Miami, FL (September 29, 2020) – Organicell Regenerative Medicine, Inc. (OTCBB: BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, announced that the U.S. Food and Drug Administration (FDA) granted expanded access for an intermediate size population allowing its proprietary therapeutic, Zofin for the treatment of COVID-19. [Read more…]
FDA Grants RMAT to MultiStem Cell Therapy for Treatment of ARDS
ARDS program well-positioned for an expedited path to commercialization with RMAT and Fast Track designation
September 23, 2020; Cleveland — Athersys, a leading regenerative medicine company in late-stage clinical development, announced today that MultiStem® cell therapy was granted Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. FDA for the acute respiratory distress syndrome (ARDS) program. [Read more…]
Organicell Phase I/II Clinical Trial Update
Lead Therapeutic Candidate To Be Named Zofin(TM)
Miami, FL (August 18, 2020) — Organicell Regenerative Medicine, Inc. (OTCBB: BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, announced today that it has partnered with Alternative Research Associates, LLC and Larkin Hospital in Miami, FL to initiate a randomized, double-blinded, placebo-controlled phase I/II clinical trial against COVID-19 of its lead therapeutic candidate, which has been rebranded as Zofin. [Read more…]
Direct Biologics Receives FDA Approval to Initiate ‘EXIT COVID-19,’ a Phase II Investigational New Drug Trial with ExoFlo™
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…]
GIOSTAR Reports on a Positive Outcome of a COVID-19 Patient After Stem Cell Treatment
Promising results point to a potential alternative in combating the pandemic
San Diego, July 28, 2020 — Global Institute of Stem Cell Therapy and Research (GIOSTAR), the worldwide leader in stem cell research, is pleased to announce the outcome of a COVID-19 patient treated using stem cells. Led by Chairman and Co-Founder Dr. Anand Srivastava, GIOSTAR received approval for the treatment under the U.S. Food and Drug Administration (FDA) “expanded access for compassionate use” program. As of July 14, 2020, there have been more than 13 million COVID-19 cases and over 500,000 deaths worldwide. [Read more…]
