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…]
Three New COVID-19 Patients Treated with Zofin(TM) Report Improvement
Organicell Commences Phase I/II Clinical Trial Enrollment
Miami, FL (September 2, 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 emergency, expanded access approval to treat two mild to moderate COVID-19 patients and one “Long Hauler” post COVID-19 patient. [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…]
FDA Approves Two Emergency INDs for COVID-19 Outpatient Therapy
First Reported eIND Issued for Outpatient COVID-19 Therapy
Miami, FL (August 6, 2020) — Organicell Regenerative Medicine, Inc. (OTCBB: BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, announced today that the U.S. Food and Drug Administration (FDA) approved two outpatient Emergency Investigational New Drug Applications (eINDs) for treating mild to moderate respiratory distress due to COVID-19. [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…]
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