AUSTIN, Texas — Direct Biologics, LLC, is announcing that it has received approval from FDA that it may proceed with a Phase II trial under an Investigational New Drug (IND) application for the use of ExoFlo™, a bone marrow-derived extracellular vesicle and exosome product, in the treatment of COVID-19 associated Acute Respiratory Distress Syndrome (ARDS). The ExoFlo Infusion Treatment for COVID-19 (EXIT COVID-19) Associated ARDS trial will be a multi-center, double-blind, randomized, placebo-controlled clinical trial. [Read more…]
Stem Cell News
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Vita Therapeutics Receives Orphan Drug Designation from FDA for Allogenic iPSC-based Therapy
BALTIMORE, July 23, 2020 — Vita Therapeutics, Inc. has received orphan drug designation (ODD) from the U.S. Food and Drug Administration (FDA) for VTA-110, a novel regenerative therapy for the treatment of Duchenne’s Muscular Dystrophy (DMD).
VTA-110, is a potential first-in-class allogenic iPSC-based therapy that has shown the ability to repair and regenerate healthy muscle in preclinical studies and has the potential to benefit patients with DMD. [Read more…]
Former Yahoo! Chairman, Wall Street Titan Roy J. Bostock Joins GID BIO as Chairman
Bostock joins late-stage biotech as pivotal Phase III trial gets underway for cellular therapy for osteoarthritis of the knee
LOUISVILLE, Colo., July 28, 2020 — Roy J. Bostock, former Chairman of Yahoo!, Vice Chairman of Delta Airlines and a director of Morgan Stanley, has joined the cellular medicine startup GID BIO that has a potentially break-through treatment for osteoarthritis in late-stage regulatory review. Bostock was elected chairman of the board to succeed J. William Futrell, M.D., co-founder and chairman since 2011 who will continue as a board director. [Read more…]
Cynata Receives Ethics Approval to Commence Clinical Trial in COVID-19 and Clinical Development Update
MELBOURNE, Australia, May 08, 2020 — Cynata Therapeutics Limited (ASX: “CYP”, “Cynata”, or the “Company”), a clinical-stage biotechnology company specialising in cell therapeutics, is pleased to announce that it has received ethics committee approval to commence a clinical trial to investigate early efficacy of Cynata’s proprietary Cymerus™ mesenchymal stem cells (MSCs) in adults admitted to intensive care with COVID-19. In addition, the Company also provides updated guidance on its wider clinical development pipeline. [Read more…]
Fate Therapeutics Gets FDA Clearance of IND Application for World’s First iPSC-derived CAR T-Cell Therapy
FT819 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 FT819 for Patients with Advanced B-cell Leukemias and Lymphomas
SAN DIEGO, July 09, 2020 — Fate Therapeutics, Inc. (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for FT819, an off-the-shelf allogeneic 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, and is engineered with several first-of-kind features designed to improve the safety and efficacy of CAR T-cell therapy. [Read more…]
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