SAN CARLOS, Calif., Nov. 10, 2020 (GLOBE NEWSWIRE) -- BioCardia, Inc.[NASDAQ: BCDA], a leader in the development of autologous and allogenic cell therapies, today reported financial results and business highlights for the third quarter of 2020 and filed its quarterly report on Form 10-Q for the three and nine months ended September 30, 2020 with the Securities and Exchange Commission on November 10, 2020.

The Company is advancing its autologous and allogenic bone marrow-derived cell therapies for three cardiovascular indications and one respiratory indication.

Third Quarter 2020 Business Highlights:

Autologous Cell Therapies

Allogenic Cell Therapies

Corporate Developments

We are reaching critical milestones in our cardiovascular and respiratory cell therapy development programs at a time when patients are increasingly presenting with heart damage due to COVID-19, said BioCardia CEO Peter Altman, PhD. We believe that the clinical data supports patient benefit through paracrine mechanisms, which differs from those attempting to transform cells into new heart cells, and believe that the approach has tremendous promise to help patients suffering from severe heart and respiratory diseases.

Third Quarter 2020 Financial Results:

Anticipated Upcoming Milestones in Q4 2020:

About BioCardiaBioCardia, Inc., headquartered in San Carlos, California, is developing regenerative biologic therapies to treat cardiovascular and respiratory disease. CardiAMP autologous and Neurokinin-1 Receptor Positive allogenic cell therapies are the Companys biotherapeutic platforms in clinical development. The Company's products include the Helix Biotherapeutic Delivery System and its steerable guide and sheath catheter portfolio. BioCardia also partners with other biotherapeutic companies to provide its Helix system and clinical support for their programs studying therapies for the treatment of heart failure, chronic myocardial ischemia and acute myocardial infarction. For more information, visit http://www.BioCardia.com.

Forward Looking StatementsThis press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to the enrollment of our clinical trials, the availability of data from our clinical trials, filings with the FDA, FDA product clearances, the efficacy and safety of our products and therapies, anticipated milestones, and other statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations. Such risks and uncertainties include, among others, the inherent uncertainties associated with developing new products or technologies, regulatory approvals, unexpected expenditures, the ability to raise the additional funding needed to continue to pursue BioCardias business and product development plans and overall market conditions.We may find it difficult to enroll patients in our clinical trials due to many factors, some of which are outside of our control.Slower than targeted enrollment could delay completion of our clinical trials and delay or prevent development of our therapeutic candidates.These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements.

We may use terms such as believes, estimates, anticipates, expects, plans, intends, may, could, might, will, should, approximately or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate.Additional factors that could materially affect actual results can be found in our documents filed with the SEC, including our recent filings on Form 8-K, Form 10-K and Form 10-Q, particularly any statements under the caption entitled Risk Factors Therein. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.

Media Contact:Michelle McAdam, Chronic Communications, Inc.michelle@chronic-comm.com(310) 902-1274

Investor Contact:David McClung, Chief Financial OfficerInvestors@BioCardia.com(650) 226-0120

BIOCARDIA, INC.Condensed Statements of Operations(Unaudited In thousands, except share and per share amounts)

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BioCardia Reports Third Quarter 2020 Financial Results and Business Highlights - GlobeNewswire

Bone Marrow Stem Cells Comments Off on BioCardia Reports Third Quarter 2020 Financial Results and Business Highlights – GlobeNewswire | November 10th, 2020

A TEENAGE Jehovah's Witness was ordered to undergo a lifesaving blood transfusion after a concerned judge quashed her religious objection.

Doctors received the go-ahead to urgently give the 15-year-old blood when she was just hours from death.

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The teen suffers from sickle cell, an inherited condition that affects red blood cells.

It puts her at greater risk of suffering a debilitating stroke - or dying.

At the High Court on Tuesday, November 10, Sir James Munby said the girl's life was in imminent danger, so he had rushed to make his decision, reports the Daily Mail.

He explained: "The blood transfusion is imperatively needed and within a timescale measured in hours, and not days.

"At one point, her doctor lamented that four hours had gone by because of the judicial proceedings."

Sir James described the patient as "wise beyond her years".

The unnamed teen has recently been baptised as a Jehovah's Witness, and has "profound religious beliefs".

Although Jehovah's Witnesses do not accept blood transfusions or blood products, based on biblical readings, he warned failure to help her presented a "very real risk" of "serious harm to her future health and welfare".

He acknowledged that the girl may end up refusing blood transfusions when older, and has more say on her medical treatment.

3

Sir James suggested that legal precedents dating back three decades needed to be re-examined for cases like this.

These previous decisions state that kids shouldn't have a say in whether or not they accept medical treatment.

In just three years time, when she reaches the age of 18, the girl will be legally able to reject such lifesaving help.

However, Sir James recommended the High Court to look at whether she should have more say on treatments - including blood transfusions - before she turns 18.

A 1970s ruling says Jehovah's Witnesses' beliefs must be given the same respect as those of other religions when it comes to kids' rights to reject treatment.

Appeal Court decisions in the 1990s stress that courts must decide what is in the best interests of under-16s, the Mail writes.

Teens aged 16 and 17 are allowed to have a say in their treatment - but this can be overruled in exceptional cases.

What is Sickle Cell?

Sickle cell disease (SCD) is a serious and lifelong health condition.

Sickle cell disease is the name for a group of inherited health conditions that affect the red blood cells.

The most serious type is called sickle cell anaemia.

People with sickle cell disease produce unusually shaped red blood cells.

These can cause problems because they do not live as long as healthy blood cells and can block blood vessels.

People with SCD start to have signs of the disease during the first year of life, usually around five months of age.

Symptoms and complications of SCD are different for each person and can range from mild to severe.

The only cure for SCD is bone marrow or stem cell transplant.

Sickle cell disease varies between individuals from mild to serious, but most people with it lead happy and normal lives.

But the illness can be serious enough to have a significant effect on a person's life, says the NHS.

It can lead to health problems like strokes, serious infections and lung problems, which can occasionally be fatal.

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Jehovahs Witness, 15, shouldnt be allowed to die says High Court judge after teen refuses lifesaving blood t - The Sun

Bone Marrow Stem Cells Comments Off on Jehovahs Witness, 15, shouldnt be allowed to die says High Court judge after teen refuses lifesaving blood t – The Sun | November 10th, 2020

DetailsCategory: Small MoleculesPublished on Monday, 09 November 2020 08:56Hits: 725

Calquence demonstrated superior progression-free survival and favourable tolerability in both previously untreated and relapsed or refractory patients

LONDON, UK I November 9, 2020 I AstraZenecas Calquence (acalabrutinib), a next-generation selective Brutons tyrosine kinase (BTK) inhibitor, has been approved in the European Union (EU) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL), the most common type of leukaemia in adults.

The approval by the European Commission was based on positive results from two Phase III clinical trials, ELEVATE-TN in patients with previously untreated CLL and ASCEND in patients with relapsed or refractory CLL.1,2 This follows a recommendation for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency in July 2020.

Paolo Ghia, MD, Director, Strategic Research Program on CLL, Universit Vita-Salute San Raffaele in Milan, and investigator of the ASCEND Phase III trial, said: One of our biggest hurdles in treating chronic lymphocytic leukaemia is finding tolerable treatment options that manage the disease long term, which typically impacts older patients with comorbidities. Todays news marks great progress for patients in Europe, as the Phase III clinical trials for Calquence showed a significant improvement in comparison with current standard treatments.

Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: This approval represents a key development for patients in Europe who until now have had limited chemotherapy-free treatment options. As our first European approval in blood cancers, Calquence provides a new tolerable treatment option with uncompromised efficacy and the potential to positively impact the quality of life for thousands of patients living with chronic lymphocytic leukaemia.

In the ELEVATE-TN Phase III trial, Calquence combined with obinutuzumab and as monotherapy reduced the risk of disease progression or death by 90% and 80%, respectively, compared with standard chemo-immunotherapy treatment chlorambucil plus obinutuzumab, in patients with previously untreated CLL.1 In the ASCEND Phase III trial, 88% of patients with relapsed or refractory CLL taking Calquence remained alive and free from disease progression after 12 months compared with 68% of patients on rituximab combined with idelalisib or bendamustine.2 Data from the interim results of the trials were published in The Lancet and Journal of Clinical Oncology, respectively.

Calquence is approved for the treatment of CLL and small lymphocytic lymphoma in the US and is approved for CLL in several other countries worldwide. Calquence is also approved for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy in the US and several other countries. Calquence is not currently approved for the treatment of MCL in Europe.

As part of a broad development programme, Calquence is being assessed in more than 20 AstraZeneca-sponsored clinical trials for the treatment of patients with B-cell malignancies including CLL, MCL, diffuse large B-cell lymphoma (DLBCL), Waldenstrms macroglobulinaemia (WM), follicular lymphoma (FL), and other haematologic malignancies.

Chronic lymphocytic leukaemia

Chronic lymphocytic leukaemia (CLL) is the most common type of leukaemia in adults, with an estimated 105,000 new cases globally in 2016, and the number of people living with CLL is expected to grow with improved treatment as patients live longer with the disease.3,4,5,6 In CLL, too many blood stem cells in the bone marrow become abnormal lymphocytes and these abnormal cells have difficulty fighting infections. As the number of abnormal cells grows there is less room for healthy white blood cells, red blood cells, and platelets. This could result in anaemia, infection, and bleeding.4 B-cell receptor signalling through BTK is one of the essential growth pathways for CLL.

ELEVATE-TN

ELEVATE-TN (ACE-CL-007) was a randomised, multicentre, open-label Phase III trial evaluating the safety and efficacy of Calquence in combination with obinutuzumab, a CD20 monoclonal antibody, or Calquence alone versus chlorambucil, a chemotherapy, in combination with obinutuzumab in previously untreated patients with CLL. Patients 65 years of age or older, or between 18 and 65 years of age with a total Cumulative Illness Rating Scale >6 or creatinine clearance of 30 to 69mL/min, were enrolled. In the trial, 535 patients were randomised (1:1:1) into three arms. Patients in the first arm received chlorambucil in combination with obinutuzumab. Patients in the second arm received Calquence (100mg approximately every 12 hours until disease progression or unacceptable toxicity) in combination with obinutuzumab. Patients in the third arm received Calquence monotherapy (100mg approximately every 12 hours until disease progression or unacceptable toxicity).1

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

ASCEND

ASCEND (ACE-CL-309) was a global, randomised, multicentre, open-label Phase III trial evaluating the efficacy of Calquence in patients with relapsed or refractory CLL. In the trial, 310 patients were randomised (1:1) into two arms. Patients in the first arm received Calquence monotherapy (100mg twice daily until disease progression or unacceptable toxicity). Patients in the second arm received investigators choice of either rituximab, a CD20 monoclonal antibody, in combination with idelalisib, a PI3K inhibitor, or rituximab in combination with bendamustine, a chemotherapy.2

The primary endpoint was PFS assessed by an IRC, and key secondary endpoints included physician-assessed PFS, IRC- and physician-assessed overall response rate and duration of response, as well as OS, patient-reported outcomes and time to next treatment.2

Calquence

Calquence (acalabrutinib) is a next-generation, selective inhibitor of BTK. Calquence binds covalently to BTK, thereby inhibiting its activity.7,8 In B-cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.7

As part of an extensive clinical development programme, AstraZeneca and Acerta Pharma are currently evaluating Calquence in more than 20 company-sponsored clinical trials. Calquence is being developed for the treatment of multiple B-cell blood cancers including CLL, MCL, DLBCL, WM, FL, and other haematologic malignancies.

AstraZeneca in haematology

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

AstraZeneca in oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio ofnew medicines that has the potential to transform patients lives and the Companys future. With seven new medicines launched between 2014 and 2020, and a broad pipelineof small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and haematology.

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

AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. Please visitastrazeneca.comand follow the Company on Twitter@AstraZeneca.

References

1. Sharman JP, et al. ELEVATE TN: Phase 3 Study of Acalabrutinib Combined with Obinutuzumab (O) or Alone Vs O Plus Chlorambucil (Clb) in Patients (Pts) with Treatment-Naive Chronic Lymphocytic Leukemia (CLL). Blood. 2019; 134 (Supplement_1): 31. doi:10.1182/blood-2019-128404.

2. Ghia P, et al. ASCEND: Phase III, Randomized Trial of Acalabrutinib Versus Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in Relapsed or Refractory Chronic Lymphocytic Leukemia [published online ahead of print, 2020 May 27]. J Clin Oncol. 2020; JCO1903355. doi:10.1200/JCO.19.03355.

3. American Cancer Society. What is Chronic Lymphocytic Leukemia? Available at https://www.cancer.org/cancer/chronic-lymphocytic-leukemia/about/what-is-cll.html. Accessed August 2020.

4. National Cancer Institute. Chronic Lymphocytic Leukemia Treatment (PDQ)Patient Version. Available at https://www.cancer.gov/types/leukemia/patient/cll-treatment-pdq. Accessed August 2020.

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

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

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

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

SOURCE: AstraZeneca

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Calquence approved in the EU for the treatment of chronic lymphocytic leukaemia | Small Molecules | News Channels - PipelineReview.com

Bone Marrow Stem Cells Comments Off on Calquence approved in the EU for the treatment of chronic lymphocytic leukaemia | Small Molecules | News Channels – PipelineReview.com | November 10th, 2020

One of the biggest challenges that scientists and healthcare professionals are facing during the COVID-19 pandemic is the high rate of clinical variability. Whilst some patients present as asymptomatic, others are developing more severe symptoms such as pneumonia, and some cases are ultimately proving fatal. Why?The answer remains elusive; however, extensive research is exploring the possible contribution our genetics may be having. Genetic variation differences in the DNA sequences that make up our genome can impact our response to infectious diseases.

GoodCell uniquely measures and monitors inherited and acquired genetic variations in stem cells and other nucleated cells in our blood over time. Technology Networks recently spoke with Dr Salvatore Viscomi, chief medical officer at GoodCell, and attending physical at Baystate Health, to explore factors that might influence COVID-19 risk, and to discuss how the company is working to identify at-risk individuals through genetic variation analysis.

Molly Campbell (MC): For our readers that may be unfamiliar, can you discuss why medicine is moving towards a personalized approach, and why this is important considering genetic variation?Salvatore Viscomi (SV): Healthcare has traditionally taken the approach of one size fits all in defining individual risk for a disease and prescribing therapy for it. Understanding the differences between individuals on a molecular level optimizes assessment of an individuals susceptibility to a certain disease and predicting response to pharmacological therapy. Genomics plays the most important role in the emergence of personalized therapy. Identifying the inherited and acquired genetic variation will direct personalized screening and prevention plans and inform bespoke medical therapies.

MC: We know that there is high clinical variability across COVID-19 patients. How might genetic variation be contributing here, and what published evidence exists to support this?SV: Understanding immune response is critical to identifying individuals at high risk of severe morbidity and mortality. Emerging research suggests that accumulated genetic variation in our blood cells may be associated with a dysfunctional inflammatory response to COVID-19 leading to its pulmonary, cardiac and coagulopathic complications.

In a recent study published by JAMA Cardiology, researchers demonstrated an association between the presence of accumulated genetic change in our blood cells and a pro-inflammatory immune response that resembles the exaggerated cytokine release syndrome (CRS) manifested in COVID-19-positive patients. Direct evidence has emerged more recently; a study published in Cancers examined patients hospitalized with COVID-19 and found a significantly higher prevalence of accumulated genetic variation in all age groups compared to age-matched control groups.

MC: What impact might genetic variation in COVID-19 patients have on efforts to develop therapeutics or preventives, such as vaccines?SV: Identifying highly susceptible individuals through blood testing could have many applications. As an initial wave of vaccines move through Phase III trials and potentially come to market, we would have the data to determine prioritization of vaccinations when one is available. Business and government sectors need insight into risk factors that can inform inoculation strategies for societys most vulnerable, inform decisions around who should and should not be on the front lines, and give people more control when making personal decisions about how to mitigate individual risk. The broader field of genetics offers a window into the potential to correlate inherited and acquired gene mutations with immune response for the betterment of society, providing a more robust and accurate set of risk factors unique to every individual.

Furthermore, in high-risk individuals, targeting inflammation may be a clinical strategy to mitigate its clinical consequencesin COVID-19. For example, we may identify patients who are most responsive to pro-inflammatory inhibitors. Implementing measures intended to reduce subjects exposure to the infection or likelihood of contracting such infection through self-isolation, quarantine or social distancing may be advised.

MC: Can you explain the aims of GoodCell, and what the company does in terms of "banking blood for life"?SV: GoodCells mission is to extend and improve the quality of life through technology powered by our own cells. Blood is the author of our bodies, and can both cure as well as cause disease. Through our proprietary data aggregation and analytics technology platform, which aims to decode our blood cells and harness their insights to advance population and personal health, we empower individuals to identify, track and mitigate health risks. By getting ahead of their health risks, we enable the potential for a better life. In addition, through our personal biobanking service, long-term storage of your healthiest cells provides the opportunity for potential use in future therapeutics if you need them you are your best donor.

MC: Does GoodCell measure other "omics" parameters outside of genomics (DNA measurements and analysis), such as proteomics or metabolomics?SV: GoodCells platform leverages the power of blood to assess risk as such, we of course look at acquired and inherited genetic changes, but there are many more opportunities afforded by blood to understand and assess risk including routine blood chemistry tests, tests for biomarkers of disease, including emerging capabilities in liquid biopsy for earlier detection of solid tumor cancers. Ultimately, we are always looking to incorporate novel health and data insights into our product platform to better inform both an individuals health, as well as population-based health. Transcriptomics, epigenomics and metabolomics are but a few of the opportunities we are evaluating.

MC: What work is GoodCell currently conducting in the COVID-19 space?SV: GoodCell is currently engaged in a research collaboration with the New York Blood Center to evaluate how specific acquired and inherited genetic variation contribute to COVID-19 severity and recovery. We are analyzing genetic variation in asymptomatic/mildly symptomatic patients compared to hospitalized/ICU patients. GoodCell will evaluate the genetic variation in the collected samples using our proprietary assay platform to identify and validate their association with COVID-19 morbidity and mortality.

Salvatore Viscomi was speaking to Molly Campbell, Science Writer, Technology Networks.

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Exploring Genetic Variation and COVID-19 Clinical Variability - Technology Networks

Cardiac Stem Cells Comments Off on Exploring Genetic Variation and COVID-19 Clinical Variability – Technology Networks | November 10th, 2020

KENILWORTH, N.J., & WOODCLIFF LAKE, N.J.--(BUSINESS WIRE)--Nov 10, 2020--

Merck (NYSE: MRK):

KEYTRUDA (pembrolizumab) Plus LENVIMA (lenvatinib) Demonstrated Statistically Significant Improvement inProgression-Free Survival (PFS), Overall Survival (OS) and Objective Response Rate (ORR) Versus Sunitinib as First-Line Treatment for Patients With Advanced Renal Cell Carcinoma

LENVIMA Plus Everolimus Also Showed Statistically Significant Improvement in PFS and ORR Endpoints Versus Sunitinib

Results of Investigational Phase 3 KEYNOTE-581/CLEAR Trial (Study 307) to be Presented at Upcoming Medical Meeting

Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Eisai today announced new investigational data demonstrating positive top-line results from the pivotal Phase 3 KEYNOTE-581/CLEAR trial (Study 307). In the trial, the combinations of KEYTRUDA, Mercks anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, and LENVIMA plus everolimus were evaluated versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC). KEYTRUDA plus LENVIMA met the trials primary endpoint of progression-free survival (PFS) and its key secondary endpoints of overall survival (OS) and objective response rate (ORR), demonstrating a statistically significant and clinically meaningful improvement in PFS, OS and ORR versus sunitinib in the intention-to-treat (ITT) study population. LENVIMA plus everolimus also met the trials primary endpoint of PFS and a key secondary endpoint of ORR, demonstrating a statistically significant and clinically meaningful improvement in PFS and ORR versus sunitinib in the ITT study population. The ITT population included patients across all Memorial Sloan Kettering Cancer Center (MSKCC) risk groups (favorable, intermediate and poor). The safety profiles of both KEYTRUDA plus LENVIMA and LENVIMA plus everolimus were consistent with previously reported studies. Merck and Eisai will discuss these data with regulatory authorities worldwide, with the intent to submit marketing authorization applications based on these results, which will be presented at an upcoming medical meeting.

The results for KEYTRUDA plus LENVIMA versus sunitinib, which showed a statistically significant improvement in progression-free survival, overall survival and objective response rate, build on the growing scientific evidence that supports the investigation of KEYTRUDA-based combinations for the first-line treatment of advanced renal cell carcinoma, said Dr. Gregory Lubiniecki, Associate Vice President, Oncology Clinical Research, Merck Research Laboratories. Merck and Eisai are committed to working together to continue to explore the potential of the KEYTRUDA plus LENVIMA combination, particularly in areas of great unmet need such as renal cell carcinoma.

The results from KEYNOTE-581/CLEAR (Study 307) support the potential use of KEYTRUDA plus LENVIMA for the first-line treatment of advanced RCC. These data also support the potential first-line use of LENVIMA plus everolimus, which is already approved in advanced RCC following prior antiangiogenic therapy, said Dr. Takashi Owa, Vice President, Chief Medicine Creation and Chief Discovery Officer, Oncology Business Group at Eisai. These findings energize our efforts as we continue to advance our understanding and address the unmet needs of patients with difficult-to-treat cancers.

Merck and Eisai are continuing to study the KEYTRUDA plus LENVIMA combination through the LEAP (LEnvatinib And Pembrolizumab) clinical program across 19 trials in 13 different tumor types (endometrial carcinoma, hepatocellular carcinoma, melanoma, non-small cell lung cancer, RCC, squamous cell carcinoma of the head and neck, urothelial cancer, biliary tract cancer, colorectal cancer, gastric cancer, glioblastoma, ovarian cancer and triple-negative breast cancer).

About KEYNOTE-581/CLEAR (Study 307)

KEYNOTE-581/CLEAR (Study 307) is a multi-center, randomized, open-label, Phase 3 trial (ClinicalTrials.gov, NCT02811861 ) evaluating LENVIMA in combination with KEYTRUDA or in combination with everolimus versus sunitinib for the first-line treatment of patients with advanced RCC. The primary endpoint is PFS by independent review per RECIST v1.1 criteria. Key secondary endpoints include OS, ORR and safety. The study enrolled approximately 1,050 patients who were randomized to one of three treatment arms to receive:

About Renal Cell Carcinoma (RCC)

Worldwide, it is estimated there were more than 403,000 new cases of kidney cancer diagnosed and more than 175,000 deaths from the disease in 2018. In the U.S. alone, it is estimated there will be nearly 74,000 new cases of kidney cancer diagnosed and almost 15,000 deaths from the disease in 2020. Renal cell carcinoma is by far the most common type of kidney cancer; about nine out of 10 kidney cancers are RCCs. Renal cell carcinoma is about twice as common in men as in women. Most cases of RCC are discovered incidentally during imaging tests for other abdominal diseases. Approximately 30% of patients with RCC will have metastatic disease at diagnosis, and as many as 40% will develop metastases after primary surgical treatment for localized RCC. Survival is highly dependent on the stage at diagnosis, and with a five-year survival rate of 12% for metastatic disease, the prognosis for these patients is poor.

About KEYTRUDA (pembrolizumab) Injection, 100 mg

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

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications

Melanoma

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

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

Non-Small Cell Lung Cancer

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

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

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

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

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

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

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

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

KEYTRUDA is indicated for the treatment of pediatric patients with refractory cHL, or cHL that has relapsed after 2 or more lines of therapy.

Primary Mediastinal Large B-Cell Lymphoma

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

Urothelial Carcinoma

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

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

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

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

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

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Cancer

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

Esophageal Cancer

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

Cervical Cancer

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

Hepatocellular Carcinoma

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

Merkel Cell Carcinoma

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

Renal Cell Carcinoma

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

Endometrial Carcinoma

KEYTRUDA, in combination with LENVIMA, is indicated for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.

Tumor Mutational Burden-High

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Selected Important Safety Information for KEYTRUDA (pembrolizumab)

Immune-Mediated Pneumonitis

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

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

Immune-Mediated Colitis

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

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

Immune-Mediated Hepatitis

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

Hepatotoxicity in Combination With Axitinib

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

Immune-Mediated Endocrinopathies

KEYTRUDA can cause adrenal insufficiency (primary and secondary), hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Adrenal insufficiency occurred in 0.8% (22/2799) of patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (<0.1%). Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%) receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.

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

Immune-Mediated Nephritis and Renal Dysfunction

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

Immune-Mediated Skin Reactions

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

Other Immune-Mediated Adverse Reactions

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

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

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

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

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

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

Increased Mortality in Patients With Multiple Myeloma

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

Embryofetal Toxicity

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

Adverse Reactions

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

In KEYNOTE-002, KEYTRUDA was permanently discontinued due to adverse reactions in 12% of 357 patients with advanced melanoma; the most common (1%) were general physical health deterioration (1%), asthenia (1%), dyspnea (1%), pneumonitis (1%), and generalized edema (1%). The most common adverse reactions were fatigue (43%), pruritus (28%), rash (24%), constipation (22%), nausea (22%), diarrhea (20%), and decreased appetite (20%).

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

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

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

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KEYTRUDA (pembrolizumab) Plus LENVIMA (lenvatinib) Demonstrated Statistically Significant Improvement in Progression-Free Survival (PFS), Overall...

Cardiac Stem Cells Comments Off on KEYTRUDA (pembrolizumab) Plus LENVIMA (lenvatinib) Demonstrated Statistically Significant Improvement in Progression-Free Survival (PFS), Overall… | November 10th, 2020

The report on the Progenitor Cell Product Market offers elaborated knowledge on the Progenitor Cell Product market. parts like dominating firms, classification, size, business atmosphere, SWOT analysis, and most effectual trends within the business area unit comprised during this analysis study. In this report, the global Progenitor Cell Product market is valued at USD XX million in 2020and is expected to reach USD XX million by the end of 2026, growing at a CAGR of XX% between 2020and 2026. additionally to the current, the report sports charts, numbers, and tables that provide a transparent viewpoint of the Progenitor Cell Product market. The dominant firms NeuroNova AB, StemCells, ReNeuron Limited, Asterias Biotherapeutics, Thermo Fisher Scientific, STEMCELL Technologies, Axol Bio, RD Systems, Lonza, ATCC, Irvine Scientific, CDI area unit to boot mentioned within the report.

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The Global Progenitor Cell Product market report includes a profound outline of the key sectors of the Progenitor Cell Product market. each quickly and slowly growing sectors of the Progenitor Cell Product market are examined via this study. Forecast, share of the market, and size of every s and sub-segment is getable within the study. The key energetic possibilities associated with the foremost quickly growing segments of the market also are a fracturing of this report. what is more, classification supported geographies also because the trends powering the leading regional markets and developing geographies is obtainable during this analysis study. the Global Progenitor Cell Product market report wraps regions that area unit in the main classified into North America, Europe, Asia Pacific, Latin America, and Mideast and Africa.

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There are 15 Chapters to display the Global Progenitor Cell Product market

Chapter 1,Definition, Specifications and Classification of Progenitor Cell Product, Applications of Progenitor Cell Product, Market Segment by Regions;Chapter 2,Manufacturing Cost Structure, Raw Material, and Suppliers, Manufacturing Process, Industry Chain Structure;Chapter 3,Technical Data and Manufacturing Plants Analysis of Progenitor Cell Product, Capacity, and Commercial Production Date, Manufacturing Plants Distribution, R&D Status and Technology Source, Raw Materials Sources Analysis;Chapter 4,Overall Market Analysis, Capacity Analysis (Company Segment), Sales Analysis (Company Segment), Sales Price Analysis (Company Segment);Chapter 5 and 6,Regional Market Analysis that includes the United States, China, Europe, Japan, Korea & Taiwan, Progenitor Cell Product Segment Market Analysis (by Type);Chapter 7 and 8,The Progenitor Cell Product Segment Market Analysis (by Application) Major Manufacturers Analysis of Progenitor Cell Product ;Chapter 9,Market Trend Analysis, Regional Market Trend, Market Trend by Product Type Pancreatic progenitor cells, Cardiac Progenitor Cells, Intermediate progenitor cells, Neural progenitor cellsEndothelial progenitor cellsOthers, Market Trend by Application;Chapter 10,Regional Marketing Type Analysis, International Trade Type Analysis, Supply Chain Analysis;Chapter 11,The Consumers Analysis of Global Progenitor Cell Product ;Chapter 12,Progenitor Cell Product Research Findings and Conclusion, Appendix, methodology and data source;Chapter 13, 14, and 15,Progenitor Cell Product sales channel, distributors, traders, dealers, Research Findings and Conclusion, appendix, and data source.

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Global Progenitor Cell Product Professional Survey 2020 by Manufacturers, Regions, Types and Applications, Forecast to 2026 - Zenit News

Cardiac Stem Cells Comments Off on Global Progenitor Cell Product Professional Survey 2020 by Manufacturers, Regions, Types and Applications, Forecast to 2026 – Zenit News | November 10th, 2020

Pune, Maharashtra,India, November 9 2020 (Wiredrelease) Origius Systems Private Limited :The increasing occurrence of chronic ailments and obesity all over the world is driving the global biopreservation market growth. The North America region is expected to lead the market growth in the projected period.

A latest report by Research Dive on the global biopreservation market reveals that the market is projected to hit $13,576.3 million by 2027, rising at a CAGR of 13.8% from 2020 to 2027. The report states the current outlook and future growth of the market. The research report is a perfect source of guidance for companies and individuals interested in investing in the market.

The report covers the following aspects:

A brief introduction of the market with its definition, advantages, and application areas. Inclusive insights on the market situation, dynamics, statistics, growth rate, revenues, market shares, and future predictions. Major market segments, drivers, limitations, and investment suitability. Current scenario of the global and regional market from the perspective of companies, countries, and end industries. Insights on foremost market players, current market trends & developments, SWOT Analysis, Porter Five Analysis, and winning business strategies.

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Factors Impacting the Market Growth:

According to the report, growing occurrence of chronic ailments like diabetes, cardiac, degenerative conditions affecting the joints, nerves, bones, and others as well as obesity all over the world are thrusting the demand for biopreservation techniques, which is fueling the growth of the market. Additionally, the increasing investments in R&D and development of advanced biopreservation products is expected to unlock rewarding opportunities for the market growth. However, greater costs involved in biopreservation processes, reliability concerns, and invention of low-priced processes are likely to detain the biopreservation market growth.

Segment Analysis:

The report segments the biopreservation market into type, biospecimen, application, end use, and region.

Based on biospecimen, the report divides the market into: Stem Cells Human Tissue Organs

Among these, the human tissue segment is expected to witness highest growth in the biopreservation market all through the projected period; mainly due to rising cases of chronic ailments, degenerative disorders, and obesity.

Based on application, the report classifies the market into: Therapeutic Research Clinical Trials

Among these, the therapeutic segment is projected to show noteworthy growth during the forecast period. This is mainly owing to the developments in treatment techniques, personalized drugs, regenerative drugs, increasing trend for cord blood banking, and increasing occurrence of chronic ailments worldwide.

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Regional Analysis:

The report states the scenario of the global biopreservation market across several regions including: Europe LAMEA North America Asia Pacific

Among these, the North America region is projected to grab the highest market share of the biopreservation market in the forecast period. This is attributed to the growing awareness about personalized drugs, rising R&D in regenerative medicines, increasing prevalence of obesity, and chronic ailments.

Market Players and Business Strategies:

The report cites some of the leading players in the global biopreservation market which includes: Avantor, Inc. Bio-Techne Exact Sciences Corporation Merck KGaA ThermoGenesis Corp. BioLifeSolutions Inc. BioCision Chart Industries Thermo Fisher Scientific Inc. Worthington Industries, Inc.

The report highlights some of the wining business strategies of the players such as mergers and acquisitions, ground-breaking advances, geographical expansions, new product inventions, and many more.Quick Download Top Companies Development Strategies Summary Report

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Advancement: Know the Rapid Growth Factors of Biopreservation Market| Stay Up-To-Date With Emerging - PharmiWeb.com

Cardiac Stem Cells Comments Off on Advancement: Know the Rapid Growth Factors of Biopreservation Market| Stay Up-To-Date With Emerging – PharmiWeb.com | November 10th, 2020

Global Mesenchymal Stem Cells market report 2020 offers extremely oblique professional analysis and forecast from 2020 to 2026. The report also consists of market shares, size, profit revenue, and the Mesenchymal Stem Cells markets economic process. It also covers the strategic identification of major players within the market and analyzing their core competencies and methodology. The Mesenchymal Stem Cells market report analyzes information collected and integrated through recent analysis techniques and from trustful sources across varied industries.

A thorough evaluation of the restrains encompassed in the Mesenchymal Stem Cells report reveals the difference to drivers and contributes room for strategic planning. Features that overshadow the Mesenchymal Stem Cells market development are essential. They can be understood to devise different bends for getting hold of the profitable prospects present in the ever-growing market. Additionally, perceptions by market expert opinions have been taken to understand the Mesenchymal Stem Cells market better.

[Due to the pandemic, we have included a special section on the Impact of COVID 19 on the market which would mention How the Covid-19 is Affecting the Global Mesenchymal Stem Cells Market]

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Top Key Players of Mesenchymal Stem Cells Market:

(Celprogen Inc., Axol Bioscience Ltd., Stemedica Cell Technologies Inc., Cell Applications Inc., Stem cell technologies Inc., Cytori Therapeutics Inc., Cyagen Biosciences Inc., BrainStorm Cell Therapeutics.)

On the basis of Types, the Mesenchymal Stem Cells market:

Bone Marrow Umbilical Cord Blood Peripheral Blood Lung Tissue Synovial Tissues Amniotic Fluids Adipose Tissues

On the basis of Applications, the Mesenchymal Stem Cells market:

Injuries Drug Discovery Cardiovascular Infraction Others

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Geographically, the detailed analysis of consumption, revenue, market share and growth rate, historic and forecast (2016-2026) of the following regions are including,

The Research aims of the Mesenchymal Stem Cells Market report would be:

Major TOC points

1Mesenchymal Stem Cells Market Overview

1.1 Product Overview and Scope of Mesenchymal Stem Cells

1.2 Segment by Type

1.2.1 Global Sales Growth Rate Comparison by Type (2021-2026)

1.2.2 Type 1

1.2.3 Type 2

1.3 Segment by Application

1.3.1 Sales Comparison by Application: 2020 VS 2026

1.3.2 Application 1

1.3.3 Application 2

1.4 Global Market Size Estimates and Forecasts

1.4.1 Global Revenue 2016-2026

1.4.2 Global Sales 2016-2026

1.4.3 Mesenchymal Stem Cells Market Size by Region: 2020 Versus 2026

2 Global Mesenchymal Stem Cells Market Competition by Manufacturers

2.1 Global Sales Market Share by Manufacturers (2016-2020)

2.2 Global Revenue Share by Manufacturers (2016-2020)

2.3 Global Average Price by Manufacturers (2016-2020)

2.4 ManufacturersMesenchymal Stem Cells Manufacturing Sites, Area Served, Product Type

2.5 Market Competitive Situation and Trends

2.5.1 Mesenchymal Stem Cells Market Concentration Rate

2.5.2 Global Top 5 and Top 10 Players Market Share by Revenue

2.5.3 Market Share by Company Type (Tier 1, Tier 2, and Tier 3)

2.6 Manufacturers Mergers and Acquisitions, Expansion Plans

2.7 Primary Interviews with KeyMesenchymal Stem Cells Players (Opinion Leaders)

3 Mesenchymal Stem Cells Retrospective Market Scenario by Region

3.1 Global Mesenchymal Stem Cells Retrospective Market Scenario in Sales by Region: 2016-2020

3.2 Global Mesenchymal Stem Cells Retrospective Market Scenario in Revenue by Region: 2016-2020

3.3 North America Market Facts and Figures by Country

3.4 EuropeMesenchymal Stem Cells Facts and Figures by Country

3.5 Asia Pacific Market Facts and Figures by Region

3.6 Latin America Market Facts and Figures by Country

3.7 the Middle East and Africa Market Facts and Figures by Country

4 Global Mesenchymal Stem Cells Historic Market Analysis by Type

4.1 Global Sales Market Share by Type (2016-2020)

4.2 Global Revenue Market Share by Type (2016-2020)

4.3 Global Price Market Share by Type (2016-2020)

4.4 Global Market Share by Price Tier (2016-2020)

5 GlobalMesenchymal Stem Cells Historic Market Analysis by Application

5.1 Global Sales Market Share by Application (2016-2020)

5.2 Global Revenue Market Share by Application (2016-2020)

5.3 Global Price by Application (2016-2020)

..Countinued

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Server Motherboards Market Overview, Segmentation and Covid-19 Impact by 2026 | Foxconn, Gigabyte, HP and Others

Futuristic Reports

Name: Mark RiveraTel: +1-408-520-9037Email: [emailprotected]

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Mesenchymal Stem Cells Market to Witness Significant Rise in Revenue and Covid-19 Impact by 2026 | Celprogen Inc., Axol Bioscience Ltd., Stemedica...

Bone Marrow Stem Cells Comments Off on Mesenchymal Stem Cells Market to Witness Significant Rise in Revenue and Covid-19 Impact by 2026 | Celprogen Inc., Axol Bioscience Ltd., Stemedica… | November 8th, 2020

SOUTH SAN FRANCISCO, Calif., Nov. 06, 2020 (GLOBE NEWSWIRE) -- Atreca, Inc. (Atreca) (NASDAQ: BCEL), a biotechnology company focused on developing novel therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, today announced that it will participate in the following upcoming virtual investor conferences:

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Atreca to Present at Upcoming Virtual Investor Conferences

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Reported positive topline results for the ACROBAT Edge and Evolve Phase 2 trials of oral paltusotine for the treatment of acromegaly

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Crinetics Pharmaceuticals Reports Third Quarter 2020 Financial Results and Provides Corporate Update

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100% overall response rate in dose cohort 3 and 80% overall response rate across all cohorts to date

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Equillium Announces Positive Interim Data of Itolizumab in the First-line Treatment of Acute Graft-Versus-Host Disease

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– Pivotal Phase 3 safety and efficacy study AEZS-130-P02 (“Study P02”) expected to commence in Q1 2021

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Aeterna Zentaris Reports Third Quarter 2020 Financial Results and Provides Business Update

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JERSEY CITY, N.J., Nov. 06, 2020 (GLOBE NEWSWIRE) -- SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to potentially overcome and prevent difficult-to-treat and drug-resistant infections, today reported financial results for the third quarter ended on September 30, 2020 and provided an update on recent clinical and corporate developments.

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SCYNEXIS Reports Third Quarter 2020 Financial Results and Provides Company Update

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DOYLESTOWN, Pa., Nov. 06, 2020 (GLOBE NEWSWIRE) -- Kannalife, Inc. (“Kannalife” or the “Company”) (OTCQB: KLFE), a biopharmaceutical and medchem company specializing in the research and development of potent novel monotherapeutics, announced today that the Company has changed its official name to Neuropathix, Inc. (“Neuropathix”) with a new ticker symbol (OTCQB: NPTX).

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Kannalife, Inc. Rebrands as Neuropathix, Inc. and Unveils New Ticker Symbol

Global News Feed Comments Off on Kannalife, Inc. Rebrands as Neuropathix, Inc. and Unveils New Ticker Symbol | November 8th, 2020

Bagsværd, Denmark, 6 November 2020 — This document discloses the data of the transaction(s) made in Novo Nordisk shares by the company’s board members, executives and their associated persons in accordance with Article 19 of Regulation No. 596/2014 on market abuse.

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Trading in Novo Nordisk shares by board members, executives and associated persons on 4 and 5 November 2020

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DECLARATION OF THE NUMBER OF SHARES AND VOTING RIGHTS

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Virbac : Declaration of the number of shares and voting rights October 2020

Global News Feed Comments Off on Virbac : Declaration of the number of shares and voting rights October 2020 | November 8th, 2020

- Marked Reductions in Phe Observed at Two Doses -

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Homology Medicines Announces Presentation of Positive Data from the Dose-Escalation Phase of the pheNIX Gene Therapy Trial for Adults with PKU

Global News Feed Comments Off on Homology Medicines Announces Presentation of Positive Data from the Dose-Escalation Phase of the pheNIX Gene Therapy Trial for Adults with PKU | November 8th, 2020

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Tauriga Sciences, Inc. Experiencing Greater Market Acceptance for its Cannabis (CBD & CBG) Infused Chewing Gum Product Line

Global News Feed Comments Off on Tauriga Sciences, Inc. Experiencing Greater Market Acceptance for its Cannabis (CBD & CBG) Infused Chewing Gum Product Line | November 8th, 2020

MONTREAL, Nov. 06, 2020 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (Theratechnologies) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, today announced that an oral presentation including data on the mechanism of effect of tesamorelin in nonalcoholic fatty liver disease (NAFLD) will be given by Lindsay T Fourman, MD, of the Metabolism Unit, Department of Medicine, Massachusetts General Hospital, at The Liver Meeting® 2020 of the American Association for the Study of Liver Diseases (AASLD) to be held November 13-16, 2020.

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Theratechnologies Announces that Data on the Mechanism of Effect of Tesamorelin in NAFLD will be Presented at The Liver Meeting® 2020

Global News Feed Comments Off on Theratechnologies Announces that Data on the Mechanism of Effect of Tesamorelin in NAFLD will be Presented at The Liver Meeting® 2020 | November 8th, 2020

Summit Therapeutics Inc.(“Summit” or the “Company”)

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Summit Announces Closing of Private Placement of $50 Million

Global News Feed Comments Off on Summit Announces Closing of Private Placement of $50 Million | November 8th, 2020