FORT LAUDERDALE, Fla., Nov. 03, 2020 (GLOBE NEWSWIRE) -- Motus GI Holdings, Inc., (NASDAQ: MOTS) ("Motus GI" or the "Company"), a medical technology company providing endoscopy solutions to help improve clinical outcomes, is launching a new clinical protocol with NYU Langone Health to incorporate the Company’s Pure-Vu® GEN2 System (Pure-Vu) with the intention to improve the management of its inpatient colonoscopies.

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Motus GI and NYU Langone Health Partner to Improve its Inpatient Colonoscopy Management

Global News Feed Comments Off on Motus GI and NYU Langone Health Partner to Improve its Inpatient Colonoscopy Management | November 3rd, 2020

GAITHERSBURG, Md., Nov. 03, 2020 (GLOBE NEWSWIRE) -- Novavax, Inc. (Nasdaq: NVAX), a late stage biotechnology company developing next-generation vaccines for serious infectious diseases, today announced it will report its third quarter 2020 financial and operating results following the close of U.S. financial markets on Monday, November 9, 2020.

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Novavax to Host Conference Call to Discuss Third Quarter Financial and Operating Results on November 9, 2020

Global News Feed Comments Off on Novavax to Host Conference Call to Discuss Third Quarter Financial and Operating Results on November 9, 2020 | November 3rd, 2020

NEWTON, Mass., Nov. 03, 2020 (GLOBE NEWSWIRE) -- Allena Pharmaceuticals, Inc. (NASDAQ: ALNA), a late-stage, biopharmaceutical company dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders, today announced that company management will participate in three upcoming investor conferences in November:

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Allena Pharmaceuticals to Participate Virtually in Upcoming Investor Conferences in November

Global News Feed Comments Off on Allena Pharmaceuticals to Participate Virtually in Upcoming Investor Conferences in November | November 3rd, 2020

SAN DIEGO, Nov. 03, 2020 (GLOBE NEWSWIRE) -- TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., announced today that it will report its third quarter 2020 financial and operating results after the close of U.S. financial markets on Tuesday, November 10, 2020. In addition, management will host a conference call to provide an update on corporate activities and discuss the quarterly financial results.

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TRACON to Report Third Quarter 2020 Financial Results and Company Highlights on November 10, 2020

Global News Feed Comments Off on TRACON to Report Third Quarter 2020 Financial Results and Company Highlights on November 10, 2020 | November 3rd, 2020

CAMBRIDGE, United Kingdom, Nov. 03, 2020 (GLOBE NEWSWIRE) -- Abcam plc (AIM: ABC) (Nasdaq: ABCM), a global leader in the supply of life science research tools, announces that, following consultation with shareholders on the Group’s overall LTIP structure and performance framework, including proposed changes for this year’s awards, it has determined to retain the existing LTIP metrics and targets contained in Abcam’s current Remuneration Policy, as approved by shareholders in 2018.

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Abcam plc: Consultation on 2020 LTIP Awards

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MONMOUTH JUNCTION, N.J., Nov. 03, 2020 (GLOBE NEWSWIRE) -- Outlook Therapeutics, Inc. (Nasdaq: OTLK), a?late clinical-stage?biopharmaceutical company?working to develop the first FDA-approved ophthalmic formulation of bevacizumab-vikg for use in retinal indications, today announced the completion of patient enrollment for its planned open-label safety study evaluating ONS-5010/LYTENAVA™ (NORSE THREE). Patient enrollment for the study was completed in less than one month, significantly ahead of the planned four-month enrollment schedule.

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Outlook Therapeutics Completes Patient Enrollment of Open-Label Safety Study for ONS-5010/LYTENAVA™ (bevacizumab-vikg)

Global News Feed Comments Off on Outlook Therapeutics Completes Patient Enrollment of Open-Label Safety Study for ONS-5010/LYTENAVA™ (bevacizumab-vikg) | November 3rd, 2020

CAMBRIDGE, United Kingdom, Nov. 03, 2020 (GLOBE NEWSWIRE) -- Abcam plc (AIM: ABC) (Nasdaq: ABCM), a global leader in the supply of life science research tools, announces that, following release on 14 September 2020 of its final results for the year ended 30 June 2020, the Abcam plc Annual Report and Accounts 2020 (the “Annual Report”) have been published today and are available on the Abcam plc website at www.abcamplc.com.

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Abcam plc: Annual Report, Impact Report and Notice of AGM

Global News Feed Comments Off on Abcam plc: Annual Report, Impact Report and Notice of AGM | November 3rd, 2020

Live Webinar Featuring 3 KOLs Focused on Front and Back of the Eye Conditions and Opportunities for New Treatments on Monday, November 9, at 10:00am ET Live Webinar Featuring 3 KOLs Focused on Front and Back of the Eye Conditions and Opportunities for New Treatments on Monday, November 9, at 10:00am ET

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Ocuphire Pharma to Host Key Opinion Leader Event on Nyxol® and APX3330

Global News Feed Comments Off on Ocuphire Pharma to Host Key Opinion Leader Event on Nyxol® and APX3330 | November 3rd, 2020

SAN DIEGO, Nov. 03, 2020 (GLOBE NEWSWIRE) -- Progenity, Inc. (NASDAQ: PROG), a biotechnology company with an established track record of success in developing and commercializing molecular testing products, today announced that it will report third quarter 2020 financial results on Monday, November 9, 2020 after the close of financial markets. Progenity’s management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT that day to discuss the financial results and provide a corporate update.

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Progenity to Report Third Quarter 2020 Financial Results and Provide Corporate Update

Global News Feed Comments Off on Progenity to Report Third Quarter 2020 Financial Results and Provide Corporate Update | November 3rd, 2020

Bones make up the skeletal system and serve the important function of giving the body support to be able to move. Whats inside the bones also is essential to personal health.

Bone marrow can be found in the center of bones. According to the online wellness resource Healthline, this viscous or spongy tissue comes in two types: red or yellow bone marrow. Both have specific functions in the body.

Red bone marrow is essential for a process called hematopoiesis, or blood cell production. Hematopoietic stem cells in the red bone marrow can develop into key blood cells, including red blood cells, which carry oxygen-rich blood to the body; platelets, which help blood to clot; and white blood cells, which are involved in immune system responses.

Yellow bone marrow is involved with the storage of fats. These fats can be used as an energy source as needed. Yellow bone marrow also contains mesenchymal stem cells that can develop into bone, fat, muscle, or cartilage cells.

Over time, yellow bone marrow replaces red bone marrow in most of the bones in the adult body. Only a few bones, such as the pelvis, skull, vertebrae, and ribs, will contain red bone marrow into adulthood.

According to Medical News Today, bone marrow makes more than 200 billion new blood cells every day. Most blood cells in the body develop from bone marrow cells.

Issues with bone marrow can produce a host of side effects. Fatigue or weakness, fever, increased infections, easy bleeding and bruising, and specific conditions like leukemia and anemia can develop as a result of bone marrow-related problems. In some cases, a bone marrow transplant may be needed to replace diseased or nonfunctioning bone marrow. It also may help regenerate a new immune system that can fight leukemia or other cancers.

Bone marrow transplants also may involve replacing existing bone marrow with genetically healthy bone marrow to prevent future damage from certain genetic diseases, according to Medical News Today. Bone marrow transplants can come from ones own stem cells, a twin, a sibling, parent, or an unrelated donor. Marrow transplants also may come from stored umbilical cord blood.

Bone marrow is vital to the overall health and function of the human body. Bone marrow affects just about every other cell due to its unique relationship with blood production and immune function.

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The roles bone marrow plays in the body - Williston Daily Herald

Bone Marrow Stem Cells Comments Off on The roles bone marrow plays in the body – Williston Daily Herald | November 3rd, 2020

Only two decades ago, stem cell therapy was highly regulated in the United States and other countries but it was well underway in Hadassah Hospitals labs in Jerusalem. Never would we have imagined that the US expansion of one of the key clinical trials conducted in our labs in Israel would be later funded by Californias Stem Cell Institute.

In 2004, California had the foresight to advance this critical area of research, and Hadassah advocates played a major role in the passing of an unprecedented statewide ballot initiative that authorized state funding for stem cell research. This marked the passage of Proposition 71 in 2004.

Fast forward to today. Hadassahs commitment to stem cell research led the Californians for Stem Cell, Research, Treatments and Cures Initiative effort in 2020 to reach out for help with their grassroots effort to qualify the latest stem cell funding initiative for the November ballot. It qualified with your help, and I hope that in a few short weeks well be celebrating the passage of Proposition 14, which will provide $5.5 billion to help accelerate development of treatments and cures for life-threatening diseases and conditions.

The power of stem cells is mind-blowing: We are able to use these cells to replace damaged or diseased tissue, and in this way, treatments or cures for diseases like age-related macular degeneration, ALS, MS, Parkinsons, Alzheimers and diabetes could be a reality in the foreseeable future.

I come to this subject from a place of personal sorrow.

I watched my father-in-law, Irv, suffer for 12 and a half years with ALS, a man I loved as if he were my own father. He fought and fought, he made every minute of his battle meaningful, soaking as much life as he could, until he couldnt. Irv is the reason why I became involved in Hadassah because of their cutting-edge medical research and he is the reason that Im writing to you now.

Today, Hadassah is doing incredible things in stem cell research, and the stunning results of their clinical trials have riveted the worldwide medical community.

Of course, the research most personal to me is the ALS research. Hadassah researchers conducted the worlds first clinical trial using the patients own bone marrow stem cells to treat ALS.Pikuach nefesh, the preservation of life, is the most important obligation in Judaism, and the one that drives Hadassah. With the potential of stem research, we have the ability to save millions of lives throughout the world.

And, with the promise of stem cells, we can accelerate the development of treatments and cures for life-threatening diseases and conditions that affect someone in nearly half of all California families.

I believe that stem cell research is going to allow our children to look at the major diseases that plague our modern world the way we now view polio.That potential will not reveal itself on its own, nor did it with polio. It took decades of research and funding for a polio vaccine to be fully developed, tested and made available widely.

There are no medical miracles. Medical advancement happens because of research. Research takes will, knowledge, chutzpah and, of course, money. The path to get a therapy approved by the Food and Drug Administration can take 12 to 15 years, requires thousands of patients for clinical trials and costs billions of dollars. from life-saving vaccines, to pioneering cancer treatments, to the sequencing of the human genome.w When research stalls for lack of funding, opportunities are missed. Promising avenues go unexplored.

The passage of Proposition 14 would help to overcome those hurdles and create a streamlined process that delivers much-needed treatments to patients who have few options. How amazing would it be to be part of making medical history.I am so proud to be a member of Hadassah, which is not only leading the way in stem cell research but also doing its research in service to humanity. Together, we can make medical discoveries happen and continue to set the pace for the worldwide medical community.

I wish that my father-in-law was here to give you his final thumbs up.

Stacey Dorenfeld is the National State Advocacy Co-Chair and the Hadassah Southern California Advocacy Chair.

The views and opinions expressed in this article are the authors own and do not necessarily reflect those of the Forward.

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California Proposition 14 is about pikuach nefesh heres why - Forward

Bone Marrow Stem Cells Comments Off on California Proposition 14 is about pikuach nefesh heres why – Forward | November 3rd, 2020

Global Cell Banking Outsourcing Market: Overview

The global cell banking outsourcing market is likely to be driven by the rising demand for biopharmaceutical production targeting novel active sites, stem cell therapy, and gene therapy. A cell bank is a facility storing cells extracted from various organ tissue and body fluids so as to cater to the needs of the future. The cell banks make storage of cells with an elaborate characterization of the entire cell line as it reduces the possibilities of cross contamination. These benefits are estimated to fuel expansion of the global cell banking outsourcing market over the timeframe of assessment, from 2020 to 2030.

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Cell banking outsourcing industries engage testing, characterization, storage, and collection of tissues, cell lines, and the cells. These activities are done to assist in the production of biopharmaceuticals and in the research and development activities so as to ensure minimum adverse effects and high effectiveness. The procedure of the cell storage involves first proliferation of cells, which then multiplies in a huge number of identical cells and is then put inside cryovials safety for use in future. Cells are primarily utilized in the production of regenerative medicine. A surge in the number of cell banks together with the high demand for stem cell therapies is likely to work in favor of the global cell banking outsourcing market over the tenure of analysis, from 2020 to2030.

The global cell banking outsourcing market has been segmented on the basis of four important parameters, which are bank type, phase, cell type, and region.

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Global Cell Banking Outsourcing Market: Notable Developments

The global cell banking outsourcing market is considered a fairly competitive market and is marked with the presence of many leading market players. The companies in this market are forging mergers, partnerships, and collaborations so as to gain larger revenue and market share. The following development is expected to play an important role in the market:

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Global Cell Banking Outsourcing Market: Key Trends

The global cell banking outsourcing market is characterized by the presence of the following restraints, drivers, and opportunities.

High Demand for Stem Cell Therapies to Trigger Growth of the Market

The rising number of stem cell therapies across the globe primarily influences the global cell banking outsourcing market. According to a survey conducted by World Network for Blood and Marrow Transplantation (WBMN), nearly 1 million hematopoietic stem cell transplantation processes were conducted in between 2006 to 2014. These figure comprised removal of stem cells procedures from peripheral blood or bone marrow, proliferating, and then finally storing them cell banks for future use by patients. Stem cell therapies are able to multiple disease, such as amyotrophic lateral sclerosis, type 1 diabetes, cancer, Alzheimer's disease, Parkinson's disease, and so on. Ability to cure such a wide variety of diseases is expected to propel growth of the global cell banking outsourcing market in the years to come.

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Global Cell Banking Outsourcing Market: Geographical Analysis

North America is expected to dominate the global cell banking outsourcing market throughout the timeframe of analysis, from 2020 to 2030. Such high growth of the North America market is ascribed to the increased production of antibiotics, therapeutics protein, and vaccines. In addition, presence of several biopharmaceutical companies in the region is anticipated to foster growth of the cell banking outsourcing market in North America in the near future.

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Cell Banking Outsourcing Market: High Demand for Stem Cell Therapies to Trigger Growth of the Market - BioSpace

Bone Marrow Stem Cells Comments Off on Cell Banking Outsourcing Market: High Demand for Stem Cell Therapies to Trigger Growth of the Market – BioSpace | November 3rd, 2020

The Global Stem Cell Therapy Market report, published by Verified Market Research, is an extensive compilation of the essential aspects of the global Stem Cell Therapy market, assessed thoroughly by our team of researchers. The market intelligence report offers insightful data and information relevant to the market to acquaint the readers with the lucrative growth prospects existing in this industry, eventually helping them formulate effective business strategies. The global Stem Cell Therapy market report has been methodically curated using industry-verified data to offer information concerned with the leading manufacturers and suppliers engaged in this sector. It further focuses on their pricing analysis, gross revenue, product portfolio, sales network & distribution channels, profit margins, and financial standing.

Global Stem Cell Therapy Market was valued at USD 117.66 million in 2019 and is projected to reach USD 255.37 million by 2027, growing at a CAGR of 10.97% from 2020 to 2027.

The global Stem Cell Therapy market is highly consolidated due to the presence of a large number of companies across this industry. The report discusses the current market standing of these companies, their past performances, demand and supply graphs, production and consumption patterns, sales network, distribution channels, and growth opportunities in the market. Moreover, it highlights the strategic approaches of the key players towards expanding their product offerings and reinforcing their market presence.

The report covers extensive analysis of the key market players in the market, along with their business overview, expansion plans, and strategies. The key players studied in the report include:

The report further sheds light on the various strategic business initiatives undertaken by the key market contenders to fortify their foothold in this business sector. These strategies majorly include mergers & acquisitions, partnerships & collaborations, joint ventures, government and corporate deals, brand promotions, new product launches, and numerous others. In the later part of the report, the major components of the Stem Cell Therapy industry, such as product type, application gamut, end-use industries, and the solutions and services offered by the leading manufacturers, have been analyzed. Numerical data and subjective information pertaining to each market segment have been featured in the report for better understanding.

Therefore, the latest research document includes competitive analysis, key market players, crucial industry-related facts & figures, sales revenue, product prices, gross margins, market shares, business strategies, dominant regions, and key developments.

1.Stem Cell Therapy Market, By Cell Source:

Adipose Tissue-Derived Mesenchymal Stem Cells Bone Marrow-Derived Mesenchymal Stem Cells Cord Blood/Embryonic Stem Cells Other Cell Sources

2.Stem Cell Therapy Market, By Therapeutic Application:

Musculoskeletal Disorders Wounds and Injuries Cardiovascular Diseases Surgeries Gastrointestinal Diseases Other Applications

3.Stem Cell Therapy Market, By Type:

Allogeneic Stem Cell Therapy Market, By Application Musculoskeletal Disorders Wounds and Injuries Surgeries Acute Graft-Versus-Host Disease (AGVHD) Other Applications Autologous Stem Cell Therapy Market, By Application Cardiovascular Diseases Wounds and Injuries Gastrointestinal Diseases Other Applications

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The report encompasses the significant effects of the coronavirus pandemic on the Stem Cell Therapy market and its key segments. The report offers a vivid picture of the current market scenario, closely investigating the impact of the pandemic on this specific business sphere, its leading players, supply chains, distribution channels, and its global scenario. The pandemic has affected the global industry extensively, subsequently disrupting the Stem Cell Therapy market mechanism. Furthermore, the research study examines the Stem Cell Therapy market and the recent disruptive changes in the business setting that followed the outbreak. Also, the future effects of the pandemic on the market have been assessed in the report.

Key Geographies Encompassed in the Report:

North America (U.S., Canada)Europe (U.K., Germany, Italy, France, Rest of EU)Asia Pacific (India, Japan, China, Australia, Rest of APAC)Latin America (Brazil, Argentina, Rest of Latin America)Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of MEA)

Market Taxonomy:

Chapter 1: Methodology & Scope

Definition and forecast parametersMethodology and forecast parametersData Sources

Chapter 2: Executive Summary

Business trendsRegional trendsProduct trends

Chapter 3: Industry Insights

Industry segmentationIndustry landscapeVendor matrixTechnological and innovation landscape

Chapter 4: Regional Landscape

Chapter 5: Competitive Outlook

Company ProfileBusiness OverviewFinancial DataProduct LandscapeStrategic Outlook

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Advantages of the Stem Cell Therapy Market Report:

The report offers a clear description of the global Stem Cell Therapy market, containing the current market growth inclinations and future estimations to help businesses identify the potential investment areas.

The report covers the major market growth drivers, and constraints, alongside an extensive COVID-19 impact analysis.

The all-inclusive market feasibility reveals the profit-making trends to obtain a powerful foothold in the Stem Cell Therapy industry.

The SWOT analysis and Porters Five Forces Analysis explicate the effectiveness of the customers and providers from a global perspective.

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Verified Market Research is a leading Global Research and Consulting firm servicing over 5000+ customers. Verified Market Research provides advanced analytical research solutions while offering information enriched research studies. We offer insight into strategic and growth analyses, Data necessary to achieve corporate goals, and critical revenue decisions.

Our 250 Analysts and SMEs offer a high level of expertise in data collection and governance use industrial techniques to collect and analyze data on more than 15,000 high impact and niche markets. Our analysts are trained to combine modern data collection techniques, superior research methodology, expertise, and years of collective experience to produce informative and accurate research.

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Stem Cell Therapy Market To Exceed Revenues Worth US$ By The End Of 2020 2027 - Eurowire

Bone Marrow Stem Cells Comments Off on Stem Cell Therapy Market To Exceed Revenues Worth US$ By The End Of 2020 2027 – Eurowire | November 3rd, 2020

Global Hematopoietic Stem Cell Transplantation Market Report from AMA Research highlights deep analysis on market characteristics, sizing, estimates and growth by segmentation, regional breakdowns& country along with competitive landscape, players market shares, and strategies that are key in the market. The exploration provides a 360 view and insights, highlighting major outcomes of the industry. These insights help the business decision-makers to formulate better business plans and make informed decisions to improved profitability. In addition, the study helps venture or private players in understanding the companies in more detail to make better informed decisions.

Major Players in This Report Include,

Gilead Sciences Inc. (United States), Thermo Fisher Scientific (United States), PromoCell (Germany), CellGenix Technologie Transfer GmbH (Germany), Cesca Therapeutics Inc.(United States), R&D Systems (United States), Genlantis (United States), Lonza Group Ltd.(Switzerland), TiGenix N.V.(Belgium), ScienCell Research Laboratories (United States), Regen Biopharma Inc. (United States), China Cord Blood Corp (Hong Kong) and CBR Systems Inc. (United States).

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Analyst at AMA have conducted special survey and have connected with opinion leaders and Industry experts from various region to minutely understand impact on growth as well as local reforms to fight the situation. A special chapter in the study presents Impact Analysis of COVID-19 on Hematopoietic Stem Cell Transplantation Market along with tables and graphs related to various country and segments showcasing impact on growth trends.

Definition

Despite the increasing availability of smart antineoplastic therapies in recent years, Hematopoietic stem cell transplantation (HSCT) remains an optimal treatment modality for many hematologic malignancies. HSCT is one of a range of therapeutic options which is available to patients suffering from various diseases. It is a widely accepted treatment for many life-threatening diseases. The treatment is available to patients who suffer from refractory or relapsing neoplastic disease and non-neoplastic genetic disorders, as well as from chronic bone marrow failure. Hematopoietic stem cells are young or immature blood cells which are found to be living in bone marrow. These blood cells when matures in bone marrow very few enters into bloodstream.

Global Hematopoietic Stem Cell Transplantation Market Report offers a detailed overview of this market and discusses the dominant factors affecting the growth of the market. The impact of Porters five armies on the market over the next few years has been discussed for a long time in this study. We will also forecast global market size and market outlook over the next few years.

Types of Products, Applications and Global Hematopoietic Stem Cell Transplantation Market Report Geographical Scope taken as the Main Parameter for Market Analysis. This Research Report Conducts an assessment of the industry chain supporting this market. It also provides accurate information on various aspects of this market, such as production capacity, available production capacity utilization, industrial policies affecting the manufacturing chain and market growth.

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In this research study, the prime factors that are impelling the growth of the Global Hematopoietic Stem Cell Transplantation market report have been studied thoroughly in a bid to estimate the overall value and the size of this market by the end of the forecast period. The impact of the driving forces, limitations, challenges, and opportunities has been examined extensively. The key trends that manage the interest of the customers have also been interpreted accurately for the benefit of the readers.

The Hematopoietic Stem Cell Transplantation market study is being classified by Type, Applicationsand major geographies with country level break-up that includes South America (Brazil, Argentina, Rest of South America), Asia Pacific (China, Japan, India, South Korea, Taiwan, Australia, Rest of Asia-Pacific), Europe (Germany, France, Italy, United Kingdom, Netherlands, Rest of Europe), MEA (Middle East, Africa), North America (United States, Canada, Mexico).

The report concludes with in-depth details on the business operations and financial structure of leading vendors in the Global Hematopoietic Stem Cell Transplantation market report, Overview of Key trends in the past and present are in reports that are reported to be beneficial for companies looking for venture businesses in this market. Information about the various marketing channels and well-known distributors in this market was also provided here. This study serves as a rich guide for established players and new players in this market.

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Current Scenario Analysis for Decision Framework

Key Strategic Developments in Hematopoietic Stem Cell Transplantation Market:

The research includes the key strategic activities such as Research & Development (R&D) initiatives, Merger & Acquisition (M&A) completed, agreements, new launches, collaborations, partnerships & (JV) Joint ventures, and regional growth of the key competitors operating in the market at global and regional scale to overcome current slowdown due to COVID-19.

Key Market Features in Global Hematopoietic Stem Cell Transplantation Market

The report highlights Hematopoietic Stem Cell Transplantation market features, including revenue size, weighted average regional price, capacity utilization rate, production rate, gross margins, consumption, import & export, demand & supply, cost bench-marking in Hematopoietic Stem Cell Transplantation market share and annualized growth rate (Y-o-Y) and Periodic CAGR.

Extracts from Table of Contents

Global Hematopoietic Stem Cell Transplantation Market Research Report

Chapter 1 Global Hematopoietic Stem Cell Transplantation Market Overview

Chapter 2 Global Economic Impact on Industry

Chapter 3 Global Market Competition by Manufacturers

Chapter 4 Global Revenue (Value, Volume*) by Region

Chapter 5 Global Supplies (Production), Consumption, Export, Import by Regions

Chapter 6 Global Revenue (Value, Volume*), Price* Trend by Type

Chapter 7 Global Market Analysis by Application

.continued

This report also analyzes the regulatory framework of the Global Markets Hematopoietic Stem Cell Transplantation Market Report to inform stakeholders about the various norms, regulations, this can have an impact. It also collects in-depth information from the detailed primary and secondary research techniques analyzed using the most efficient analysis tools. Based on the statistics gained from this systematic study, market research provides estimates for market participants and readers.

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Hematopoietic Stem Cell Transplantation Market New Investments Expected to boost the Demand by 2025 - The Daily Philadelphian

Bone Marrow Stem Cells Comments Off on Hematopoietic Stem Cell Transplantation Market New Investments Expected to boost the Demand by 2025 – The Daily Philadelphian | November 3rd, 2020

The potential of gene therapies as cures for some hard-to-treat genetic diseases can be very attractive. But one such product is now suspected of causing a serious safety problem.

Friday, Orchard Therapeutics said its Strimvelis treatment, approved by European authorities in 2016 to treatthe rare inherited condition ADA-SCID, has been linked to a patients leukemia.

Preliminary findings suggest this diagnosis may be attributable to an insertional event related to treatment with Strimvelis, the company said. Its now investigating whether theres indeed a causal relationship.

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Since its 2016 EU approvalwhen it was owned by original developer GlaxoSmithKlineonly 16 patients have been treated with Stimvelis. The patient who developed leukemia had apparently been treated under a GSK compassionate use program in 2016.

No more patients will get the therapy before the investigation is complete, Orchard said. The drug was never approved in the U.S.

ADA-SCIDis a condition marked by a mutation in the gene making the adenosine deaminase (ADA) enzyme, which is essential for maintaining normal white blood cells. ADA-SCID patients, with a dysfunctional immune system, have less than two years to live without effective intervention.

RELATED:Orchard licenses gene therapy tech from GSK

Strimvelis, originally developed by GSK and bought by Orchard in 2018, offers an option for patients who cant find a matched stem cell donor. It works by editing the patients own hematopoietic stem cells with the functional ADA gene. The cells arethen transferred back into the patient's bone marrow to mature and produce the normal ADA protein.

The therapy uses a gammaretrovirus as the vector to carry the gene. Problem is, retrovirus can incorporate their own genetic information into the human genome, causing unintended changes that can give rise to cancer. It is a known risk factor of gammaretroviral vector-based gene therapy and has been described as one of the important potential risks for Strimvelis in its EU approval.

Besides Strimvelis, Orchard is also developing OTL-101, which uses a lentivirus to insert a functional copy of the ADA gene into a patients cells. The drug is currently undergoing a registrational trial and has won breakthrough and orphan drug designations from the FDA.

All the gene therapy candidates in Orchards pipeline use lentiviral vectors that have been specifically designed to avoid insertional oncogenesis after administration, Orchard said, adding that no dangerous gene insertion has been reported around lentiviral vector-based stem cell gene therapy in any indication.

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Orchard Therapeutics' gene therapy Strimvelis linked to a leukemia case - FiercePharma

Bone Marrow Stem Cells Comments Off on Orchard Therapeutics’ gene therapy Strimvelis linked to a leukemia case – FiercePharma | November 3rd, 2020

TEL AVIV, Israel, Oct. 30, 2020 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, today announced positive results from a planned interim analysis of the ongoing GENESIS Phase 3 trial of motixafortide for stem cell mobilization (SCM) in multiple myeloma patients.

At a meeting of the study's independent Data Monitoring Committee (DMC), a planned interim analysis of the study's primary endpoint was conducted independently by the DMC. Based on the statistically significant evidence favoring treatment with motixafortide, the DMC issued a recommendation to the Company that patient enrollment may be ceased immediately, without the need to recruit all 177 patients originally planned for the study.

In accordance with the DMC's recommendation, study enrollment is now complete at 122 patients. Full results for the study, including secondary and exploratory efficacy endpoints, as well as extended safety data, will be announced after the last patient enrolled reaches 100 days of follow-up post-transplantation, which is expected to occur in the first half of 2021.

"The compelling results of this planned interim analysis are a very significant milestone for our Company, as our SCM program is the Company's most efficient path to registration for motixafortide," stated Philip Serlin, Chief Executive Officer of BioLineRx. "Stem cell mobilization represents a significant unmet medical need in multiple myeloma, as between 50% and 70% of patients are poor mobilizers. We eagerly await the final results of the study, expected in the first half of next year, which we hope will support our goal of changing the treatment paradigm in autologous stem-cell mobilization, thus positioning motixafortide in combination with G-CSF as the new standard of care in this indication."

The GENESIS trial was initiated in December 2017. GENESIS is a randomized, placebo-controlled, multicenter study, evaluating the safety, tolerability and efficacy of motixafortide and G-CSF, compared to placebo and G-CSF, for the mobilization of HSCs for autologous transplantation in multiple myeloma patients. The primary objective of the study is to demonstrate that only one dose of motixafortide on top of G-CSF is superior to G-CSF alone in the ability to mobilize 6x106 CD34+ cells in up to two apheresis sessions. Secondary objectives include time to engraftment of neutrophils and platelets and durability of engraftment, as well as other efficacy and safety parameters.

About BioLineRx

BioLineRx Ltd. (NASDAQ/TASE: BLRX) is a late clinical-stage biopharmaceutical company focused on oncology. The Company's business model is to in-license novel compounds, develop them through clinical stages, and then partner with pharmaceutical companies for further clinical development and/or commercialization.

The Company's lead program, motixafortide (BL-8040), is a cancer therapy platform currently being evaluated in a Phase 2a study for the treatment of pancreatic cancer in combination with KEYTRUDA and chemotherapy under a collaboration agreement with MSD. Motixafortide is also being evaluated in a Phase 2b study in consolidation AML and a Phase 3 study in stem cell mobilization for autologous bone-marrow transplantation.

BioLineRx is developing a second oncology program, AGI-134, an immunotherapy treatment for multiple solid tumors that is currently being investigated in a Phase 1/2a study.

For additional information on BioLineRx, please visit the Company's website at http://www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events. BioLineRx industry updates are also regularly updated on Facebook,Twitter, and LinkedIn.

Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "may," "expects," "anticipates," "believes," and "intends," and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause BioLineRx's actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: the initiation, timing, progress and results of BioLineRx's preclinical studies, clinical trials and other therapeutic candidate development efforts; BioLineRx's ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials; BioLineRx's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of BioLineRx's therapeutic candidates; BioLineRx's ability to establish and maintain corporate collaborations; BioLineRx's ability to integrate new therapeutic candidates and new personnel; the interpretation of the properties and characteristics of BioLineRx's therapeutic candidates and of the results obtained with its therapeutic candidates in preclinical studies or clinical trials; the implementation of BioLineRx's business model and strategic plans for its business and therapeutic candidates; the scope of protection BioLineRx is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; estimates of BioLineRx's expenses, future revenues, capital requirements and its needs for additional financing; risks related to changes in healthcare laws, rules and regulations in the United States or elsewhere; competitive companies, technologies and BioLineRx's industry; risks related to the coronavirus outbreak; and statements as to the impact of the political and security situation in Israel on BioLineRx's business. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 12, 2020. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.

Contact:

Tim McCarthy LifeSci Advisors, LLC +1-212-915-2564 [emailprotected]

or

Moran Meir LifeSci Advisors, LLC +972-54-476-4945 [emailprotected]

SOURCE BioLineRx Ltd.

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BioLineRx Announces Positive Results from Interim Analysis of GENESIS Phase 3 Trial of Motixafortide (BL-8040) in Stem Cell Mobilization - PRNewswire

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Libmeldy TM Receives Positive CHMP Opinion for the Treatment of Early-Onset Metachromatic Leukodystrophy (MLD); U.S. IND Application on Track for Year End 2020

Cash and Investments of More Than $200M and Runway into 2022

Frontotemporal dementia (FTD) and Crohns Disease Preclinical Programs to be Featured in Virtual R&D Event on November 13, 2020

BOSTON and LONDON, Nov. 03, 2020 (GLOBE NEWSWIRE) -- Orchard Therapeutics (Nasdaq: ORTX), a global gene therapy leader, today reviewed recent business accomplishments and reported financial results for the quarter ended September 30, 2020.

The positive CHMP opinion we received last month for Libmeldy in the EU represents a proud moment for Orchard and offers a potentially transformative therapy for early-onset MLD patients and their families, said Bobby Gaspar, M.D., Ph.D., chief executive officer, Orchard Therapeutics. We are looking forward to many exciting developments for this program and the rest of our pipeline in the coming months, including our November investor event which will highlight our work in conditions with larger patient populations such as FTD and Crohns disease.

Recent Corporate Achievements

Planned Corporate Milestones

Seek regenerative medicine advanced therapy (RMAT) designation and file an investigational new drug (IND) application in U.S. by year-end 2020

Third Quarter 2020 Financial Results

Revenue from product sales of Strimvelis were $2.0 million for the third quarter of 2020 compared to $1.9 million in the same period in 2019, and cost of product sales were $0.7 million for the third quarter of 2020 compared to $0.6 million in the same period in 2019.

Research and development (R&D) expenses were $14.7 million for the third quarter of 2020 compared to $28.5 million in the same period in 2019. R&D expenses include the costs of clinical trials and preclinical work on the companys portfolio of investigational gene therapies, as well as costs related to regulatory, manufacturing, license fees and milestone payments under the companys agreements with third parties, and personnel costs to support these activities. The decline in R&D expenses is primarily attributable to the companys U.K. research and development tax credits, which are recorded as an offset to R&D expense. During the third quarter of 2020, the company recorded tax credits of $10.1 million as compared to $2.7 million in the same period in 2019. Further, the company has realized savings associated with an updated strategy and corporate restructuring previously announced in May 2020, including the consolidation of its R&D sites.

Selling, general and administrative expenses were $13.0 million for the third quarter of 2020 compared to $14.2 million in the same period in 2019. The decline was primarily due to lower administrative and corporate expenses as compared to the prior period, primarily resulting from the May 2020 corporate restructuring.

Net loss was $20.3 million for the third quarter of 2020 compared to $36.7 million in the same period in 2019. The lower net loss compared to the same period in 2019 is a result of the higher U.K. research and development tax credits, the savings associated with an updated strategic plan and corporate restructuring, and $5.5 million in other income primarily attributable to unrealized foreign currency gains in the quarter. The company had 97.7 million ordinary shares outstanding as of September 30, 2020.

Cash, cash equivalents and investments as of September 30, 2020, were $201.3 million compared to $325.0 million as of December 31, 2019. The decrease was primarily driven by cash used to fund operations for the nine months ended September 30, 2020. In the third quarter of 2020, the company received approximately $13.6 million of cash from R&D tax credits related to 2018 as a result of qualifying activities under the tax code in the U.K. The company expects that its existing cash, cash equivalents and investments will fund its anticipated operating and capital expenditure requirements into 2022. This excludes the $50 million expected to be available under the companys credit facility and any non-dilutive capital received from potential future partnerships or priority review vouchers.

Our European commercial team is in place and have executed the activities necessary to launch Libmeldy (if approved) on a country-by-country basis in the first half of 2021, said Frank Thomas, president and chief operating officer. In addition, we will be leveraging cross border reimbursement channels for the treatment of patients from other parts of the world based on our past experience with Strimvelis.

Webcast Information for November 13 R&D Investor Event

The company will be webcasting a virtual R&D investor event starting at 9:00 am ET on Friday, November 13, 2020. The event can be accessed under "News & Events" in the Investors & Media section of the company's website at http://www.orchard-tx.com, and a replay will be archived on the Orchard website following the event.

About Orchard

Orchard Therapeutics is a global gene therapy leader dedicated to transforming the lives of people affected by rare diseases through the development of innovative, potentially curative gene therapies. Our ex vivo autologous gene therapy approach harnesses the power of genetically modified blood stem cells and seeks to correct the underlying cause of disease in a single administration. In 2018, Orchard acquired GSKs rare disease gene therapy portfolio, which originated from a pioneering collaboration between GSK and theSan Raffaele Telethon Institute for Gene Therapy in Milan, Italy. Orchard now has one of the deepest and most advanced gene therapy product candidate pipelines in the industry spanning multiple therapeutic areas where the disease burden on children, families and caregivers is immense and current treatment options are limited or do not exist.

Orchard has its global headquarters in London and U.S. headquarters in Boston. For more information, please visit http://www.orchard-tx.com, and follow us onTwitter and LinkedIn.

Availability of Other Information About Orchard

Investors and others should note that Orchard communicates with its investors and the public using the company website (www.orchard-tx.com), the investor relations website (ir.orchard-tx.com), and on social media (Twitter and LinkedIn), including but not limited to investor presentations and investor fact sheets, U.S. Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that Orchard posts on these channels and websites could be deemed to be material information. As a result, Orchard encourages investors, the media, and others interested in Orchard to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Orchards investor relations website and may include additional social media channels. The contents of Orchards website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Forward-Looking Statements

This press release contains certain forward-looking statements about Orchards strategy, future plans and prospects, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may be identified by words such as anticipates, believes, expects, plans, intends, projects, and future or similar expressions that are intended to identify forward-looking statements. Forward-looking statements include express or implied statements relating to, among other things, Orchards business strategy and goals, including its plans and expectations for the regulatory approval and commercialization of Libmeldy, the therapeutic potential of Orchards product candidates, including Libmeldy and the other product candidates referred to in this release, Orchards expectations regarding the timing of regulatory submissions for approval of its product candidates, including the product candidates referred to in this release, the timing of interactions with regulators and regulatory submissions related to ongoing and new clinical trials for its product candidates, the timing of announcement of clinical data for its product candidates, the likelihood that such data will be positive and support further clinical development and regulatory approval of these product candidates, the likelihood of approval of such product candidates by the applicable regulatory authorities, and Orchards financial condition and cash runway into 2022. These statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, many of which are beyond Orchards control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, these risks and uncertainties include, without limitation: the risk that any one or more of Orchards product candidates, including the product candidates referred to in this release, will not be approved, successfully developed or commercialized; the risk of cessation or delay of any of Orchards ongoing or planned clinical trials; the risk that Orchard may not successfully recruit or enroll a sufficient number of patients for its clinical trials; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical studies or clinical trials will not be replicated or will not continue in ongoing or future studies or trials involving Orchards product candidates, including Libmeldy, will be insufficient to support regulatory submissions or marketing approval in the US and EU or that long-term adverse safety findings may be discovered; the delay of any of Orchards regulatory submissions; the failure to obtain marketing approval from the applicable regulatory authorities for any of Orchards product candidates, including the risk that our marketing authorization application submitted for Libmeldy may not be approved by the European Commission when expected, or at all, or the receipt of restricted marketing approvals; the inability or risk of delays in Orchards ability to commercialize its product candidates, including Libmeldy, if approved, including the risk that Orchard may not secure adequate pricing or reimbursement to support continued development or commercialization of Libmeldy; the risk that the market opportunity for its product candidates, including Libmeldy, may be lower than estimated; and the severity of the impact of the COVID-19 pandemic on Orchards business, including on clinical development, its supply chain and commercial programs. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements.

Other risks and uncertainties faced by Orchard include those identified under the heading "Risk Factors" in Orchards quarterly report on Form 10-Q for the quarter ended September 30, 2020, to be filed with the U.S. Securities and Exchange Commission (SEC), as well as subsequent filings and reports filed with the SEC. The forward-looking statements contained in this press release reflect Orchards views as of the date hereof, and Orchard does not assume and specifically disclaims any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

Condensed Consolidated Statements of Operations(In thousands, except share and per share amounts)(unaudited)

Condensed Consolidated Balance Sheet Data(In thousands)(unaudited)

Contacts

InvestorsRenee LeckDirector, Investor Relations+1 862-242-0764Renee.Leck@orchard-tx.com

MediaChristine Harrison VP, Corporate Affairs+1 202-415-0137media@orchard-tx.com

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Orchard Therapeutics Reviews Recent Portfolio Progress and Reports Third Quarter 2020 Financial Results - GlobeNewswire

Bone Marrow Stem Cells Comments Off on Orchard Therapeutics Reviews Recent Portfolio Progress and Reports Third Quarter 2020 Financial Results – GlobeNewswire | November 3rd, 2020

U.S. biotechnology company races to get its COVID-19 therapeutic approved for access, which has previously shownpositive results inseverely ill patients

Vancouver, WACytoDyn Inc. (CytoDyn) a late-stage biotechnology companydeveloping leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announcedit is currently accepting only 155 more candidates across the country for its Phase 2b/3 registrational trial in patients with severe-to-critical COVID-19.

CytoDyn is currently enrolling COVID-19 patients in its Phase 2b/3 clinical trial in at least 13 hospitals in nine states (California, Georgia, Massachusetts, New Jersey, New York, North Carolina, Ohio, Oregon and Texas). Please visit the Companys website atwww.cytodyn.com. The sites currently enrolling patients are listed on the home page under Clinical Trial Enrollment, then click on COVID-19 Severe or Critical in the drop-down screen. Please visit the website frequently, as the list of hospitals is updated on a regular basis.

CytoDyn has already enrolled 235 patients in its trial, and the Data Safety Monitoring Committee (DSMC) recently recommended CytoDyn continue its study without modification to achieve its primary endpoint, based on the results the DSMC observed so far.

The DSMC also added that it will look at the unblinded data again, once an additional 58 patients are enrolled.

We are very encouraged the DSMC recommended we continue our trial without modification, said Nader Pourhassan, Ph.D., President and CEO of CytoDyn.We believe this result, combined with the promising data already demonstrated with emergency INDs in over 60 severe and critical COVID-19 patients, is an indicator of positive data.

Its our hope this means our study is not only proving to be safe, but effective. If it wasnt, the DSMC would have stopped our trial or requested modifications.But instead, the DSMC recommended we continue our study without modification, and indicated it would look at the unblinded data once we are 75% enrolled.This, to us, is a very strong signal of positive data, added Pourhassan.

The recovery of a young woman in California provides some hopeful evidence of the effectiveness of leronlimab, Pourhassan said. She had contracted COVID-19 and was in the hospital on a ventilator. Within 24 hours after receiving a single injection of leronlimab, the amount of oxygen she needed started to drop, and 2 days later, she was able to be removed from her ventilator and later, sent home. She believes our drug saved her life.

We are optimistic and look forward to the completion of our study, or possible early evaluation to warrant an Emergency Use Authorization (EUA) from the FDA, Pourhassan concluded.

About Coronavirus Disease 2019

CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a double-blinded, randomized clinical trial for mild-to-moderate patients in the U.S. which produced statistically significant results for NEWS2. Enrollment continues in its Phase 2b/3 randomized clinical trial for the severe-to-critically ill COVID-19 population in several hospitals throughout the U.S.; an interim analysis on the first 195 patients was conducted mid-October.

CytoDyn is currently enrolling patients in its Phase 2b/3 COVID-19 trial for patients with severe-to-critical indications in at least 13 hospitals and clinics across the U.S., which are identified in this press release and on the Companys website under the Clinical Trial Enrollment section of the homepage.

About Leronlimab (PRO 140)

The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first indication is a combination therapy with 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 NASH.Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral 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 could 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 may play a role in tumor invasion, metastases, and tumor microenvironment control. 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 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial 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 CytoDyn

CytoDyn is a late-stage 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 critical 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 successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. The FDA met telephonically with Company key personnel and its clinical research organization and provided written responses to the Companys questions concerning its recent Biologics License Application (BLA) for this HIV combination therapy in order to expedite the resubmission of its BLA filing for this indication.

CytoDyn has completed 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. If successful, it 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. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than six years.

CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is atwww.cytodyn.com.

Forward-Looking Statements

This 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. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, including for patients with COVID-19, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain emergency use authorization or regulatory approval for leronlimab for commercial sales, and the market for actual commercial sales. The Companys 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 results of the Companys clinical trials, including the possibility of unfavorable clinical trial results,(ii) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Companys products, (iii) the market for, and marketability of, any product that is approved, (iv) the sufficiency of the Companys cash position, (v) the Companys ability to raise additional capital to fund its operations, (vi) the Companys ability to meet its debt obligations, if any, (vii) the Companys ability to enter into partnership or licensing arrangements with third parties, (viii) the Companys ability to identify patients to enroll in its clinical trials in a timely fashion, (ix) the Companys ability to achieve approval of a marketable product, (x) the design, implementation and conduct of the Companys clinical trials, ((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 Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-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 release.

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US biotechnology company races to get its COVID-19 therapeutic approved for access, which has previously shown positive results in severely ill...

Bone Marrow Stem Cells Comments Off on US biotechnology company races to get its COVID-19 therapeutic approved for access, which has previously shown positive results in severely ill… | November 3rd, 2020

Proposition 14 would authorize the sale of $5.5 billion in general obligation bonds for the California Institute for Regenerative Medicine, known as CIRM, for stem cell studies and trials.

Here is a rundown of the ballot measure:

In 2004, voters approved a bond measure to pay for stem cell research.

Now, with the money from that bond running out, supporters of the states stem cell agency are asking taxpayers for a new infusion of cash.

With interest, the bond could cost the state $260 million per year, or $7.8 billion over the next 30 years, according to the nonpartisan Legislative Analysts Office.

Proponents of Proposition 14 say the measure will help find new treatments and cures for chronic diseases and conditions, including cancers, spinal cord injuries, Alzheimers, Parkinsons and heart disease. They say the previous bond advanced research and treatments for more than 75 diseases, including two cancer treatments for fatal blood disorders that were approved by the U.S. Food and Drug Administration.

Without new funding to keep the program going, supporters of Proposition 14 say, groundbreaking medical discoveries and lifesaving research will be slowed or stopped.

Opponents say that the state shouldnt take on new debt while facing a pandemic-induced deficit and that medical advances attributed to the previous stem cell bond have been overstated. In addition, opponents say CIRM has been hampered by conflicts of interest and too little oversight, neither of which are remedied by the ballot measure.

The campaign to pass the 2004 ballot measure told voters that the bond would save millions of lives and cut healthcare costs by billions. Critics say thats not been the case to date, although supporters of this years measure note that they never intended those results within 16 years. While there is not much organized opposition, some newspaper editorial boards, including those at the Los Angeles Times and San Francisco Chronicle, have opposed it.

With Prop. 14, California voters will be asked for more borrowing to keep stem cell research going

Explaining Prop. 14

Times columnist George Skelton assesses Prop. 14

The California stem cell programs $5.5-billion funding request might be its downfall

Californias stem cell program faces an existential moment and a chance for reform

When it comes to disease, stem cells are a game-changer, scientists say. This is why

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California Prop. 14: What to know about the stem cell measure - Los Angeles Times

Spinal Cord Stem Cells Comments Off on California Prop. 14: What to know about the stem cell measure – Los Angeles Times | November 3rd, 2020

Professor Paul Glare at the Pain Management Research Institute.

Opioids are good for acute pain. With chronic pain they only work short to medium term, he says. But after about six months, you become tolerant and have to take bigger doses. Then theres the growing risk of accidental overdose, even accidental death.

For many people though, opioids seem like the only way to numb the pain that constantly attacks them. But do they in fact, numb the pain?

Most people who come off the long term use of opioids realise that the drugs werent doing that much, says Glare. Theyd already stopped working, so the pain without them is often no worse. In fact, the drugs were just messing with their heads. Still its a huge psychological step to let the drugs go.

Gently spoken and with a great sense of compassion for the people he works to help, Glare started his career in palliative care which took him into the area of cancer pain, then pain more generally. Because its difficult to tell people battling chronic pain that there is no satisfactory pharmaceutical answer at this time, the PMRI has a large and active pain education unit.

The Unit offers a Masters of Medicine Pain Management that is also conferred as a Masters of Science for non-medical graduates. It also runs cognitive behavioural therapy classes teaching strategies for rising above the pain.

The classes are challenging, says Glare. But many people who learn the self-management techniques can reduce or even stop their opioid use. Its about them not being afraid of their pain anymore.

Its the nature of chronic pain that the injury its warning you about, sometimes very loudly, isnt actually there. This can be seen in a persons posture as they sit and walk in a way that protects that non-injury. By gently confronting the pain, the person can eventually reclaim their normal posture and walk more confidently. Through that, they feel stronger within themselves and more in control of their pain.

The PMRI is now looking at digital support resources for people dealing with pain, Were developing an SMS based text messaging service and a more sophisticated chat-bot tool, to help people get over the hump of opioid tapering, says Glare. Its new in the pain world.

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How pain changes your brain - News - The University of Sydney

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