Monthly Archives: August 2021

A study released inSTEM CELLS Translational Medicinehas confirmed the safety of a novel type of cellular therapy for knee pain caused by osteoarthritis. Conducted by a multi-institutional team of researchers in Japan who had developed the new therapy, the study was designed to confirm that their treatment which involves transplanting the patients own mesenchymal stem cells (MSCs) into the affected knee did not cause tumors.

The results showed that five years after transplantation, osteoarthritis-related tears to the knee meniscus had healed and, just as importantly, none of the patients experienced any serious side effects from the treatment. The meniscus is a crescent-shaped cartilage in the knee joint that plays a role in shock absorption. Age-related damage to the meniscus often leads to the progression of osteoarthritis of the knee.

Chronic knee pain is a major issue for the aging, affecting approximately 25 percent of all adults, according to the Centers for Disease Control and Prevention (CDC). Osteoarthritis is the most common cause of this condition in people aged 50 and older. Along with pain, which can be debilitating, knee problems can significantly affect the persons mobility and quality of life.

Knee replacement surgery is the gold standard of treatment, with the majority of people experiencing a dramatic reduction in pain and, thus, improvement in their ability to live a normal life. However, though rare, such surgery does come with risks such as the possibility of infection.

Lead investigator Mitsuru Mizuno, DVM, Ph.D. and corresponding author Ichiro Sekiya, M.D., Ph.D. Credit: AlphaMed Press

Cellular therapies are showing great potential as a less invasive way to treat difficult-to-heal knee injuries. The team behind the current study, which included researchers from Tokyo Medical and Dental University, Kyoto University and Kazusa DNA Research Institute, recently developed a therapy involving the transplantation of MSCs derived from the knees soft tissue (the synovium) into the injured meniscus. MSCs are multipotent adult stem cells present in the umbilical cord, bone marrow, fat, dental and other body tissues. Their ability to secrete biologically active molecules that exert beneficial effects on injured tissues makes them a promising target in regenerative medicine.

But some stem cell treatments have been known to cause tumors, which is why the team wanted to ensure that their therapy was free of any negative side effects. In particular, they wanted to investigate the safety of any MSCs that might show a type of chromosomal disorder called trisomy 7.

Trisomy 7 occurs frequently in patients with severe knee disease such as osteoarthritis. The detection of trisomy 7 in epithelial cells has been associated with tumor formation. However, the safety of these cells after transplantation has not been investigated. Thats what we wanted to learn from this study, said corresponding author Ichiro Sekiya, M.D., Ph. D., director and professor of the Center for Stem Cell and Regenerative Medicine (CSCRM) at Tokyo Medical and Dental University.

Mitsuru Mizuno, DVM, Ph.D., assistant professor with CSCRM, served as the studys lead investigator. He reported on the results. We recruited 10 patients for the study and transplanted their own stem cells into the affected knee joints, then followed up with MRIs over the next five years. The images revealed that tears in the patients knee meniscus were obscured three years after transplantation. We also identified trisomy 7 in three of the patients, yet no serious adverse events including tumor formation were observed in any of them.

Dr. Sekiya added, Keep in mind that these were autologous MSCs used in our study, which means that the transplanted MSCs came from the patients themselves. Any problems that might arise in the case of allogeneic cells, which are donated by someone other than the patient, still need to be determined.

Nevertheless, we believe that these data suggest that MSCs with trisomy 7 are safe for transplantation into human knees and show much promise in treating osteoarthritis.

This study highlights the ability of a patients own stem cells to potentially heal torn cartilage in the knee, said Anthony Atala, M.D., Editor-in-Chief ofSTEM CELLS Translational Medicineand director of the Wake Forest Institute for Regenerative Medicine. These outcomes suggest a potential approach that could change the overall physical health of patients who suffer from osteoarthritis and experience debilitating joint pain. We look forward to the continuation of this research to further document clinical efficacy.

Reference: Transplantation of human autologous synovial mesenchymal stem cells with trisomy 7 into the knee joint and 5 years of follow-up by Mitsuru Mizuno, Kentaro Endo, Hisako Katano, Naoki Amano, Masaki Nomura, Yoshinori Hasegawa, Nobutake Ozeki, Hideyuki Koga, Naoko Takasu, Osamu Ohara, Tomohiro Morio and Ichiro Sekiya, 3 August 2021, STEM CELLS Translational Medicine.DOI: 10.1002/sctm.20-0491

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Safety of Stem Cell Therapy for Chronic Knee Pain Confirmed in New Study - SciTechDaily

DUBLIN, Aug. 4, 2021 /PRNewswire/ -- The "Asia Pacific Cell Therapy Market Size, Share & Trends Analysis Report by Use-type (Clinical-use, Research-use), by Therapy Type (Autologous, Allogeneic) and Segment Forecasts, 2021-2028" report has been added to ResearchAndMarkets.com's offering.

The Asia Pacific cell therapy market size is expected to reach USD 2.9 billion by 2028. The market is expected to expand at a CAGR of 14.9% from 2021 to 2028.

Rapid advancements in regenerative medicine are anticipated to provide effective solutions for chronic conditions. A substantial number of companies in the growing markets, such as India and South Korea, are striving to capitalize on the untapped opportunities in the market, thereby driving the market.

The growth is greatly benefitted by the fund and regulatory support from government bodies and regulatory agencies. For instance, in August 2020, the government of South Korea passed an Act on the Safety and Support of Advanced Regenerative Medical Treatment and Medicine to establish a regulatory system for patient safety during quality control and clinical trials and to strengthen the regulatory support for regenerative medicine development.

The implementation of the act is expected to enhance clinical studies and approvals of regenerative medicine in South Korea. Furthermore, CAR-T and TCR T-cell therapies have already revolutionized hematologic cancer treatment. With the onset of the COVID-19 pandemic, scientists are deciphering its potential against the novel coronavirus. The concept of using T cells against chronic viral infections, such as HIV and hepatitis B, has already been proposed.

Based on the previous research insights, Singapore-based Duke-NUS medical school's emerging infectious diseases research program demonstrated the utility of these immunotherapies in treating patients with COVID-19 infection.

Thus, an increase in research for use of cell therapies for COVID-19 treatment is expected to drive the market in Asian countries. In April 2021, a team of researchers from Japan used induced pluripotent stem cells (iPS) to find drugs that can effectively inhibit the coronavirus and other RNA viruses.

Key Topics Covered:

Chapter 1 Methodology and Scope

Chapter 2 Executive Summary2.1 Market Snapshot

Chapter 3 Cell Therapy Market Variables, Trends, and Scope3.1 Market Trends and Outlook3.2 Market Segmentation and Scope3.3 Market Dynamics3.3.1 Market driver analysis3.3.1.1 Rise in number of clinical studies for cellular therapies in Asia Pacific3.3.1.2 Expanding regenerative medicine landscape in Asian countries3.3.1.3 Introduction of novel platforms and technologies3.3.2 Market restraint analysis3.3.2.1 Ethical concerns3.3.2.2 Clinical issues pertaining to development & implementation of cell therapy3.3.2.2.1 Manufacturing issues3.3.2.2.2 Genetic instability3.3.2.2.3 Condition of stem cell culture3.3.2.2.4 Stem cell distribution after transplant3.3.2.2.5 Immunological rejection3.3.2.2.6 Challenges associated with allogeneic mode of transplantation3.3.3 Market opportunity analysis3.3.3.1 Approval of Kymriah and Yescarta across various Asian countries3.3.3.2 Developments in CAR T-cell therapy for solid tumors3.3.4 Market challenge analysis3.3.4.1 Operational challenges associated with cell therapy development & usage3.3.4.1.1 Volume of clinical trials for cell and gene therapy vs accessible qualified centers3.3.4.1.2 Complex patient referral pathway3.3.4.1.3 Patient treatment, selection, and evaluation3.3.4.1.4 Availability of staff vs volume of cell therapy treatments3.4 Penetration and Growth Prospect Mapping for Therapy Type, 20203.5 Business Environment Analysis3.5.1 SWOT Analysis; By factor (Political & Legal, Economic and Technological)3.5.2 Porter's Five Forces Analysis3.6 Regulatory Framework3.6.1 China3.6.1.1 Regulatory challenges & risk of selling unapproved cell therapies3.6.2 Japan

Chapter 4 Cell Therapy Market: COVID-19 Impact analysis4.1 Challenge's analysis4.1.1 Manufacturing & supply challenges4.1.2 Troubleshooting the manufacturing & supply challenges associated to COVID-194.2 Opportunities analysis4.2.1 Need for development of new therapies against SARS-CoV-24.2.1.1 Role of T-cell based therapeutics in COVID-19 management4.2.1.2 Role of mesenchymal cell-based therapeutics in COVID-19 management4.2.2 Rise in demand for supply chain management solutions4.3 Challenges in manufacturing cell therapies against COVID-194.4 Clinical Trial Analysis4.5 Key Market Initiatives

Chapter 5 Asia Pacific Cell Therapy CDMOs/CMOs Landscape5.1 Role of Cell Therapy CDMOs5.2 Key Trends Impacting Asia Cell Therapy CDMO Market5.2.1 Regulatory reforms5.2.2 Expansion strategies5.2.3 Rising investments5.3 Manufacturing Volume Analysis5.3.1 Wuxi Biologics5.3.2 Samsung Biologics5.3.3 GenScript5.3.4 Boehringer Ingelheim5.3.5 Seneca Biopharma, Inc.5.3.6 Wuxi AppTech5.4 Competitive Milieu5.4.1 Regional network map for major players

Chapter 6 Asia Pacific Cell Therapy Market: Use Type Business Analysis6.1 Market (Stem & non-stem cells): Use type movement analysis6.2 Clinical Use6.2.1 Market (stem & non-stem cells) for clinical use, 2017 - 2028 (USD Million)6.2.2 Market (stem & non-stem cells) for clinical use, by therapeutic area6.2.2.1 Malignancies6.2.2.1.1 Market (stem & non-stem cells) for malignancies, 2017 - 2028 (USD Million)6.2.2.2 Musculoskeletal disorders6.2.2.3 Autoimmune disorders6.2.2.4 Dermatology6.2.3 Market (stem & non-stem cells) for clinical use, by cell type6.2.3.1 Stem cell therapies6.2.3.1.1 Market, 2017 - 2028 (USD Million)6.2.3.1.2 BM, blood, & umbilical cord-derived stem cells/mesenchymal stem cells6.2.3.1.3 Adipose-derived stem cell therapies6.2.3.1.4 Other stem cell therapies6.2.3.2 Non-stem cell therapies6.3 Research Use

Chapter 7 Asia Pacific Cell Therapy Market: Therapy Type Business Analysis7.1 Market (Stem & Non-stem Cells): Therapy type movement analysis7.2 Allogeneic Therapies7.3 Autologous Therapies

Chapter 8 Asia Pacific Cell Therapy Market: Country Business Analysis8.1 Market (Stem & Non-stem Cells) Share by Country, 2020 & 2028

Chapter 9 Asia Pacific Cell Therapy Market: Competitive Landscape

For more information about this report visit https://www.researchandmarkets.com/r/3hdt1c

Media Contact: Research and Markets Laura Wood, Senior Manager [emailprotected]

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Asia-Pacific Cell Therapy Market 2021-2028 - Opportunities in the Approval of Kymriah and Yescarta - PRNewswire

Myelodysplastic syndrome (MDS) refers to a group of bone marrow disorders that interfere with the healthy production of blood cells. Its a type of blood cancer.

Treatments for MDS can range from long-term medication to stem cell transplants. Your options depend on the type of MDS you have and how serious it is. You might also consider your age and overall health when choosing a treatment plan.

Various treatments can slow disease progression, relieve symptoms, and prevent complications. You can also try certain lifestyle changes and natural remedies that may help relieve your symptoms and improve your quality of life.

Your bone marrow produces immature blood cells, also called stem cells. These then develop into one of three types of mature blood cells:

If you have MDS, not all of these stem cells mature. As a result, immature cells can remain in the bone marrow or die. You will have lower levels of mature blood cells in your bloodstream.

A reduced mature blood cell count is a condition known as cytopenia, and its a main characteristic of MDS. A blood test known as a complete blood count (CBC) is one of the first diagnostic tests your doctor will order if they suspect you have MDS.

Removing bone marrow samples through aspiration and biopsy can also help your doctor better understand the nature of your blood marrow disorder. Once your doctor has diagnosed and treated your MDS, these tests can also show how well your bone marrow is responding to treatment.

You will often have a healthcare team if you have this type of disorder, which may include:

The team will develop a treatment plan thats partially based on the type of MDS you have. The World Health Organization (WHO) identifies six main types of MDS.

Your treatment plan may also be based on the prognostic score (outlook for survival) of the disease. MDS is different from most forms of cancer, which are grouped in stages and grades, because its scored on several factors, including:

Before you start MDS treatment, you might also consider your:

Next, well discuss each of the main treatment options for this group of diseases.

Supportive therapy is meant to treat MDS symptoms and prevent complications, rather than treat the underlying disorder itself. Supportive therapy is often used alongside other treatments.

Examples of supportive therapy include:

Lenalidomide is a type of medication called an immunomodulatory agent. Your doctor may suggest this oral medication if you have MDS and a certain genetic change known as an isolated del(5q) chromosome abnormality.

Lenalidomide helps boost red blood cell production in your bone marrow. Its designed to reduce your dependence on blood transfusions.

Experts in a 2017 research review called it an excellent option for MDS patients with low or intermediate disease risk. Potential side effects include:

Antithymocyte globulin is in a large group of drugs known as immunosuppressants that weaken the bodys immune response. Organ transplant recipients usually take them to help prevent rejection of the new organ. You may take antithymocyte globulin to keep your immune system from attacking stem cells in your bone marrow.

Immunosuppressant therapy may be appropriate for you if you have lower-risk MDS and havent had effective results with ESAs and transfusions. You might also try it if you have one or more autoimmune diseases.

One 2018 study found that antithymocyte globulin was effective in about 50 percent of the MDS cases studied.

Certain chemotherapy drugs, known as hypomethylating agents, activate specific genes in your stem cells to help them mature. Two examples of these agents are azacitidine and decitabine. These drugs are used when your doctor determines there is a serious risk for leukemia, which is a serious potential complication of MDS.

Chemotherapy can help improve blood cell counts, sometimes to the point where you no longer need transfusions, and reduce your risk of leukemia. Potential side effects include:

Other chemotherapy drugs may be given with the goal of killing atypical stem cells and allowing more of your healthy cells to mature.

While high-dose chemotherapy drugs can be very effective at sending MDS into remission, the side effects can be severe. You could experience a serious drop in white blood cells, and later, a greater risk of infections developing and progressing quickly.

A stem cell transplant involves removing some of your bone marrow, usually from the pelvic bone, and replacing it with bone marrow that produces healthy blood cells.

The procedure is usually reserved for more serious cases of MDS. Stem cell transplant is the closest treatment option to a cure, but its an invasive and challenging therapy. Because of this, stem cell transplant is limited to people who are considered healthy enough for both the procedure and the recovery process.

Doctors often use chemotherapy drugs with stem cell transplant to treat MDS. Together, they help support the growth of healthy blood cells to replace unhealthy or atypical cells.

While transplants are often very effective at achieving disease remission, particularly in certain patients, the Aplastic Anemia and MDS International Foundation says that a majority of MDS patients will see their condition return over time.

In addition to traditional medications and procedures to treat MDS, complementary or alternative medicine (CAM) may also help provide you with symptom relief. While these therapies may not affect blood cell production, they may help you cope with symptoms such as anxiety and stress that can come with a chronic disease such as MDS.

Consider some of these treatments and remedies after first discussing them with a healthcare professional:

MDS can affect anyone at any age but generally affects adults ages 70 and older. According to the American Cancer Society (ACS), about 10,000 people are diagnosed with MDS in the United States per year.

Disease outcomes vary considerably. Its difficult to predict someones outcome because people respond differently to treatment.

ACS survival statistics range from a median survival of 8.8 years for people with a very low risk score to less than 1 year for MDS patients with a very high risk score.

These survival rates are based on data that includes years before treatments like chemotherapy were available. Its important to remember that researchers are continuing to develop new treatments that may improve disease outcomes.

You may have no symptoms early on or if you have mild MDS. However, for most people with the disease, anemia (low red blood cell counts) and symptoms such as chronic fatigue and shortness of breath are common.

If you have low white blood cell counts, the risk of serious infection may always be present. Low platelet counts can lead to easy bruising and bleeding complications.

MDS is a type of blood cancer in which your bone marrow doesnt produce high enough levels of mature red blood cells, white blood cells, or platelets.

A variety of treatments are available to manage MDS, including blood transfusions, immunosuppressant drugs, chemotherapy, and stem cell transplants. Each treatment comes with its own risks, but your doctor or cancer treatment team will help guide you toward an approach that may work best for you.

Read more from the original source:
Myelodysplastic Syndrome Treatment Options - Healthline

DetailsCategory: DNA RNA and CellsPublished on Tuesday, 03 August 2021 10:03Hits: 758

Off-the-Shelf CAR T-cell Product Candidate Derived from Clonal Master iPSC Line with Novel CD19-specific 1XX CAR Integrated into TRAC Locus

Phase 1 Clinical Study will Evaluate Three Dosing Regimens of FT819 for Patients with Advanced B-cell Leukemias and Lymphomas

SAN DIEGO, CA, USA I August 02, 2021 I Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, announced today that the first patient has been treated with FT819, an off-the-shelf chimeric antigen receptor (CAR) T-cell therapy targeting CD19+ malignancies. FT819 is the first-ever CAR T-cell therapy derived from a clonal master induced pluripotent stem cell (iPSC) line, a renewable cell source that enables mass production of high quality, allogeneic CAR T cells with greater product consistency, off-the-shelf availability, and broader patient accessibility. FT819 is engineered with several first-of-kind features designed to improve the safety and efficacy of CAR T-cell therapy.

Remarkable clinical outcomes have been achieved through treatment with patient-derived CAR T-cell therapy, however, next-generation approaches are necessary to reach more patients who are in need of these highly-effective therapies, said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. Treatment of the first-ever patient with FT819 ushers in a new era for off-the-shelf CAR T-cell therapy, with the potential to overcome the real-world limitations of existing patient- and donor-derived therapeutic approaches and unlock the full potential of CAR T-cell therapy. We would like to thank our collaborators at Memorial Sloan Kettering Cancer Center, whose partnership over the past five years has profoundly contributed to this landmark achievement.

FT819 was designed to specifically address several limitations associated with the current generation of patient- and donor-derived CAR T-cell therapies. Under a collaboration with Memorial Sloan Kettering Cancer Center (MSK) led by Michel Sadelain, M.D., Ph.D., Director, Center for Cell Engineering and Head, Gene Expression and Gene Transfer Laboratory, the Company incorporated several first-of-kind features into FT819 including:

The multi-center Phase 1 clinical trial of FT819 is designed to determine the recommended Phase 2 dose and schedule of FT819 and assess its safety and clinical activity in adult patients with relapsed/refractory acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), and B-cell lymphomas (BCL). Three treatment regimens will be independently evaluated for each type of malignancy in dose escalation: Regimen A as a single dose of FT819; Regimen B as a single dose of FT819 with IL-2 cytokine support; and Regimen C as three fractionated doses of FT819. For each indication and regimen, dose-expansion cohorts may be enrolled to further evaluate the clinical activity of FT819. The first patient with relapsed / refractory ALL was enrolled in Regimen A and received a dose of 90 million cells.

At the 24th American Society of Gene & Cell Therapy Annual Meeting held in May 2021, the Company presented preclinical data demonstrating that FT819 exhibits uniform 1XX CAR expression with complete elimination of endogenous TCR expression. The product candidate was shown to contain a stem- and central-memory T-cell phenotype, and had high-level expression of the activation marker CD25 and the trafficking marker CXCR4 and very low-level expression of the checkpoint proteins PD1, TIM3, CTLA4 and LAG3. Additionally, data from functional assessments showed that FT819 had potent antigen-specific cytolytic activity in vitro against CD19-expressing leukemia and lymphoma cell lines comparable to that of healthy donor-derived CAR T cells, and persisted and maintained tumor clearance in the bone marrow in an in vivo disseminated xenograft model of lymphoblastic leukemia.

Pursuant to a license agreement with MSK, Fate Therapeutics has an exclusive license for all human therapeutic use to U.S. Patent No. 10,370,452, which covers compositions and uses of effector T cells expressing a CAR, where such T cells are derived from a pluripotent stem cell including an iPSC. In addition to the patent rights licensed from MSK, the Company owns an extensive intellectual property portfolio that broadly covers compositions and methods for the genome editing of iPSCs using CRISPR and other nucleases, including the use of CRISPR to insert a CAR in the TRAC locus for endogenous transcriptional control.

Fate Therapeutics haslicensedintellectual propertyfrom MSK on which Dr. Sadelain is aninventor.As a result of the licensing arrangement, MSK has financial interests related to Fate Therapeutics.

About Fate Therapeutics iPSC Product PlatformThe Companys proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that are designed to be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Companys first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Companys platform is uniquely designed to overcome numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics iPSC product platform is supported by an intellectual property portfolio of over 350 issued patents and 150 pending patent applications.

About FT819FT819 is an investigational, universal, off-the-shelf, T-cell receptor (TCR)-less CD19 chimeric antigen receptor (CAR) T-cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line, which is engineered with the following features designed to improve the safety and efficacy of CAR19 T-cell therapy: a novel 1XX CAR signaling domain, which has been shown to extend T-cell effector function without eliciting exhaustion; integration of the CAR19 transgene directly into the T-cell receptor alpha constant (TRAC) locus, which has been shown to promote uniform CAR19 expression and enhanced T-cell potency; and complete bi-allelic disruption of TCR expression for the prevention of graft-versus-host disease (GvHD). FT819 demonstrated antigen-specific cytolytic activity in vitro against CD19-expressing leukemia and lymphoma cell lines comparable to that of primary CAR T cells, and persisted and maintained tumor clearance in the bone marrow in an in vivo disseminated xenograft model of lymphoblastic leukemia (Valamehr et al. 2020). FT819 is being investigated in a multi-center Phase 1 clinical trial for the treatment of relapsed / refractory B-cell malignancies, including B-cell lymphoma, chronic lymphocytic leukemia, and acute lymphoblastic leukemia (NCT04629729).

About Fate Therapeutics, Inc.Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Companys immuno-oncology pipeline includes off-the-shelf, iPSC-derived natural killer (NK) cell and T-cell product candidates, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens using chimeric antigen receptors (CARs). Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit http://www.fatetherapeutics.com.

SOURCE: Fate Therapeutics

Excerpt from:
Fate Therapeutics Announces Treatment of First Patient in Landmark Phase 1 Clinical Trial of FT819, the First-ever iPSC-derived CAR T-Cell Therapy |...

Colin Ray Jackson, CBE, 54, is a Welsh former sprinter and hurdling Olympic silver medal champion. Colins world record for his 60 metres hurdles stood for an incredible 27 years. As with most athletes of his calibre, Colin suffers with ongoing injuries from his sports days and will be undergoing a treatment to reduce the pain which Mike Tyson recently underwent too.

In recent years, stem cell therapy has been hailed as a miracle cure for many conditions, from wrinkles to spinal repair.

A stem cell is an immature, basic cell that has not yet developed to become, say, a skin cell or a muscle cell or a nerve cell.

There are different types of stem cells that the body can use for different purposes.

There is evidence that stem cell treatments work by triggering damaged tissues in the body to repair themselves, often referred to as regenerative therapy.

In animal studies, stem cell treatments have shown promise for various diseases, including heart disease, Parkinsons disease and muscular dystrophy.

A study undertaken by Dr Timothy McGuine found that 34 percent of athletes involved in the one-year study were more likely to report a history of knee and hip injuries.

Additionally, he found that specialised athletes, such as those competing in the Olympic games, were twice as likely to sustain a gradual onset or repetitive use injuries than athletes who did not specialise.

Dr McGuine also found that these athletes who find themselves competing year-round, stressing the same muscles and movements, and predisposed to the symptoms of burnout are at higher risk of long-term injuries.

Many doctors and athletes use stem cell therapy to treat sports injuries, such as Achilles tendinopathy or damaged knee ligaments, said Sports Health.

The site continued: While increasing in popularity, stem cell therapy is not considered standard practice by sports medicine doctors and not covered by most insurance companies.

The process of collecting stem cells is often called harvesting. Physicians usually harvest stem cells from the patients fat, blood, or bone marrow.

Many physicians who use stem cell therapy hypothesize that, when placed into a certain environment, stem cells can transform to meet a certain need.

Other sports stars who underwent stem cell therapy for long-term injuries included Cristiano Ronaldo, Rafael Nadal and most recently Mike Tyson.

Continued here:
Colin Jackson health: Im in constant pain Athlete to undergo stem cell therapy to help - Express

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First Patient Treated for Relapsed / Refractory ALL in Landmark Phase 1 Clinical Trial of FT819, the First-ever iPSC-derived CAR T-cell Therapy; Off-the-Shelf Product Candidate Derived from Clonal Master iPSC Line with Novel CD19-specific 1XX CAR Integrated into TRAC Locus

FT516 Interim Phase 1 Data for Relapsed / Refractory Lymphoma Featured at ASCO; 8 of 11 Patients in Dose Cohorts 2 and 3 Achieved Objective Response, including 6 Patients with Complete Response

Interim Phase 1 Data from FT516 and FT538 Programs for Relapsed / Refractory AML Highlighted at May Investor Event; 5 of 12 Patients Achieved Objective Response with Complete Clearance of Bone Marrow Leukemic Blasts

New Phase 1 Clinical Data from FT516 and FT596 Programs in Relapsed / Refractory Lymphoma to be Featured at Investor Event on August 19

SAN DIEGO, Aug. 04, 2021 (GLOBE NEWSWIRE) -- Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, today reported business highlights and financial results for the second quarter ended June 30, 2021.

We are very pleased with the early clinical safety and activity we have observed with our off-the-shelf, iPSC-derived NK cell programs in relapsed / refractory lymphoma and acute myeloid leukemia, where interim Phase 1 data indicate FT516 and FT538 are well tolerated and can deliver complete responses for patients. We look forward to sharing additional clinical data from our FT516 and FT596 programs in B-cell lymphoma at our upcoming investor event, said Scott Wolchko, President and Chief Executive Officer of Fate Therapeutics. Additionally, treatment of the first patient with FT819, the first-ever iPSC-derived T-cell therapy to undergo clinical investigation, is a landmark achievement and further demonstrates the Companys leadership in off-the-shelf, iPSC-derived cell therapy and the versatility of its proprietary iPSC Product Platform.

B-cell Malignancy Disease Franchise

AML Disease Franchise

Multiple Myeloma Franchise

Solid Tumor Franchise

Other Corporate Highlights

Second Quarter 2021 Financial Results

Today's Conference Call and WebcastThe Company will conduct a conference call today, Wednesday, August 4, 2021 at 5:00 p.m. ET to review financial and operating results for the quarter ended June 30, 2021. In order to participate in the conference call, please dial please dial 800-773-2954 (toll free) or 847-413-3731 (toll) and refer to conference ID 50196101. The live webcast can be accessed under "Events & Presentations" in the Investors section of the Company's website at http://www.fatetherapeutics.com. The archived webcast will be available on the Company's website beginning approximately two hours after the event.

About Fate Therapeutics iPSC Product PlatformThe Companys proprietary induced pluripotent stem cell (iPSC) product platform enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with other cancer treatments. Human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body. The Companys first-of-kind approach involves engineering human iPSCs in a one-time genetic modification event and selecting a single engineered iPSC for maintenance as a clonal master iPSC line. Analogous to master cell lines used to manufacture biopharmaceutical drug products such as monoclonal antibodies, clonal master iPSC lines are a renewable source for manufacturing cell therapy products which are well-defined and uniform in composition, can be mass produced at significant scale in a cost-effective manner, and can be delivered off-the-shelf for patient treatment. As a result, the Companys platform is uniquely capable of overcoming numerous limitations associated with the production of cell therapies using patient- or donor-sourced cells, which is logistically complex and expensive and is subject to batch-to-batch and cell-to-cell variability that can affect clinical safety and efficacy. Fate Therapeutics iPSC product platform is supported by an intellectual property portfolio of over 350 issued patents and 150 pending patent applications.

About FT516FT516 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered to express a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor, which has been modified to prevent its down-regulation and to enhance its binding to tumor-targeting antibodies. CD16 mediates antibody-dependent cellular cytotoxicity (ADCC), a potent anti-tumor mechanism by which NK cells recognize, bind and kill antibody-coated cancer cells. ADCC is dependent on NK cells maintaining stable and effective expression of CD16, which has been shown to undergo considerable down-regulation in cancer patients. In addition, CD16 occurs in two variants, 158V or 158F, that elicit high or low binding affinity, respectively, to the Fc domain of IgG1 antibodies. Numerous clinical studies with FDA-approved tumor-targeting antibodies, including rituximab, trastuzumab and cetuximab, have demonstrated that patients homozygous for the 158V variant, which is present in only about 15% of patients, have improved clinical outcomes. FT516 is being investigated in a multi-dose Phase 1 clinical trial as a monotherapy for the treatment of acute myeloid leukemia and in combination with CD20-targeted monoclonal antibodies for the treatment of advanced B-cell lymphoma (NCT04023071). Additionally, FT516 is being investigated in a multi-dose Phase 1 clinical trial in combination with avelumab for the treatment of advanced solid tumor resistant to anti-PDL1 checkpoint inhibitor therapy (NCT04551885).

About FT596FT596 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with three anti-tumor functional modalities: a proprietary chimeric antigen receptor (CAR) optimized for NK cell biology that targets B-cell antigen CD19; a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor, which has been modified to prevent its down-regulation and to enhance its binding to tumor-targeting antibodies; and an IL-15 receptor fusion (IL-15RF) that augments NK cell activity. In preclinical studies of FT596, the Company has demonstrated that dual activation of the CAR19 and hnCD16 targeting receptors enhances cytotoxic activity, indicating that multi-antigen engagement may elicit a deeper and more durable response. Additionally, in a humanized mouse model of lymphoma, FT596 in combination with the anti-CD20 monoclonal antibody rituximab showed enhanced killing of tumor cells in vivo as compared to rituximab alone. FT596 is being investigated in a multi-center Phase 1 clinical trial for the treatment of relapsed / refractory B-cell lymphoma as a monotherapy and in combination with rituximab, and for the treatment of relapsed / refractory chronic lymphocytic leukemia (CLL) as a monotherapy and in combination with obinutuzumab (NCT04245722).

About FT538FT538 is an investigational, universal, off-the-shelf natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered with three functional components: a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor, which has been modified to prevent its down-regulation and to enhance its binding to tumor-targeting antibodies; an IL-15 receptor fusion (IL-15RF) that augments NK cell activity; and the deletion of the CD38 gene (CD38KO), which promotes persistence and function in high oxidative stress environments. FT538 is designed to enhance innate immunity in cancer patients, where endogenous NK cells are typically diminished in both number and function due to prior treatment regimens and tumor suppressive mechanisms. In preclinical studies, FT538 has shown superior NK cell effector function, as compared to peripheral blood NK cells, with the potential to confer significant anti-tumor activity to patients through multiple mechanisms of action. FT538 is being investigated in a multi-dose Phase 1 clinical trial for the treatment of acute myeloid leukemia (AML) and in combination with daratumumab, a CD38-targeted monoclonal antibody therapy, for the treatment of multiple myeloma (NCT04614636).

About FT819FT819 is an investigational, universal, off-the-shelf, T-cell receptor (TCR)-less CD19 chimeric antigen receptor (CAR) T-cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line, which is engineered with the following features designed to improve the safety and efficacy of CAR19 T-cell therapy: a novel 1XX CAR signaling domain, which has been shown to extend T-cell effector function without eliciting exhaustion; integration of the CAR19 transgene directly into the T-cell receptor alpha constant (TRAC) locus, which has been shown to promote uniform CAR19 expression and enhanced T-cell potency; and complete bi-allelic disruption of TCR expression for the prevention of graft-versus-host disease (GvHD). FT819 demonstrated antigen-specific cytolytic activity in vitro against CD19-expressing leukemia and lymphoma cell lines comparable to that of primary CAR T cells, and persisted and maintained tumor clearance in the bone marrow in an in vivo disseminated xenograft model of lymphoblastic leukemia (Valamehr et al. 2020). FT819 is being investigated in a multi-center Phase 1 clinical trial for the treatment of relapsed / refractory B-cell malignancies, including B-cell lymphoma, chronic lymphocytic leukemia, and acute lymphoblastic leukemia (NCT04629729).

About Fate Therapeutics, Inc.Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class cellular immunotherapies for patients with cancer. The Company has established a leadership position in the clinical development and manufacture of universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell (iPSC) product platform. The Companys immuno-oncology pipeline includes off-the-shelf, iPSC-derived natural killer (NK) cell and T-cell product candidates, which are designed to synergize with well-established cancer therapies, including immune checkpoint inhibitors and monoclonal antibodies, and to target tumor-associated antigens using chimeric antigen receptors (CARs). Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit http://www.fatetherapeutics.com.

Forward-Looking Statements

This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 including statements regarding the Companys results of operations, financial condition and sufficiency of its cash and cash equivalents to fund its operations, as well as statements regarding the advancement of and plans related to its product candidates, clinical studies and preclinical research and development programs, the Companys progress, plans and timelines for the manufacture and clinical investigation of its product candidates, the timing for the Companys receipt of data from its clinical trials and preclinical studies, the initiation of additional clinical trials and additional dose cohorts in ongoing clinical trials of the Companys product candidates and the submission of IND applications for additional programs, the Companys development and regulatory strategy, the therapeutic and market potential of the Companys product candidates, and the parties rights and obligations under the Companys collaboration agreements. These and any other forward-looking statements in this release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that the Companys product candidates may not demonstrate the requisite safety or efficacy to achieve regulatory approval or to warrant further development, the risk that results observed in prior studies of the Companys product candidates, including preclinical studies and clinical trials, will not be observed in ongoing or future studies involving these product candidates, the risk of a delay or difficulties in the manufacturing of the Companys product candidates or in the initiation of, or enrollment of patients in, any clinical studies, the risk that the Company may cease or delay preclinical or clinical development of any of its product candidates for a variety of reasons (including requirements that may be imposed by regulatory authorities on the initiation or conduct of clinical trials, the amount and type of data to be generated, or otherwise to support regulatory approval, difficulties or delays in patient enrollment and continuation in the Companys ongoing and planned clinical trials, difficulties in manufacturing or supplying the Companys product candidates for clinical testing, and any adverse events or other negative results that may be observed during preclinical or clinical development), risks related to the impact of the COVID-19 pandemic on various aspects of the Companys business and operations, including its ability to initiate, conduct and complete its clinical trials, and the risk that the Companys expenditures may exceed current expectations for a variety of reasons. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Companys actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Companys periodic filings with the Securities and Exchange Commission, including but not limited to the Companys most recently filed periodic report, and from time to time in the Companys press releases and other investor communications.Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.

Availability of Other Information about Fate Therapeutics, Inc.Investors and others should note that the Company routinely communicates with investors and the public using its website (www.fatetherapeutics.com) and its investor relations website (ir.fatetherapeutics.com) including, without limitation, through the posting of investor presentations, SEC filings, press releases, public conference calls and webcasts on these websites. The information posted on these websites could be deemed to be material information. As a result, investors, the media, and others interested in Fate Therapeutics are encouraged to review this information on a regular basis. The contents of the Companys website, or any other website that may be accessed from the Companys website, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.

Condensed Consolidated Statements of Operations and Comprehensive Loss(in thousands, except share and per share data)(unaudited)

Condensed Consolidated Balance Sheets(in thousands)(unaudited)

Contact:Christina TartagliaStern Investor Relations, Inc.212.362.1200christina@sternir.com

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Fate Therapeutics Reports Second Quarter 2021 Financial Results and Highlights Operational Progress - StreetInsider.com

Acute Myeloid Leukemia

Historical complete response (CR)/CR with incomplete hematologic recovery rates with approved IDH inhibitors, enasidenib (Idhifa) and ivosidenib (Tibsovo), hover around 30% and have a median overall survival (OS) of approximately 9 months in the relapsed/refractory setting, said Shammo, a professor of medicine and pathology at Rush University Medical Center, in a virtual presentation during the2021 ASCO Direct HighlightsTMwebcast in Chicago, a program developed by Physicians Education Resource LLC.

Olutasidenib, a highly potent, orally active, selective IDH1 inhibitor, was developed to improve outcomes in the 7% to 14% of patients with AML who harbor IDH1 mutations.

In the phase 1/2 2102-HEM-101 trial (NCT02719574), 150 mg of oral olutasidenib was evaluated as a single agent and in combination with azacitidine across 8 cohorts of patients with acute myeloid leukemia (AML) and myelodysplastic syndromes. Findings from the planned interim analysis, which were presented during the 2021 ASCO Annual Meeting, focused on cohort 1, which enrolled 153 patients with relapsed/refractory, IDH1-mutant AML.1

In the efficacy-evaluable population (n = 123), 37% of patients had secondary AML, 73% of patients had intermediate cytogenetic risk, 44% of patients were refractory to their last line of therapy, and 11% had failed allogeneic stem cell transplant, reflecting a difficult population to treat, said Shammo.

The primary end point, CR/CR with partial hematologic recovery (CRh), was 33% (95% CI, 25.1%-42.4%), and most CR/CRh responders had a CR (30%; 95% CI, 22.1%-39.0%).

Transfusion independence was achieved in all response groups, particularly those achieving a CR, said Shammo.

The agent also demonstrated durable CR/CRh benefit, with a median duration of CR/CRh that was not reached and a median duration of response (DOR) of 11.7 months. In a sensitivity analysis with transplant considered as the end of a response, the median duration of CR/CRh response was 13.8 months.

Those who responded well had a much longer DOR, and a fraction of those patients managed to go onto stem cell transplant, which is what you would like to do in relapsed/refractory AML, said Shammo.

Better response was strongly associated with longer survival as well. At a median follow-up of 9.7 months, the median OS was not reached in patients who had achieved a CR/CRh, with an estimated 18-month OS rate of 87%. In the safety population (n = 153), the median OS was 10.5 months (95% CI, 7.7-15.5). Among nonCR/CRh responders and non-responders, the median OS was 15.0 months (95% CI, 5.0not evaluable) and 4.1 months (95% CI, 3.2-5.8), respectively.

Clinical benefit, as evidenced by DOR and OS, extended to patients who responded but did not achieve CR/CRh, said Shammo.

The primary treatment-emergent adverse effects (AEs) included leukocytosis (all-grade, 25%; grade 3/4, 9%) and febrile neutropenia (all-grade, 22%; grade 3/4, 20%), said Shammo. AEs of special interest reflected reports of differentiation syndrome (all-grade, 14%; grade 3/4, 7%), QTc prolongation (all-grade, 8%; grade 3/4, <1%), and liver abnormalities (all-grade, 21%; grade 3/4, 10%).

Olutasidenib was well tolerated with a safety profile largely consistent with that of other IDH inhibitors, but patients should be monitored for differentiation syndrome and liver abnormalities, said Shammo.

These results are very promising and very impressive, and, hopefully, we will see more results not only with the single agent but also with the combination with azacitidine in other myeloid malignancies, added Shammo.

Turning to acute lymphoblastic leukemia (AML), Shammo discussed the results of the phase 1/2 ZUMA-3 trial (NCT02614066), which evaluated the CD19-directed chimeric antigen receptor (CAR) T-cell therapy brexucabtagene autoleucel in patients with relapsed/refractory ALL.2

Approximately 40% to 50% of adults with B-ALL experience relapse after initial treatment, with a 1-year OS rate of 26% after first salvage therapy, said Shammo in explaining the rationale for the study.

In the phase 1 portion of the study, brexucabtagene autoleucel demonstrated a CR/CRi rate of 83% and manageable safety profile. In the phase 2 portion, 71 patients were enrolled, and 55 patients received brexucabtagene autoleucel.

Patients could have received prior treatment with blinatumomab (Blincyto) and underwent conditioning chemotherapy with fludarabine and cyclophosphamide prior to treatment with the recommended phase 2 dose of brexucabtagene autoleucel: 1 x 106 CAR T cells/kg.

Brexucabtagene autoleucel was successfully manufactured in 92% of patients, and the median time from leukapheresis to manufacturing release was 13 days for patients in the United States, which Shammo called remarkable.

Regarding baseline demographics, 27% of patients had Philadelphia chromosomepositive disease, 100% of which had central nervous system disease at baseline, and 47% of patients had received at least 3 lines of prior therapy.

Additionally, 45% of patients received prior blinatumomab, 42% underwent prior allogeneic transplant, and the median blast count was 65.0 and 59.0 at screening and preconditioning after bridging chemotherapy, respectively.

At a median follow-up of 16.4 months, the primary end point of CR/CRi rate by central assessment, was 70.9% (CR, 56.4%; CRi, 14.5%); 31% of responders were in ongoing remission at the data cutoff.

[We saw] a high and durable response rate in heavily pretreated adults with relapsed/refractory B-ALL, most of whom had high disease burden, said Shammo.

The median time to initial CR/CRi was 1.1 months. The minimal residual disease (MRD)negativity rate was 97% in responders, and 10 patients, including 9 with CR/CRi and 1 with blast-free hypoplastic or aplastic bone marrow underwent allogeneic transplant a median of 98 days (range, 60-207) following CAR T-cell infusion.

This is exactly what you would like to do: induce patients into remission to take them to allogeneic transplant, said Shammo. Whats remarkable is that MRD negativity in patients who had this treatment approximated 100%.

Among patients with CR/CRi (n = 39), the median OS was not reached (95% CI, 16.2-NE) and the median relapse-free survival (RFS) was 14.2 months (95% CI, 11.6-NE). All-treated patients (n = 39) had a median OS and RFS of 18.2 months (95% CI, 15.9-NE) and 11.6 months (95% CI, 2.7-15.5) respectively. Non-CR/CRi responders (n = 16) had a median OS and RFS of 2.4 months (95% CI, 0.7-NE) and 0.0 months (95% CI, NE-NE), respectively.

Regarding safety, any-grade cytokine release syndrome (CRS) occurred in 89% of patients, and grade 3 or higher CRS occurred in 24% of patients, with a median onset of 5 days and manifestation of pyrexia and hypotension.

Thats relatively favorable compared with what you might expect with [CAR T-cell therapy], said Shammo.

No cases of grade 5 CRS were reported, although 1 patient had grade brain herniation related to study treatment.

Any-grade neurologic events were reported in 60% of patients, and grade 3 or greater events occurred in 25% of patients, with a median onset of 9 days and manifestation of tremor and confused state.

Tocilizumab (Actemra), steroids, and vasopressors were given to 80%, 75%, and 40% of patients, respectively.

The safety profile was manageable, and AEs were largely reversible, said Shammo. The efficacy, rapid manufacturing, and manageable safety support the promising potential of brexucabtagene autoleucel to provide long-term clinical benefit in adults with relapsed/refractory B-ALL.

On April 2, 2021, a supplemental biologics license application was submitted to the FDA for brexucabtagene autoleucel as a treatment for adult patients with relapsed/refractory B-cell precursor ALL.3

If approved, brexucabtagene autoleucel would become the first and only CAR T-cell therapy approved for adults aged at least 18 years old with relapsed/refractory ALL.

The final study Shammo highlighted was the phase 2 OPTIC trial (NCT02467270), which evaluated 3 daily starting doses of ponatinib45 mg (n = 93), 30 mg (n = 93), and 15 mg (n = 91)in patients with chronic-phase chronic myeloid leukemia (CP-CML) resistant to a prior second-generation BCR-ABL1 TKI inhibitor or with a T315I mutation.4

Patients in the 45-mg and 35-mg arms were dose reduced to 15 mg daily upon achievement of 1% or less BCR-ABL1 and across arms were dose reduced to 10 mg daily in the presence of AEs.

Ponatinib, the only pan-BCR-ABL1 inhibitor, is a third-generation TKI designed to inhibit BCR-ABL1 with or without any single resistance mutation, including T315I.

In the pivotal, phase 2 PACE trial (NCT01207440), ponatinib demonstrated deep and durable responses to 45 mg of ponatinib in patients with resistant and intolerant CP-CML. However, a high incidence of arterial occlusive events (AOEs) was reported in the study, thought to be dose dependent, which ultimately compromised the utility of the drug, said Shammo.

[OPTIC] asked what dose is needed to be sure that the patients disease is under control and that perhaps we had mitigated the AOEs, said Shammo.

Notably, more than half of patients across dose cohorts had received at least 3 prior TKIs, and approximately a quarter of patients had a T315I mutation, said Shammo.

At a median follow-up of 32 months, the percentage of patients with 1% or less BCR-ABL1 at 12 months was 44.1% (95% CI, 31.7%-57.0%), 29.0% (95% CI, 18.4%-41.6%), and 23.1% (95% CI, 13.4%-35.3%) in the 45-mg, 30-mg, and 15-mg cohorts, respectively.

In the 30-mg and 15-mg cohorts, patients with less-resistant disease and without a T315I mutation at baseline had greater benefit than those with [a] T315I [mutation], said Shammo.

The 3-year OS probabilities were very reasonable, said Shammo, at 89.29%, 88.58%, and 91.71%, respectively. Notably, robust survival outcomes were reported in patients with and without BCR-ABL1 mutations, said Shammo.

What was interesting is that if you had the T315I mutation at baseline, you do need the 45-mg dose, because the response rates [with that dose] seem to be so much better than [those] patients who received a lower dose of ponatinib, said Shammo.

In terms of safety, any-grade treatment-emergent AOEs occurred in 9.6% of patients in the 45-mg arm, 5.3% in the 30-mg arm, and 3.2% in the 15-mg arm; grade 3 or greater rates occurred in 5.3%, 5.3%, and 3.2% of patients, respectively.

At this primary analysis, novel response-based ponatinib dosing regimens had clinically manageable safety and AOE profiles, with an optimal benefit-risk profile achieved with a 45-mg starting dose reduced to 15 mg upon response, concluded Shammo.

More:
IDH1 Inhibitors, CAR T-Cell Therapy, and Third-Generation TKIs Refresh Relapsed/Refractory Leukemia Landscape - OncLive

The updated report on the Animal Stem Cell Therapy market gives a precise analysis of the value chain assessment for the review period of 2021 to 2027. The research includes an exhaustive evaluation of the administration of the key market companies and their revenue-generating business strategies adopted by them to drive sustainable business. The Animal Stem Cell Therapy industry report further enlists the market shortcomings, stability, growth drivers, restraining factors, opportunities for the projected timeframe.

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The top companies in this report include:

Medivet Biologics LLC, VETSTEM BIOPHARMA, J-ARM, U.S. Stem Cell, Inc, VetCell Therapeutics, Celavet Inc., Magellan Stem Cells, Kintaro Cells Power, Animal Stem Care, Animal Cell Therapies, Cell Therapy Sciences, Animacel

The Global Animal Stem Cell Therapy market is expected to register a prominent% of market expansion during the review period owing to the largest market value in 2019. The market study provides a measure of the effectiveness of the product, real-time Animal Stem Cell Therapy market scenario, along custom ease. The study further offers market analysis, strategies and planning, R & D landscape, target audience management, market potential, due diligence, and competitive landscape.

Market Segmentation

Segment By Type

Dogs Stem Cell Therapy, Horses Stem Cell Therapy, Others Animals

Segment By Application

Veterinary Hospitals, Research Organizations

Scope of the report

A thorough analysis of statistics about the current as well as emerging trends offers clarity regarding the Animal Stem Cell Therapy market dynamics. The report includes Porters Five Forces to analyze the prominence of various features such as the understanding of both the suppliers and customers, risks posed by various agents, the strength of competition, and promising emerging businesspersons to understand a valuable resource. Also, the report spans the Animal Stem Cell Therapy research data of various companies, benefits, gross margin, strategic decisions of the worldwide market, and more through tables, charts, and infographics.

The Animal Stem Cell Therapy report highlights an all-inclusive assessment of the revenue generated by the various segments across different regions for the forecast period, 2021 to 2027. To leverage business owners, gain a thorough understanding of the current momentum, the Animal Stem Cell Therapy research taps hard to find data on aspects including but not limited to demand and supply, distribution channel, and technology upgrades. Principally, the determination of strict government policies and regulations and government initiatives building the growth of the Animal Stem Cell Therapy market offers knowledge of what is in store for the business owners in the upcoming years.

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Geographic analysis

The global Animal Stem Cell Therapy market has been spread across North America, Europe, Asia-Pacific, the Middle East and Africa, and the rest of the world.

COVID-19 Impact Analysis

The pandemic of COVID-19 has emerged in lockdown across regions, line limitations, and breakdown of transportation organizations. Furthermore, the financial vulnerability Animal Stem Cell Therapy Market is a lot higher than past flare-ups like the extreme intense respiratory condition (SARS), avian influenza, pig influenza, bird influenza, and Ebola, inferable from the rising number of contaminated individuals and the vulnerability about the finish of the crisis. With the rapid rising cases, the worldwide Animal Stem Cell Therapy refreshments market is getting influenced from multiple points of view.

The accessibility of the labor force is by all accounts disturbing the inventory network of the worldwide Animal Stem Cell Therapy drinks market as the lockdown and the spread of the infection are pushing individuals to remain inside. The presentation of the Animal Stem Cell Therapy makers and the transportation of the products are associated. If the assembling movement is stopped, transportation and, likewise, the store network additionally stops. The stacking and dumping of the items, i.e., crude materials and results (fixings), which require a ton of labor, is likewise vigorously affected because of the pandemic. From the assembling plant entryway to the stockroom or from the distribution center to the end clients, i.e., application ventures, the whole Animal Stem Cell Therapy inventory network is seriously compromised because of the episode.

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Animal Stem Cell Therapy Market Research 2021-2027 With Medivet Biologics LLC, VETSTEM BIOPHARMA, J-ARM, US Stem Cell The Manomet Current - The...

Palm Coast, FL, Aug. 04, 2021 (GLOBE NEWSWIRE) -- After months of careful consideration, Gold River Productions, Inc. (OTC Pink: GRPS) (GRPS) opens its Rejuvenation Division and to welcome Michael Berkowitz as the newest member to the Gold River Team. His extensive background in the transformative field of cell-based therapy provides a significant pathway for sustainable revenue and directly compliments our new herbal formulations. With the coupling of our current product line and the considerable advances in stem cell therapeutic development, our direction brings viable attractive options to those suffering from an expansive range of degenerative conditions.

According to Fortune Business Insights, the global stem cells market is projected to grow from $11.90 billion in 2021 to $27.65 billion in 2028 at a CAGR of 12.8%. The factors contributing to the growth include increasing demand for biologics, technological advancement in pluripotential cell therapeutics, and a rising focus on the development of personalized medicines. The growing prevalence of chronic diseases worldwide is anticipated to boost demand through 2028.

As resourcing options are realized, the company intends to bring physical presence to these dynamic and unique options by offering a number of primary free-standing facilities to supply and educate our rapidly growing physician network.

Commenting as the newest member of the team, I am humbled by the support and dedication of Dr. Goulding and his associates at GRPS. Dr. Goulding shares my vision. Ive personally witnessed the effects that stem cells can have with appropriate administration and dosing in over 5000 cases, says Mr. Berkowitz, who will head the Rejuvenation Division of the GRPS subsidiary StemSpa. Ive worked with a number of universities and FDA approved manufacturers in recording and reporting data. Weve been involved in studies including M.S., joint issues, PTSD, and cancer. Im eager for the opportunity to continue and expand this with GRPS.

Story continues

Berkowitz continued, What intrigues me most about Dr. Bond and Dr. Goulding is how their products work in concert with pluripotential cells, and our InflammaplexTM formulation will serve as a foundation of support for the cells. Furthermore, almost anyone seeking relief will require adjunctive anti-inflammatory products for their pain and underlying issues. Empowering doctors with these unique adjuvants and giving their patients access to more preferable choices will be a game-changer.

Continuing, he stated, We are in negotiations to construct stand-alone facilities in strategic locations to establish StemSpa, which will serve as centers of excellence in the United States and offshore. We will begin with approximately 1000 doctors thanks to the relationship built between GRPS, heliosDx, and CEO Ashley Sweat of Rushnet (OTC Pink: RSHN). Im very excited to have doctors in this continuously expanding group utilize our inflammatory-reducing product line and have our technology at their fingertips. This will offer an amazing alternative to their patients as well as help us develop broad data collection and deliver data that these biologics are not only effective, but in the right hands and with the right techniques, possess endless possibilities to those suffering.

We are excited to have Mr. Berkowitz on board, says Richard Goulding, M.D., Chairman of the Board of GRPS. Mr. Berkowitz has been involved with over 5000 cases utilizing biologics and pluripotential cells and has a great deal of experience not only procuring appropriate cells, but in targeting specific concerns. The amount of video footage and anecdotal evidence is quite compelling. Theres a tremendous fit here, and the possibilities are exciting. Furthermore, we suspect that, with the proper base of nutrient support, we are optimizing the conditions for obtaining maximum efficacy with these techniques. We intend to be an industry leader for proper technique, procurement, and nutritional support in this complex field.

About Gold River Productions, Inc. Dedicated to changing peoples lives, Gold River is a groundbreaking company aiming at improving quality of life and longevity. Our diverse products and interests include nutraceuticals, CBD, land, education and more. With a unique staff of talented physicians, cultivators, and CBD experts, we are poised to tackle different disease states at an unprecedented level. Utilizing years of experience in herbals, rare cannabinoids, traditional and non-traditional methods of patient care, we are in the unique position to utilize CBD and herbals in the most effective ways possible. Emphasis on what already works, then augmenting effective formulas with high-quality cannabinoids in therapeutic levels, can achieve unprecedented symptom control in a myriad of disease states.

This document contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are subject to a number of risks and uncertainties, many of which are outside Gold Rivers control. These include but are not limited to the impact of competitors products, services and pricing; product demand; market acceptance; new product development; reliance on key strategic alliances; the regulatory environment; fluctuations in operating results; and other risks which are detailed from time to time in the Companys filings with the Securities and Exchange Commission and/or OTC Markets. Gold River Productions disclaims any obligation to update or alter its forward-looking statements whether as a result of new information, subsequent events or otherwise.

CONTACT: Gold River Productions, Inc.info@grpsinc.com http://www.GRPSInc.com

About heliosDx: heliosDX is a National Clinical Reference Laboratory offering High-Complexity Urine Drug Testing (UDT), Behavioral Drug Testing, Allergy Droplet Cards, Oral Fluids, Infectious Disease (PCR), and NGS Genetic Testing. We are contracted in 44 of the lower 48 states and looking to expand our reach and capabilities. Always staying ahead of the curve, by continually investing in our infrastructure with the most efficient scientific proven instruments, and latest cutting-edge software for patient and physician satisfaction. This allows heliosDX to provide physicians fast and accurate reporting meeting and exceeding industry benchmarks. We excel in patient and client care through physician designed panels that aid in testing compliance and reporting education.

Contact: Ashley Sweatasweat@heliosdx.comwww.heliosdx.com (Under Development)@dx_helios

Continued here:
Gold River Productions, Inc. (GRPS) Appoints Michael Berkowitz to spearhead the Rejuvenation Division with StemSpa - Yahoo Finance

TheGlobal Stem Cell Therapy Market To Garner Immense Returns Over 2020-2026A fundamental outline of theStem Cell Therapy Marketniche is presented by the Stem Cell Therapy Market report that entails definitions, classifications, applications together with industry chain framework. TheStem Cell Therapy Marketreport provides a far-reaching evaluation of necessary market dynamics and the latest trends. It also highlights the regional market, the prominent market players, as well as several market segments [Product, Applications, End-Users, and Major Regions], and sub-segments with a wide-ranging consideration of numerous divisions with their applications.

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Some of the Major Market Players Are:

Anterogen Co., Ltd., RTI SurgicalInc., Pharmicell Co., Ltd., MEDIPOST Co., Ltd., JCR Pharmaceuticals Co., Ltd., Holostem Terapie Avanzate S.r.l., NuVasiveInc., and AlloSource.

Further, the report acknowledges that in these growing and promptly enhancing market circumstances, the most recent advertising and marketing details are very important to determine the performance in the forecast period and make essential choices for profitability and growth of the Stem Cell Therapy Market. In addition, the report encompasses an array of factors that impact the growth of the Stem Cell Therapy Market in the forecast period. Further, this specific analysis also determines the impact on the individual segments of the market.

Furthermore, the study assessed major market elements, covering the cost, capacity utilization rate, growth rate, capacity, production, gross, usage, revenue, export, supply, price, market share, gross margin, import, and demand. In addition, the study offers a thorough segmentation of the global Stem Cell Therapy Market on the basis of geography [ Latin America, North America, Asia Pacific, Middle & East Africa, and Europe] , technology, end-users, applications, and region.

The Stem Cell Therapy Market report is a collection of pragmatic information, quantitative and qualitative estimation by industry experts, the contribution from industry connoisseurs and industry accomplices across the value chain. Furthermore, the report also provides the qualitative results of diverse market factors on its geographies and segments.

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The Stem Cell Therapy Market report is an appropriate compilation of all necessary data for the residential, industrial. & commercials buyers, manufacturers, governments, and other stakeholders to implement their market-centric tactics in line with the projected as well as the prevailing trends in the Stem Cell Therapy Market. Apart from this, the report also provides insightful particulars of the existing policies, laws, together with guidelines.

Promising Regions & Countries Mentioned In The Stem Cell Therapy Market Report:

Chapters Covered in Research Report are :

Chapter 1,2 :The goal of global Stem Cell Therapy Market covering the market introduction, product image, market summary and development scope.

Chapter 3, 4 :Global Market Competitions by Manufacturers, Sales Volume and Market Profit.

Chapter 5,6,7:Global Supply (Production), Consumption, Export, Import by Regions like United States, Asia-Pacific, China, India, Japan. Conducts the region-wise study of the market based on the sales ratio in each region, and market share from 2021to 2027

Chapter 8,9,10:Global Market Analysis by Application, Cost Analysis, Marketing Strategy Analysis, Distributors/Traders

Chapter 11,12 :Market information and study conclusions, appendix and data sources.

The market report also identifies further useful and usable information about the industry mainly includes Stem Cell Therapy Market development trend analysis, investment return and feasibility analysis. Further, SWOT analysis is deployed in the report to analyze the key global market players growth in the Stem Cell Therapy Market industry

Inquire more about this report @https://www.zionmarketresearch.com/inquiry/stem-cell-therapy-market

Purposes Behind Buying Stem Cell Therapy Market Report:-

Key questions answered in this comprehensive study Global Stem Cell Therapy Market Size, Status and Forecast 2026

Also, Research Report Examines:

Thanks for reading this article; you can also get individual chapter wise section or region wise report version like North America, Europe or Asia.

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