use immature stem cells from the umbilical cord following a baby's birth. Unlike cells from an adult donor, the cells from an umbilical cord do not need to be as close a genetic match.

Before a bone marrow transplant, the doctor will run tests to determine the best type of procedure. They will then locate an appropriate donor, if necessary.

If they can use the person's own cells, they will collect the cells in advance and store them safely in a freezer until the transplant.

The person will then undergo other treatment, which may involve chemotherapy, radiation, or a combination of the two.

These procedures typically destroy bone marrow cells as well as cancer cells. Chemotherapy and radiation also suppress the immune system, helping to prevent it from rejecting a bone marrow transplant.

While preparing for the transplant, the person may need to stay in the hospital for 12 weeks. During this time, a healthcare professional will insert a small tube into one of the person's larger veins.

Through the tube, the person will receive medication that destroys any abnormal stem cells and weakens the immune system to prevent it from rejecting the healthy transplanted cells.

Before entering the hospital, it is a good idea to arrange:

A bone marrow transplant is not surgery. It is similar to a blood transfusion.

If a donor is involved, they will provide the stem cells well in advance of the procedure. If the transplant involves the person's own cells, the healthcare facility will keep the cells in storage.

The transplant typically takes place in several sessions over several days. Staggering the introduction of cells in this way gives them the best chance of integrating with the body.

The healthcare team may also use the tube to introduce liquids such as blood, nutrients, and medications to help fight infection or encourage the growth of bone marrow. The combination depends on the body's response to treatment.

The procedure will temporarily compromise the person's immune system, making them very susceptible to infection. Most hospitals have a dedicated, isolated space for people undergoing bone marrow transplants to help reduce their risk of infection.

After the last session, the doctor will continue to check the blood each day to determine how well the transplant has worked. They will test whether new cells are beginning to grow in bone marrow.

If a person's white blood cell count starts to rise, it indicates that the body is starting to create its own blood, indicating that the transplant has been successful.

The amount of time that it takes for the body to recover depends on:

Many other factors can affect recovery, including:

Some people are able to leave the hospital soon after the transplant, while others need to stay for several weeks or months.

The medical team will continue to monitor the person's recovery for up to 1 year. Some people find that effects of the transplant remain for life.

A bone marrow transplant is a major medical procedure. There is a high risk of complications during and after it.

The likelihood of developing complications depends on various factors, including:

Below are some of the more common complications that people who receive bone marrow transplants experience:

Some people die as a result of complications from bone marrow transplants.

A person who receives a bone marrow transplant may also experience reactions that can follow any medical procedure, including:

The body's response to a bone marrow transplant varies greatly from person to person. Factors such as age, overall health, and the reason for the transplant can all affect a person's long term outlook.

If a person receives a bone marrow transplant to treat cancer, their outlook depends, in part, on how far the cancer has spread. Cancer that has spread far from its origin, for example, responds less well to treatment.

According to the National Marrow Donor Program, the 1-year survival rate among people who have received transplants from unrelated donors increased from 42% to 60% over about the past 5 years.

A bone marrow transplant is a major medical procedure that requires preparation. This involves determining the best type of transplant, finding a donor, if necessary, and preparing for a lengthy hospital stay.

The time that it takes for the body to recover from a transplant varies, depending on factors such as a person's age and overall health and the reason for the transplant.

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Bone marrow transplant: What it is, uses, risks, and recovery - Medical News Today

Bone Marrow Stem Cells Comments Off on Bone marrow transplant: What it is, uses, risks, and recovery – Medical News Today | November 14th, 2019

A 6-year-old cocker spaniel in California that was recently diagnosed with cancer is slated to receive stem cells from her mother living 4,000 miles away in the United Kingdom.

Coco the cocker spaniel gave birth to a litter of puppies six years ago. One of those puppies, Millie, was adopted by Serena and Andrew Lodge, who now live in San Francisco. They may live across the world from each other, but the mother and daughter will soon be reunited for the rare treatment, reported South West News Service, or SWNS, a British news agency.

CHEAPER MEDICATION FOR DOGS WITH SEPARATION ANXIETY NOW APPROVED, FDA SAYS

Coco, left, and daughter, Millie. (SWNS)

The transplant will occur at the North Carolina State Veterinary Hospital in Raleigh. The facility isreportedly one of only a few animal hospitals in the world to offer the treatment, which involves taking healthy stem cells from Cocos bone marrow and injecting them intoMillies.

"Serena and Andrew started chemo on Millie three months ago but they've been told the only chance they'll have of curing her is if they find a positive donor so she can have a transplant, said Cocos owner, Robert Alcock, 52. He arrived with Coco in North Carolina on Wednesday.

Millie while in an animal hospital. (SWNS)

"They contacted us, and we sent some blood samples for testing, along with samples from one of Coco's other pups, he added. They both came back positive but because Coco is Millie's mother the vet said she would be a better match."

"Coco will go into hospital on Sunday for the procedure and then the cells will be donated on Monday, he continued, noting the Lodges have paid for everything.

Robert Alcock and his cocker spaniel, Coco. (SWNS)

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Coco is expected to make a full recovery following the procedure. However, there is only a 50 percent chance Millie will be cured even if the treatment is successful, according to SWNS.

Stem cell therapy for pets is costly, typically setting an owner back between $2,000 and $3,000, according to Pet WebMD.

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Cocker spaniel with cancer to receive stem cells from mother living 4,000 miles away - Fox News

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