NEW YORK, Nov. 4, 2020 /PRNewswire/ --Actinium Pharmaceuticals, Inc.,(NYSE AMERICAN: ATNM) ("Actinium") today announced that two abstracts on the Company's Antibody Radiation Conjugate (ARC) Iomab-B were accepted for oral presentations at the 2020 American Society of Hematology (ASH) annual meeting that is being held virtually December 5-8, 2020.

"This is an exciting fourth quarter for the company and we are honored to have multiple oral presentations at this year's ASH conference. Our 3 oral presentations and one poster presentation demonstrate the clinical progress we have seen not only with Iomab-B, but our other programs including Actimab-A in combination with novel and approved therapeutic agents," stated Sandesh Seth, Actinium's Chairman and CEO. "We look forward to presenting the Iomab-B data in further detail during the two oral presentations on the Iomab-B SIERRA study at ASH in December. The company remains on track to report safety and feasibility data from 75% of the patients to be enrolled in SIERRA, as well as to complete the ad hoc interim analysis in the fourth quarter."

Mark Berger, Actinium's Chief Medical officer, said, "We are encouraged that we continue to see positive ongoing results from our Phase 3 pivotal SIERRA trial in relapsed or refractory Acute Myeloid Leukemia (R/R AML) patients. In the Iomab-B Phase 3 trial we continue to see 100% engraftment in patients receiving a therapeutic dose of Iomab-B in the treatment arm whereas 83% of control arm patients failed salvage therapy, which includes the recently approved targeting agents such as venetoclax. This high failure rate demonstrates the significant need that exists in R/R AML and represents the paradigm shift we are looking to initiate with Iomab-B. The strong safety and feasibility data we have seen thus far gives us confidence that these older patients with active AML may benefit by undergoing a potentially curative bone marrow transplant which they could not receive otherwise."

Details & Highlights for Oral Presentations

Note: The two abstractsincludeSIERRA Phase 3 trial data available to the company from its CRO prior to August 10, 2020, the ASH submission cutoff date. Per ASH rules, updated data sets are permitted to be included in the live presentations.

OralPresentationTitle:

Personalized Targeted Radioimmunotherapy with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] in Patients with Active Relapsed or Refractory Acute Myeloid Leukemia Results in Successful Donor Hematopoietic Cells Engraftment with the Timing of Engraftment Not Related to the Radiation Dose Delivered

Publication Number:

193

Session Name:

721. Clinical Allogeneic Transplantation: Conditioning Regimens, Engraftment, and Acute Transplant Toxicities

Session Date:

Saturday, December 5, 2020

Presentation Time:

1:00 PM PT / 4:00 PM ET

Phase 3 SIERRA Preliminary Results

Baseline Characteristics

Randomized to Iomab-B(N=53)

Randomized to Conventional Care (CC)(N=53)

Age (yrs, median, range)

64 (55-77)

65 (55-77)

Molecular & Cytogenetic Risk

Favorable: 2%Intermediate: 33%

Adverse: 65%

Favorable: 4%

Intermediate: 30%

Adverse: 66%

% TransplantedIntent-to-Treat Group

87% (46/53)

17% (9/53)

59% (26/44)

Results

Received Therapeutic dose of Iomab-B & Transplanted (N=46)****

Eligible to Receive Std. of Care Transplant Post-Salvage (N=9)

Evaluated for Crossover (N=44)*****

Cross-over Rate

n/a

n/a

Received Therapeutic Dose of Iomab-B (N=26)

Transplanted (N=26)

59% (26/44)

% Transplanted

100% (46/46)

17% (9/53)

100% (26/26)

BM Blast % @ baseline (median, range)

26 (4-95)

14 (5-97)

30 (6-87)

BM Blast % pre-HCT (median, range)

26 (4-95)

1 (0-3)*

32.5 (2-75)

Days to ANC Engraftment

14 (9-22)***

17 (13-83)#

14 (10-37)**

Days to Platelet Engraftment

17 (4-39)***

22 (8-35)#

19 (1-38)**

Days to HCT (Post Randomization)

30 (23-60)

66 (51-86)

65 (36-161)^

Myeloablative Dose Delivered to Bone Marrow

14.7 (4.6-32) Gv

n/a

14.4 (6.3-30) Gv

540 (313-1008) mCi

632 (354-1027) mCi

Chimerism>/=95% by D100

91% (39/43^ Evaluable)

67% (4/6^^ Evaluable)

87% (20/23^^^ Evaluable)

100-day non-Relapse Transplant-Related Mortality

5% (2/40 Evaluable)

25% (2/8 Evaluable)

8% (2/24 Evaluable)

*1 pt with 8% BM blasts on D42 with CRp on D50, ** ANC engraftment data not available (N=3), platelet engraftment data not available (N=4); *** ANC engraftment data not available (N=4), platelet engraftment data not available (N=9), ^ 1 patient at 161 days had delayed transplant due to infection and respiratory failure, received Iomab & transplant when stable, # ANC and platelet engraftment data not available (N=2)

**** No Therapy Dose (7) due to: Declining KPS (4), Infusion Reaction (1), Unfavorable Biodistribution (1), Post-Randomization Eligibility (1); 1 Pending Treatment.

*****Ineligible for Iomab-B HCT after crossover evaluation - 13: due to Hospice Care/Progression (4), Declined/Ineligible for HCT (5), Died Pre-Crossover (4). 4 Received Dosimetry but No Therapy Dose due to Declining KPS; 2 Pending Evaluation for Crossover.

^ Did not achieve 95% chimerism (4); Data pending (2); Died (1); ^^ Did not achieve 95% chimerism (4); Data pending (1); ^^^Did not achieve 95% chimerism (4); Data pending (2);

Oral PresentationTitle:

High Doses of Targeted Radiation with Anti-CD45 Iodine (131I) Apamistamab [Iomab-B] Do Not Correlate with Incidence of Mucositis, Febrile Neutropenia or Sepsis in the Prospective, Randomized Phase 3 Sierra Trial for Patients with Relapsed or Refractory Acute Myeloid Leukemia

Publication Number:

135

Session Name:

721. Clinical Allogeneic Transplantation: Conditioning Regimens, Engraftment, and Acute Transplant Toxicities

Session Date:

Saturday, December 5, 2020

Presentation Time:

9:30 AM PT / 12:30 PM ET

Continue reading here:
Actinium Announces Two Oral Presentations Featuring Data and Findings from the Phase 3 SIERRA Trial of Iomab-B at the 62nd American Society of...

Bone Marrow Stem Cells Comments Off on Actinium Announces Two Oral Presentations Featuring Data and Findings from the Phase 3 SIERRA Trial of Iomab-B at the 62nd American Society of… | November 5th, 2020

Stem Cell Therapy Market Size And Forecast

A comprehensive overview of the Stem Cell Therapy Market is recently added by Verified Market Research to its humongous database. Furthermore, the Stem Cell Therapy Market report has been aggregated by collecting informative data of various dynamics such as market drivers, restraints, and opportunities. Furthermore, this innovative report makes use of SWOT, PESTLE, and Porters Five Forces analyses to get a closer outlook on the Stem Cell Therapy Market. Furthermore, the Stem Cell Therapy Market report offers a detailed analysis of the latest industry developments and trending factors in the market that are influencing the market growth. Furthermore, this statistical market research repository examines and estimates the Stem Cell Therapy Market at the global and regional levels. The study covers the impact of various drivers and manacles on the Stem Cell Therapy Market growth opportunities over the forecast period.

Impact of Covid-19 :

During the first quarter of 2020, different global economies were badly impacted by a viral outbreak of COVID-19. This viral outbreak of the Covid-19 was later recognized as a global pandemic by the World Health Organization (WHO). COVID-19 spread in different global countries, affecting a large number of people in a short timeframe. The outburst of COVID-19 adversely hit different global economies in the world. The stringent regulations imposed by several governments, including complete lockdown and quarantine methodologies to fight against COVID-19, resulted in a massive impact on various business sectors. We at Verified Market Research offer an informative report on the Stem Cell Therapy Market which helps in making strategic decisions over the forecast period.

Competitive Landscape:

The degree of competition among leading global companies has been elaborated by examining various leading key players operating across the global regions An expert team of research analysts sheds light on various attributes such as -global market competition, market share, latest industry developments, innovative product launches, partnerships, mergers or acquisitions by leading companies in the Stem Cell Therapy Market. The leading manufacturers have been analyzed by using research methodologies for getting insight views on global competition.

Following key players have been profiled with the help of proven research methodologies:

The Stem Cell Therapy Market has been examined into different global market segments such as type, applications and global geographies. Each and every global market segment has been studied to get informative insights into various global regions.

Global Stem Cell Therapy Market Segmentation:

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

Global Stem Cell Therapy Market Segment by Global Presence:

North America Latin America Middle East Asia-Pacific Africa Europe

The report has been aggregated by using a couple of research methodologies such as primary and secondary research techniques. It helps in collecting informative pieces of professional information for deriving effective insights into the market. This informative report helps in making well informed and strategic decisions throughout the forecast period.

Key questions answered through this analytical market research report include:

What are the latest trends, new patterns and technological advancements in the Stem Cell Therapy Market? Which factors are influencing the Stem Cell Therapy Market over the forecast period? What are the global challenges, threats and risks in the Stem Cell Therapy Market? Which factors are propelling and restraining the Stem Cell Therapy Market? What are the demanding global regions of the Stem Cell Therapy Market? What will be the global market size over the coming future? What are the different effective business strategies followed by global companies?

If you have any custom requirements, please let us know and we will offer you the customized report as per your requirements.

About Us:

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.

Contact us:

Mr. Edwyne Fernandes

US: +1 (650)-781-4080UK: +44 (203)-411-9686APAC: +91 (902)-863-5784US Toll-Free: +1 (800)-7821768

Email: sales@verifiedmarketresearch.com

Read the original here:
Stem Cell Therapy Market Size, Key Development Trends, and Growth Projection to 2027 - Stock Market Vista

Bone Marrow Stem Cells Comments Off on Stem Cell Therapy Market Size, Key Development Trends, and Growth Projection to 2027 – Stock Market Vista | November 5th, 2020

The ability to grow and reproduce is a fundamental property of living organisms. Whether an organism is composed of a single cell or trillions of cells, individual cells must be able to grow and divide in an appropriately regulated fashion.

Cell growth is accomplished through the synthesis of new molecules of proteins, nucleic acids, carbohydrates and lipids. As the accumulation of these molecules causes the volume of a cell to increase, the plasma membrane grows to prevent the cell from burst-ing.

But cells cannot continue to enlarge indefinitely; as a cell grows larger, there is an accompanying decrease in its surface area/volume ratio and hence in its capacity for ef-fective exchange with the environment.

Therefore, cell growth is generally accompanied by cell division, whereby one cell gives rise to two new daughter cells (The term daughter is used by convention and does not indicate that cells have gender).

For single-celled organisms, cell division increases the total number of individuals in a population. In multicellular organisms, cell division either increases the number of cells, leading to growth of the or-ganism, or replaces cells that have died. In an adult human, for example, about two million stem cells in bone marrow divide every second to maintain a constant num-ber of red blood cells in the body. When cells grow and divide, the newly formed daugh-ter cells are usually genetic duplicates of the parent cell, containing the same (or virtually the same) DNA sequences.

Therefore, all the genetic information in the nucleus of the parent cell must be duplicated and carefully distributed to the daughter cells during the division process.

In accomplishing this task, a cell passes through a series of discrete stages, collectively known as the cell cycle. The cell cycle begins when two new cells are formed by the division of a single parental cell and ends when one of those cells divides again into two cells.

To early cell biologists studying eukaryotic cells with the mi-croscope, the most dramatic events in the life of a cell were those associated with the point in the cycle when the cell actually divides. This division process, called the M phase, involves two overlapping events in which the nucleus divides first and the cytoplasm second. Nuclear division is called mitosis, and the division of the cytoplasm to pro-duce two daughter cells is termed cytokinesis.

The stars of the mitotic drama are the chromosomes.

The beginning of mitosis is marked by condensation (coiling and folding) of the cells chromatin, which generates chromosomes that are thick enough to be individually discernible under the micro-scope.

Because DNA replication has already taken place, each chromosome actually consists of two chromosome copies that remain attached to each other until the cell divides. As long as they remain attached, the two new chromosomes are referred to as sister chromatids.

As the chromatids become visible, the nuclear envelope breaks into fragments. Then, in a stately ballet guided by the mi-crotubules of the mitotic spindle, the sister chromatids separate and each now a full-fledged chromosome move to opposite ends of the cell.

By this time, cytokinesis has usually begun, and new nuclear membranes envelop the two groups of daughter chromosomes as cell division is completed. While visually striking, the events of the mitotic phase account for a relatively small portion of the total cell cycle; for a typical mammalian cell, the mitotic phase usually lasts less than an hour.

Cells spend the majority of their time in the growth phase between divisions, called interphase. Most cellular contents are synthesised continuously during interphase, so cell mass gradually increases as the cell approaches division.

During interphase the amount of nuclear DNA doubles, and experiments using radioactive DNA precursors have shown that the new DNA is synthesised during a particular portion of interphase named the S phase (S for synthesis). A time gap called G1 phase separates the S phase from the preceding M phase, and a second gap, the G2 phase, separates the end of S phase from the beginning of the next M phase.

Although the cells of a multicellular organism divide at varying rates, most studies of the cell cycle involve cells growing in culture, where the length of the cycle tends to be similar for different cell types. We can easily determine the overall length of the cell cycle the generation time for cultured cells by counting the cells under a microscope and determining how long it takes for the population to double.

In cultured mammalian cells, for example, the total cycle usually takes about 18-24 hours. Once we know the total length of the cycle, it is possible to determine the length of specific phases. To determine the length of the S phase, we can expose cells to a radioactively labelled DNA precursor for a short period of time and then examine the cells by autoradiography.

The fraction of cells with silver grains over their nuclei represents the fraction of cells that were somewhere in S phase when the radioactive compound was available. When we mul-tiply this fraction by the total length of the cell cycle, the result is an estimate of the average length of the S phase.

For mammalian cells in culture, this fraction is often around 0.33, which indicates that S phase is about six to eight hours in length. Similarly, we can estimate the length of the M phase by multiplying the generation time by the percentage of the cells that are actually in mitosis at any given time.

This percentage is called the mitotic index.

The mitotic index for cultured mammalian cells is often about three to five per cent, which means that M phase lasts less than an hour (usually 30-45 minutes). In contrast to the S and M phases, whose lengths tend to be quite similar for different mammalian cells, the length of G1 is quite variable, depending on the cell type. Although a typical G1 phase lasts 8-10 hours, some cells spend only a few minutes or hours in Gl, whereas others are delayed for long periods of time. During Gl, a major decision is made as to whether and when the cell is to divide again. Cells that become arrested in Gl, awaiting for a signal that will trigger re-entry into the cell cycle and a commitment to divide, are said to be in G0 (G zero).

Other cells exit from the cell cycle entirely and undergo terminal differentiation, which means that they are destined never to divide again; most of the nerve cells in our body are in this state. In some cells, a transient arrest of the cell cycle can also occur in G2. In general, however, G2 is shorter than Gl and is more uniform in duration among different cell types, usually lasting 4-6 hours.

The writer is associate professor and head, department of botany, Ananda Mohan College, Kolkata.

Go here to read the rest:
Putting it all together - The Statesman

Bone Marrow Stem Cells Comments Off on Putting it all together – The Statesman | November 5th, 2020

NEW YORK, Nov. 4, 2020 /PRNewswire/ -- Aruvant Sciences, a private company focused on developing gene therapies for rare diseases, announced that an abstract demonstrating clinical benefit of the company's lead product candidate ARU-1801 has been published online and will be the subject of an oral presentation at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition. The meeting will take place virtually from December 5 to 8. Michael S. Grimley, M.D., Professor of Clinical Pediatrics, Medical Director of the Division of Bone Marrow Transplantation and Immune Deficiency at the Cincinnati Children's Hospital Medical Center, will present the data at 2:15 PM ET on December 7, 2020. Today the abstract was published online and will be published in the upcoming supplemental issue of Blood.

Data presented at ASH is from the MOMENTUM study, an open label Phase 1/2 clinical trial examining ARU-1801 as a one-time potentially curative gene therapy for individuals with sickle cell disease (SCD). The MOMENTUM study, which continues to enroll patients, examines ARU-1801, an autologous cell therapy leveraging a modified gamma globin lentivirus vector, in individuals with severe SCD. Unlike investigational gene therapies that require fully myeloablative conditioning, ARU-1801 is given with reduced intensity conditioning (RIC), which is a lower dose chemotherapy. ARU-1801 is designed to address the limitations of current curative treatment options, such as low donor availability and the risk of Graft-versus-Host Disease (GvHD) seen with allogeneic stem cell transplants. The data to be presented at ASH highlights participants dosed with product manufactured with both the original academic manufacturing process and the enhanced Process II.

"The clinical results thus far demonstrate that ARU-1801 holds significant promise for achieving durable responses with a reduced intensity conditioning approach to gene therapy," said Dr. Grimley, a principle investigator in the MOMENTUM study. "Given the impact chemotherapy toxicity has on physician and patient decision making around treatment options, ARU-1801 has the potential to be a unique option for SCD patients seeking gene therapy."

Abstract and Oral Presentation Information

Title: Early Results from a Phase 1/2 Study of ARU-1801 Gene Therapy for Sickle Cell Disease (SCD): Manufacturing Process Enhancements Improve Efficacy of a Modified Gamma Globin Lentivirus Vector and Reduced Intensity Conditioning TransplantPublication Number: 680Session Name: 114. Hemoglobinopathies, Excluding ThalassemiaClinical: Novel Treatments for Sickle Cell DiseaseDate:Monday, December 7, 2020Session Time:1:30 PM - 3:00 PMPresentation Time:2:15 PM

About ARU-1801ARU-1801 is a one-time potentially curativeinvestigational gene therapy for individuals living with sickle cell disease. This product candidate was designed to address the limitations of current treatment options including chemotherapy toxicity, donor availability, andchronic administration and replace it with a curative therapy. ARU-1801 incorporates a patented modified gamma-globin into autologous stem cells, with the aim of restoring normal red blood cell function through increased levels of fetal hemoglobin. The high potency of the modified gamma globin enables ARU-1801 engraftment with only reduced intensity conditioning (RIC). Preliminary clinical data from the MOMENTUMstudy, an ongoing Phase 1/2 trial in patients with sickle cell disease, demonstrate continuing durable reductions in disease burden.

The MOMENTUM StudyAruvant is currently conducting the MOMENTUM study, which is evaluating ARU-1801, a one-time only potentially curative gene therapy for patients with SCD. This Phase 1/2 study currently is enrolling individuals with SCD, and information may be found at http://www.momentumtrials.com.

About Aruvant SciencesAruvant Sciences, part of the Roivant family of companies, is a clinical-stage biopharmaceutical company focused on developing and commercializing gene therapies for the treatment of rare diseases. The company has a talentedteamwith extensive experience in the development, manufacturing and commercialization of gene therapy products. Aruvant has an activeresearchprogram with a lead product candidate, ARU-1801, in development for individuals suffering fromsickle cell disease(SCD). ARU-1801 is an investigational lentiviral gene therapy currently in aclinical trial,the MOMENTUM study, as a potential one-time curative treatment for SCD. Preliminary clinical data from the ongoing Phase 1/2 study demonstrated engraftment of ARU-1801 and amelioration of SCD is possible with one dose of low intensity chemotherapy. For more information on the clinical study, please visit http://www.momentumtrials.com and for more on the company, please visitwww.aruvant.com.

SOURCE Aruvant Sciences

Index

The rest is here:
Aruvant Announces Updated Data to be Presented in Oral Presentation of ARU-1801 Data at the 62nd American Society of Hematology (ASH) Annual Meeting -...

Bone Marrow Stem Cells Comments Off on Aruvant Announces Updated Data to be Presented in Oral Presentation of ARU-1801 Data at the 62nd American Society of Hematology (ASH) Annual Meeting -… | November 5th, 2020

NEW YORK, Nov. 04, 2020 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, reminds investors that class actions have been commenced on behalf of stockholders of Precigen, Inc. f/k/a Intrexon Corporation (NASDAQ: PGEN; XON), Royal Caribbean Group (NYSE: RCL), Mesoblast Limited (NASDAQ: MESO), and Loop Industries, Inc. (NASDAQ: LOOP). Stockholders have until the deadlines below to petition the court to serve as lead plaintiff. Additional information about each case can be found at the link

Precigen, Inc. f/k/a Intrexon Corporation (NASDAQ: PGEN; XON)

Class Period: May 10, 2017 to September 25, 2020

Lead Plaintiff Deadline: December 4, 2020

On September 25, 2020, the U.S. Securities and Exchange Commission (SEC) issued a cease and desist order against Precigen. The cease and desist order involved inaccurate reports concerning the companys purported success converting relatively inexpensive natural gas into more expensive industrial chemicals using a proprietary methane bioconversion (MBC) program. The order noted that the Company was primarily using significantly more expensive pure methane for the relevant laboratory experiments but was indicating that the results had been achieved using natural gas. The cease-and-desist order further stated that although the Company pitched the MBC program privately to numerous potential business partners over the course of 2017 and 2018 and [a] number of these potential partners performed due diligence on the MBC program including reviewing lab results and plans for commercialization. [The Company] has not yet found a partner for the MBC program.

The complaint, filed on October 5, 2020, alleges that throughout the Class Period defendants made false and/or misleading statements and/or failed to disclose to investors that: (1) the Company was using pure methane as feedstock for its announced yields for its methanotroph bioconversion platform instead of natural gas; (2) yields from natural gas as a feedstock were substantially lower than the aforementioned pure methane yields; (3) due to the substantial price difference between pure methane and natural gas, pure methane was not a commercially viable feedstock; (4) the Companys financial statements for the quarter ended March 31, 2018 were false and could not be relied upon; (5) the Company had material weaknesses in its internal controls over financial reporting; (6) the Company was under investigation by the SEC since October 2018; and (7) as a result of the foregoing, defendants public statements were materially false and misleading at all relevant times.

For more information on the Precigen class action go to: https://bespc.com/cases/PGEN

Royal Caribbean Group (NYSE: RCL)

Class Period: February 4, 2020 to March 17, 2020

Lead Plaintiff Deadline: December 7, 2020

The complaint, filed on October 7, 2020, alleges that throughout the Class Period defendants failed to disclose material facts about the Companys decrease in bookings outside China, instead maintaining that it was only experiencing a slowdown in bookings from China. The Action further alleges that defendants failed to disclose material facts about the Companys inadequate policies and procedures to prevent the spread of COVID-19 on its ships. The truth about the scope of the impact that COVID-19 had on the Companys overall bookings and the inability of Royal Caribbean to prevent the virus spread on its ships was revealed through a series of disclosures.

First, on February 13, 2020, Royal Caribbean issued a press release stating that it had canceled 18 voyages in Southeast Asia due to recent travel restrictions and further warning that recent bookings had been softer for its broader business.

On this news, Royal Caribbean shares fell over 3 percent.

Second, on February 25, 2020, Royal Caribbean filed its 2019 Form 10-K, indicating that COVID-19 concerns were negatively impacting its overall business.

On this news, Royal Caribbean shares fell over 14 percent.

Third, on March 10, 2020, Royal Caribbean withdrew its 2020 financial guidance, increased its revolving credit facility by $550 million, and announced that it would take cost-cutting actions due to the proliferation of COVID-19, further revealing that COVID-19 was severely impacting Royal Caribbeans 2020 customer booking and that its safety measures were inadequate to prevent the spread of the virus on its ships.

On this news, Royal Caribbean shares fell over 14 percent.

Fourth, on March 11, 2020, Royal Caribbeans largest competitor, Carnival, announced a 60-day suspension of all operations, prompting concern that Royal Caribbean would follow suit. At the same time, Royal Caribbean also cancelled two cruises, beginning a series of cancellations and suspensions to follow.

On this news, Royal Caribbean shares fell almost 32 percent.

Fifth, on March 14, 2020, Royal Caribbean announced a suspension of all global cruises for 30 days.

On this news, Royal Caribbean stock fell over 7 percent.

Sixth, on March 16, 2020, the Company revealed that global operations could be suspended longer than anticipated, announcing the cancellations of two additional cruises throughout April and into May.

On this news, Royal Caribbean shares fell over 7 percent.

Finally, on March 18, 2020, analysts downgraded Royal Caribbeans stock and slashed their price targets.

On this news, Royal Caribbean shares fell more than 19 percent.

For more information on the Royal Caribbean class action go to: https://bespc.com/cases/RCL

Mesoblast Limited (NASDAQ: MESO)

Class Period: April 16, 2019 to October 1, 2020

Lead Plaintiff Deadline: December 7, 2020

Mesoblast develops allogeneic cellular medicines using its proprietary mesenchymal lineage cell therapy platform. Its lead product candidate, RYONCIL (remestemcel-L), is an investigational therapy comprising mesenchymal stem cells derived from bone marrow. In February 2018, the Company announced that remestemcel-L met its primary endpoint in a Phase 3 trial to treat children with steroid refractory acute graft versus host disease (aGVHD).

In early 2020, Mesoblast completed its rolling submission of its Biologics License Application (BLA) with the FDA to secure marketing authorization to commercialize remestemcel-L for children with steroid refractory aGVHD.

On August 11, 2020, the FDA released briefing materials for its Oncologic Drugs Advisory Committee (ODAC) meeting to be held on August 13, 2020. Therein, the FDA stated that Mesoblast provided post hoc analyses of other studies to further establish the appropriateness of 45% as the null Day-28 ORR for its primary endpoint. The briefing materials stated that, due to design differences between these historical studies and Mesoblasts submitted study, it is unclear that these study results are relevant to the proposed indication.

On this news, the Companys share price fell $6.09, or approximately 35%, to close at $11.33 per share on August 11, 2020.

On October 1, 2020, Mesoblast disclosed that it had received a Complete Response Letter (CRL) from the FDA regarding its marketing application for remestemcel-L for treatment of SR-aGVHD in pediatric patients. According to the CRL, the FDA recommended that the Company conduct at least one additional randomized, controlled study in adults and/or children to provide further evidence of the effectiveness of remestemcel-L for SR-aGVHD. The CRL also identified a need for further scientific rationale to demonstrate the relationship of potency measurements to the products biologic activity.

On this news, the Companys share price fell $6.56, or 35%, to close at $12.03 per share on October 2, 2020.

The complaint, filed on October 8, 2020, alleges that throughout the Class Period defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Companys business, operations, and prospects. Specifically, defendants failed to disclose to investors: (1) that comparative analyses between Mesoblasts Phase 3 trial and three historical studies did not support the effectiveness of remestemcel-L for steroid refractory aGVHD due to design differences between the four studies; (2) that, as a result, the FDA was reasonably likely to require further clinical studies; (3) that, as a result, the commercialization of remestemcel-L in the U.S. was likely to be delayed; and (4) that, as a result of the foregoing, defendants positive statements about the Companys business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

For more information on the Mesoblast class action go to: https://bespc.com/cases/MESO

Loop Industries, Inc. (NASDAQ: LOOP)

Class Period: September 24, 2018 to October 12, 2020

Lead Plaintiff Deadline: December 14, 2020

On October 13, 2020, Hindenburg Research published a report alleging, among other things, that Loops scientists, under pressure from CEO Daniel Solomita, were tacitly encouraged to lie about the results of the companys process internally. The report also stated that Loops previous claims of breaking PET down to its base chemicals at a recovery rate of 100% were technically and industrially impossible, according to a former employee. Moreover, the report alleged that Executives from a division of key partner Thyssenkrupp, who Loop entered into a global alliance agreement with in December 2018, told us their partnership is on indefinite hold and that Loop underestimated both costs and complexities of its process.

On this news, the Companys share price fell $3.78, or over 32%, to close at $7.83 per share on October 13, 2020.

The complaint, filed on October 13, 2020, alleges that throughout the Class Period defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Companys business, operations, and prospects. Specifically, defendants failed to disclose to investors: (1) that Loop scientists were encouraged to misrepresent the results of Loops purportedly proprietary process; (2) that Loop did not have the technology to break PET down to its base chemicals at a recovery rate of 100%; (3) that, as a result, the Company was unlikely to realize the purported benefits of Loops announced partnerships with Indorama and Thyssenkrupp; and (4) that, as a result of the foregoing, defendants positive statements about the Companys business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

For more information on the Loop class action go to: https://bespc.com/cases/Loop

About Bragar Eagel & Squire, P.C.:Bragar Eagel & Squire, P.C. is a nationally recognized law firm with offices in New York and California. The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country. For more information about the firm, please visit http://www.bespc.com. Attorney advertising. Prior results do not guarantee similar outcomes.

Contact Information:Bragar Eagel & Squire, P.C.Brandon Walker, Esq. Melissa Fortunato, Esq.Marion Passmore, Esq.(212) 355-4648investigations@bespc.comwww.bespc.com

Go here to see the original:
Bragar Eagel & Squire, PC Reminds Investors That Class Action Lawsuits Have Been Filed Against Precigen, Royal Caribbean, Mesoblast, and Loop...

Bone Marrow Stem Cells Comments Off on Bragar Eagel & Squire, PC Reminds Investors That Class Action Lawsuits Have Been Filed Against Precigen, Royal Caribbean, Mesoblast, and Loop… | November 5th, 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.

Go here to see the original:
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.

Read the rest here:
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.

Read Report Overview - https://www.transparencymarketresearch.com/cell-banking-outsourcing-market.html

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.

Request Brochure of Report - https://www.transparencymarketresearch.com/sample/sample.php?flag=B&rep_id=79685

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:

Request for Analysis of COVID-19 Impact on Cell Banking Outsourcing Market- https://www.transparencymarketresearch.com/sample/sample.php?flag=covid19&rep_id=1645

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.

Request for Custom Research - https://www.transparencymarketresearch.com/sample/sample.php?flag=CR&rep_id=1645

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.

Pre Book Cell Banking Outsourcing Market Report - https://www.transparencymarketresearch.com/checkout.php?rep_id=1645&ltype=S

Browse More Trending Reports by Transparency Market Research:

Healthcare Fraud Detection Market: https://www.transparencymarketresearch.com/healthcare-fraud-detection-market.html

Epinephrine Injection Market: https://www.transparencymarketresearch.com/epinephrine-injection-market.html

Dermal Regeneration Matrix Device Market: https://www.transparencymarketresearch.com/dermal-regeneration-matrix-device-market.html

About Us

Transparency Market Research is a next-generation market intelligence provider, offering fact-based solutions to business leaders, consultants, and strategy professionals.

Our reports are single-point solutions for businesses to grow, evolve, and mature. Our real-time data collection methods along with ability to track more than one million high growth niche products are aligned with your aims. The detailed and proprietary statistical models used by our analysts offer insights for making right decision in the shortest span of time. For organizations that require specific but comprehensive information we offer customized solutions through ad hoc reports. These requests are delivered with the perfect combination of right sense of fact-oriented problem solving methodologies and leveraging existing data repositories.

TMR believes that unison of solutions for clients-specific problems with right methodology of research is the key to help enterprises reach right decision.

ContactMr. Rohit BhiseyTransparency Market ResearchState Tower,90 State Street,Suite 700,Albany NY - 12207United StatesUSA - Canada Toll Free: 866-552-3453Email: sales@transparencymarketresearch.comWebsite: https://www.transparencymarketresearch.com/

Read more:
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

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).

Free Sample Report + All Related Graphs & Charts @: https://www.advancemarketanalytics.com/sample-report/69543-global-hematopoietic-stem-cell-transplantation-market-1

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.

Enquire for customization in Report @: https://www.advancemarketanalytics.com/enquiry-before-buy/69543-global-hematopoietic-stem-cell-transplantation-market-1

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.

Get Reasonable Discount on This Premium Report @ https://www.advancemarketanalytics.com/request-discount/69543-global-hematopoietic-stem-cell-transplantation-market-1

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.

Contact US:

Craig Francis (PR & Marketing Manager)

AMA Research & Media LLP

Unit No. 429, Parsonage Road Edison, NJ

New Jersey USA 08837

Phone: +1 (206) 317 1218

[emailprotected]

Read the original:
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 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

Request a discount on the report @ https://www.verifiedmarketresearch.com/ask-for-discount/?rid=24113

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

To read more about the report, visit @ https://www.verifiedmarketresearch.com/product/Stem-Cell-Therapy-Market/

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.

About us:

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.

Contact us:

Mr. Edwyne Fernandes

US: +1 (650)-781-4080UK: +44 (203)-411-9686APAC: +91 (902)-863-5784US Toll-Free: +1 (800)-7821768

Email: [emailprotected]

Go here to see the original:
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

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.

How technologies are transforming high volume injections - essential enablers for patient outcomes

Therapies requiring high volume injections are becoming more common across a broad range of therapeutic areas. This webinar will explore why adherence, safety and quality of life are important for patients, and how these key enablers contribute towards positive outcomes. We will also discuss existing challenges, such as drug development, regulatory, patient accessibility, and how device technologies can further improve patient outcomes. Register Today!

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.

Here is the original post:
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.

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

Bone Marrow Stem Cells Comments Off on BioLineRx Announces Positive Results from Interim Analysis of GENESIS Phase 3 Trial of Motixafortide (BL-8040) in Stem Cell Mobilization – PRNewswire | November 3rd, 2020

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

Read the original:
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.

(Visited 2,622 times, 88 visits today)

Originally posted here:
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

How an Imaging Test Predicts Treatment Response

If youve already gone through a round of treatment for diffuse large B-cell lymphoma and it didnt work, or your cancer came back after treatment, your doctor might start talking to you about having an autologous stem cell transplant. This therapy involves getting high doses of chemotherapy to get rid of your cancer cells, followed by an infusion of stem cells taken from your blood or bone marrow before treatment, to replenish your bodys supply of healthy blood cells.

Related: What is Autologous Stem Cell Transplant?

A stem cell transplant can be a pretty grueling treatment that involves getting very high doses of chemotherapy, spending three to four weeks in the hospital, and enduring side effects like nausea, vomiting, mouth pain, infections, bleeding, and lung inflammation. And after all of that, you still may not get the results you want.

If its going to cure the patient, I think its all worthwhile to go through, Dr. Jakub Svoboda, medical oncologist at Penn Medicine, tells SurvivorNet. If, on the other hand, a stem cell transplant isnt likely to result in a cure, it may not be a good choice for you.

One clue that can help your doctor decide whether a stem cell transplant is worth the risks involved is how well you responded to chemotherapy after your cancer relapsed. People with an aggressive lymphoma that didnt respond well to chemotherapy tend not to have a good outcome from a stem cell transplant.

Having a combination imaging test called a PET/CT scan before a stem cell transplant can help pinpoint your response to chemo, and let you avoid some potentially severe side effects if this treatment isnt likely to cure you. The PET/CT technology has allowed us to select the patients who will likely benefit from autologous STEM cell transplant, Dr. Svoboda says.

The PET/CT scan combines two common cancer imaging tests. PET stands for positron emission tomography. Before the test, you get an injection of a small amount of radioactive sugar, called fluorodeoxyglucose-18 (FGD-18). Because cancer cells use a lot more energy than healthy cells, they absorb the sugar in larger amounts. As the tracer collects in the cancer, it makes those areas light up and become visible, so your doctor can see them on the scan.

CT is short for computed tomography. It takes x-rays of your body from different angles, to create a cross-sectional view of your organs and tissues. The CT scan can reveal areas of your body that are enlarged from the cancer. It alone isnt sensitive enough to pick up metabolically active areas of cancer, which is why the two tests are combined.

A computer combines the PET and CT images to give your doctor a highly detailed, three-dimensional view of your cancer. Having both of these tests together can show your doctor not only whether your cancer is shrinking, but also if its still active.

When people still have some metabolic activity within shrinking areas of cancer, they actually dont do well with the transplant, Dr. Svoboda says.

Its very helpful for doctors to have the information from a PET/CT scan, Dr. Svoboda tells SurvivorNet. You can then offer that patient a different treatment or steer them toward some of the novel therapies.

One alternative to stem cell transplant is chimeric antigen receptor (CAR) T-cell therapy. Its a promising treatment for some people with aggressive non-Hodgkin lymphoma that hasnt responded to other treatments. CAR T-cell therapy involves genetically modifying your own immune cells so that they attack your cancer. CAR T-cell therapy or other treatments actually may have a better chance at working than transplanting in this setting, Dr. Svoboda says.

Learn more about SurvivorNet's rigorous medical review process.

Dr. Jakub Svoboda is a medical oncologist at Penn Medicine, andassociate professor of medicine at the Hospital of the University of Pennsylvania. Read More

Related: What is Autologous Stem Cell Transplant?

If its going to cure the patient, I think its all worthwhile to go through, Dr. Jakub Svoboda, medical oncologist at Penn Medicine, tells SurvivorNet. If, on the other hand, a stem cell transplant isnt likely to result in a cure, it may not be a good choice for you.

One clue that can help your doctor decide whether a stem cell transplant is worth the risks involved is how well you responded to chemotherapy after your cancer relapsed. People with an aggressive lymphoma that didnt respond well to chemotherapy tend not to have a good outcome from a stem cell transplant.

Having a combination imaging test called a PET/CT scan before a stem cell transplant can help pinpoint your response to chemo, and let you avoid some potentially severe side effects if this treatment isnt likely to cure you. The PET/CT technology has allowed us to select the patients who will likely benefit from autologous STEM cell transplant, Dr. Svoboda says.

The PET/CT scan combines two common cancer imaging tests. PET stands for positron emission tomography. Before the test, you get an injection of a small amount of radioactive sugar, called fluorodeoxyglucose-18 (FGD-18). Because cancer cells use a lot more energy than healthy cells, they absorb the sugar in larger amounts. As the tracer collects in the cancer, it makes those areas light up and become visible, so your doctor can see them on the scan.

CT is short for computed tomography. It takes x-rays of your body from different angles, to create a cross-sectional view of your organs and tissues. The CT scan can reveal areas of your body that are enlarged from the cancer. It alone isnt sensitive enough to pick up metabolically active areas of cancer, which is why the two tests are combined.

A computer combines the PET and CT images to give your doctor a highly detailed, three-dimensional view of your cancer. Having both of these tests together can show your doctor not only whether your cancer is shrinking, but also if its still active.

When people still have some metabolic activity within shrinking areas of cancer, they actually dont do well with the transplant, Dr. Svoboda says.

Its very helpful for doctors to have the information from a PET/CT scan, Dr. Svoboda tells SurvivorNet. You can then offer that patient a different treatment or steer them toward some of the novel therapies.

One alternative to stem cell transplant is chimeric antigen receptor (CAR) T-cell therapy. Its a promising treatment for some people with aggressive non-Hodgkin lymphoma that hasnt responded to other treatments. CAR T-cell therapy involves genetically modifying your own immune cells so that they attack your cancer. CAR T-cell therapy or other treatments actually may have a better chance at working than transplanting in this setting, Dr. Svoboda says.

Learn more about SurvivorNet's rigorous medical review process.

Dr. Jakub Svoboda is a medical oncologist at Penn Medicine, andassociate professor of medicine at the Hospital of the University of Pennsylvania. Read More

Read more:
Could an Imaging Test Predict How Well Youll Respond to a Stem Cell Transplant? - SurvivorNet

Bone Marrow Stem Cells Comments Off on Could an Imaging Test Predict How Well Youll Respond to a Stem Cell Transplant? – SurvivorNet | November 1st, 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).

Free Sample Report + All Related Graphs & Charts @: https://www.advancemarketanalytics.com/sample-report/69543-global-hematopoietic-stem-cell-transplantation-market-1

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.

Enquire for customization in Report @: https://www.advancemarketanalytics.com/enquiry-before-buy/69543-global-hematopoietic-stem-cell-transplantation-market-1

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.

Get Reasonable Discount on This Premium Report @ https://www.advancemarketanalytics.com/request-discount/69543-global-hematopoietic-stem-cell-transplantation-market-1

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.

Contact US:

Craig Francis (PR & Marketing Manager)

AMA Research & Media LLP

Unit No. 429, Parsonage Road Edison, NJ

New Jersey USA 08837

Phone: +1 (206) 317 1218

[emailprotected]

Read the original post:
Hematopoietic Stem Cell Transplantation Industry & Technological Innovation: Major Players Hitting the Reset Button - Royal Sutton News

Bone Marrow Stem Cells Comments Off on Hematopoietic Stem Cell Transplantation Industry & Technological Innovation: Major Players Hitting the Reset Button – Royal Sutton News | November 1st, 2020

Is the United States a step closer to approving a form of stem cell transplantation as a treatment for multiple sclerosis? I believe it may be.

Thats because the National Multiple Sclerosis Society (NMSS) has slightly changed its view of autologous hematopoietic stem cell transplantation, or aHSCT.

aHSCT involves removing a patients own stem cells from the blood or bone marrow, using chemotherapy to kill off most of the immune system, and then injecting the stem cells back into the patient. Those stem cells regenerate the immune system, hopefully without any of the rogue immune cells that attack the nervous system and create MS symptoms.

In the past, the National MS Society has failed to make recommendations about how any form of stem cell treatment should be used, at least as far as my research can determine. Now, in an article in JAMA Neurology, a group of neurologists, including members of the NMSS National Medical Advisory Committee, are outlining parts of a stem cell protocol.

The NMSS is now being specific about who might be a candidate for aHSCT:

The National Multiple Sclerosis Society believes that AHSCT may be a useful treatment option for people with relapsing multiple sclerosis who demonstrate substantial breakthrough disease activity (ie, new inflammatory central nervous system lesions and/or clinical relapses) despite treatment with high-efficacy disease-modifying therapy or have contraindications to high-efficacy disease-modifying therapies.

That language seems more aggressive than what the NMSSwrote about an Italian study published earlier this year. In that commentary, the society suggested the procedure might be appropriate for people with secondary progressive MS, and it suggested further study with a larger group:

These results suggest that HSCT might be appropriate in a subgroup of people with SPMS that have significant inflammatory activity as measured by MRI. Further study in larger numbers are needed to understand who among those with secondary progressive MS might benefit from HSCT.

The new guidelines clearly outline which people with relapsing-remitting MS might benefit. They are younger than 50 and have lived with an MS diagnosis for less than 10 years.

The authors recommend that stem cell transplantation be performed in medical centers with substantial experience and expertise. A follow-up regime is proposed, along with the creation of a single database to track people who undergo the procedure. But the article cautions that more research is needed to establish best practices for handling the stem cells and other technical processes.

Some hospitals and clinics in Russia, Mexico, and other locations offer aHSCT to MS patients at a cost of about $50,000. aHSCT also is provided to some MS patients through the U.Ks National Health Service. A list of aHSCT facilities worldwide is available at http://www.hsctstopsms.com.

The authors of the JAMA Neurology article suggest a clinical trial may be the place for someone who wants their MS treated with a stem cell transplant right now. A well-known trial by Dr. Richard Burt shut down about a year ago. However, a trial called BEAT-MS has been enrolling patients at several locations in the U.S. You can find information about other studies at clinicaltrials.gov.

The authors note that joining a trial would assure the patient of quality care with an acceptable protocol and provide the personal satisfaction of knowing they are contributing to answering a very important question for people with MS.

That sounds like a pretty good suggestion to me since the U.S. likely has a long way to go before aHSCT for MS becomes common here, even with the NMSS backing. But its encouraging that finally it is gaining some traction.

Youre invited to follow my personal blog at http://www.themswire.com.

***

Note: Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Multiple Sclerosis News Today or its parent company, BioNews, and are intended to spark discussion about issues pertaining to multiple sclerosis.

Diagnosed with MS at age 32 in 1980, Ed has written the MS Wire column for Multiple Sclerosis News Today since August 2016. He presents timely information on MS, blended with personal experiences. Before retiring from full-time work in 2012, Tobias spent more than four decades in broadcast and on-line newsrooms as a manager, reporter, and radio news anchor. Hes won several national broadcast awards. As an MS patient communicator, Ed consults with healthcare and social media companies. Hes the author of Were Not Drunk, We Have MS: A tool kit for people living with multiple sclerosis. Ed and his wife split time between the Washington, D.C. suburbs and Floridas Gulf Coast.

Read the original here:
aHSCT Gets a Boost in US With NMSS Recommendations - Multiple Sclerosis News Today

Bone Marrow Stem Cells Comments Off on aHSCT Gets a Boost in US With NMSS Recommendations – Multiple Sclerosis News Today | October 31st, 2020

DetailsCategory: Small MoleculesPublished on Friday, 30 October 2020 17:39Hits: 249

- Enrollment to cease immediately; topline data anticipated in H1 2021-

TEL AVIV, Israel I October 30, 2020 I 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

SOURCE: BioLineRx

Link:
BioLineRx Announces Positive Results from Interim Analysis of GENESIS Phase 3 Trial of Motixafortide (BL-8040) in Stem Cell Mobilization | Small...

Bone Marrow Stem Cells Comments Off on BioLineRx Announces Positive Results from Interim Analysis of GENESIS Phase 3 Trial of Motixafortide (BL-8040) in Stem Cell Mobilization | Small… | October 31st, 2020

The latest Stem Cell Banking market research report offers a top to bottom analysis of this business sphere in terms of potential industry size, supply chain, growth dynamics, opportunity analysis, and competitive landscape. Furthermore, it extends through abstracts on various industry segments, inclusive of a rundown of the business scenario across the various regional markets. Additionally, the study provide insights into to the impact of Covid-19 pandemic and recommends strategies that could maximize ROI amid these uncertain times.

Key areas covered in the Covid-19 impact assessment:

An overview of the regional analysis:

Request Sample Copy of this Report @ https://www.aeresearch.net/request-sample/341604

Other important inclusions in the Stem Cell Banking market report:

Key Questions Answered in The Report:

What will the Stem Cell Banking market growth rate?

What are the key factors driving the global Stem Cell Banking market?

Who are the key manufacturers in Stem Cell Banking market space?

What are the market opportunities and overview of the Stem Cell Banking market?

What are sales, revenue, and price analysis of top manufacturers of Stem Cell Banking market?

What are the Stem Cell Banking market opportunities and threats faced by the vendors in the global Stem Cell Banking Industry?

What are sales, revenue, and price analysis by types and applications of Stem Cell Banking Industry?

Request Customization on This Report @ https://www.aeresearch.net/request-for-customization/341604

Go here to read the rest:
Stem Cell Banking Market to witness an impressive growth during the forecast pe - News by aeresearch

Bone Marrow Stem Cells Comments Off on Stem Cell Banking Market to witness an impressive growth during the forecast pe – News by aeresearch | October 31st, 2020

The Global Hematopoietic Stem Cell Transplantation (HSCT) Market report offers key insights into the worldwide Hematopoietic Stem Cell Transplantation (HSCT) market. It presents a holistic overview of the market, with an in-depth summary of the markets leading players. The report is inclusive of indispensable information related to the leading competitors in this business sector and carefully analyzes the micro- and macro-economic market trends. The latest report specializes in studying primary and secondary market drivers, market share, the leading market segments, and comprehensive geographical analysis. Vital information about the key market players and their key business strategies, such as mergers & acquisitions, collaborations, technological innovation, and trending business policies, is one of the key components of the report.

Get a sample of the report @ https://www.reportsanddata.com/sample-enquiry-form/3627

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:

China Cord Blood Corp, Pluristem Therapeutics Inc., CBR Systems Inc CellGenix Technologie Transfer GmbH, Cryo-Save AG Kite Pharma Inc., Regen Biopharma Inc., ViaCord Inc., BiolineRx, Cynata Therapeutics, Cesca Therapeutics Inc, Lonza Group Ltd, TiGenix N.V., Bluebird Bio, Cellular Dynamics International, and Escape Therapeutics Inc., among others.

Furthermore, our market analysts have drawn focus to the significant impact of the COVID-19 pandemic on the global Hematopoietic Stem Cell Transplantation (HSCT) market and its key segments and sub-segments. The grave aftereffects of the pandemic on the global economy, and subsequently, on this particular business sphere, have been enumerated in this section of the report. The report considers the key market-influencing parameters, delivering a detailed future impact assessment. The Hematopoietic Stem Cell Transplantation (HSCT) market has been devastated by the pandemic, which has culminated in drastic changes to the market dynamics and demand trends.

In market segmentation by types of Hematopoietic Stem Cell Transplantation (HSCT), the report covers-

In market segmentation by applications of the Hematopoietic Stem Cell Transplantation (HSCT), the report covers the following uses-

Request a discount on the report @ https://www.reportsanddata.com/discount-enquiry-form/3627

Moreover, the research report thoroughly examines the size, share, and market volume of the Hematopoietic Stem Cell Transplantation (HSCT) industry in the historical years to forecast the same valuations over the forecast duration. It offers exhaustive SWOT analysis, Porters Five Forces analysis, feasibility analysis, and investment return analysis of the Hematopoietic Stem Cell Transplantation (HSCT) market, assessed using certain effective analytical tools. The report also provides strategic recommendations to market entrants to help them navigate around the entry-level barriers.

The global Hematopoietic Stem Cell Transplantation (HSCT) market is geographically categorized into:

The following timeline is considered for market estimation:

Historical Years: 2017-2018

Base Year: 2019

Estimated Year: 2020

Forecast Years: 2020-2027

Key Coverage of the Report:

To read more about the report, visit@ https://www.reportsanddata.com/report-detail/hematopoietic-stem-cell-transplantation-hsct-market

Thank you for reading our report. For further information or queries regarding the report, please get in touch with us. Our team will make sure your report is tailored according to your requirements.

About Us:

Our in-house experts assist our clients with advice based on their proficiency in the market that helps them in creating a compendious database for the clients. Our team offers expert insights to clients to guide them through their business ventures. We put in rigorous efforts to keep our clientele satisfied and focus on fulfilling their demands to make sure that the end-product is what they desire. We excel in diverse fields of the market and with our services extending to competitive analysis, research and development analysis, and demand estimation among others, we can help you invest your funds in the most beneficial areas for research and development. You can rely on us to provide every significant detail you might need in your efforts to make your business flourish.

Contact Us:

John Watson

Head of Business Development

Reports and Data|Web: http://www.reportsanddata.com

Direct Line:+1-212-710-1370

E-mail: [emailprotected]

Read more from the original source:
How Hematopoietic Stem Cell Transplantation (HSCT) Market Will Dominate In Coming Years? Report Covering Products, Financial Information,...

Bone Marrow Stem Cells Comments Off on How Hematopoietic Stem Cell Transplantation (HSCT) Market Will Dominate In Coming Years? Report Covering Products, Financial Information,… | October 30th, 2020