ORGANICELL™ REGENERATIVE MEDICINE
OUR COVID-19 PROGRAM UPDATE
Organicell Regenerative Medicine, Inc. (OTCMKTS: BPSR) is the leading clinical-stage biopharmaceutical and regenerative medicine company dedicated to the development of regenerative therapies. Organicell™ has recently completed enrollment of our phase I/II expanded access clinical trial using our investigational new drug (IND) and lead product, Zofin™. The expanded access protocol provided access to Zofin for patients in outpatient and inpatient facilities infected with SARS-CoV-2 who have mild to moderate COVID-19 infection, or who are judged by a healthcare provider to be at high risk of progression to moderate disease. The trial is being conducted at the United Memorial Medical Center in Houston, TX.
In addition to completing multiple emergency INDs under our parent IND, our multi-center, randomized, double-blinded, placebo-controlled phase I/II clinical trial is actively enrolling. This trial is being conducted to investigate the safety and potential efficacy of intravenous infusion of Zofin™ for the treatment of moderate to severe acute respiratory syndrome (SARS) related to COVID-19.
Organicell is committed to completing our FDA-approved clinical trials as we hope to develop an FDA-approved treatment option targeted to patients suffering from COVID-19.
THE NEXT GENERATION OF
BIOLOGIC MEDICINE
PROGRAM UPDATES
We believe that our ground-breaking research in the field of nanotechnology, specifically extracellular vesicles and perinatal-derived nanoparticles, has created a drug candidate that is the next frontier of regenerative biologic drug therapeutics. Organicell™ is committed to creating life changing and lifesaving therapies for patients.
OSTEOARTHRITIS (OA)
Organicell Regenerative Medicine, Inc., received approval from the U.S. Food and Drug Administration (FDA) for an Investigational New Drug (IND) application on our lead product, Zofin™, in the treatment of knee osteoarthritis. This approved trial design, which will begin in the second quarter of this year, will be a double blinded, placebo-controlled, phase I/II trial investigating the safety and potential efficacy of Zofin™ for patients suffering with knee osteoarthritis.
Chronic Obstructive Pulmonary Disease (COPD)
Organicell Regenerative Medicine, Inc., received approval from the U.S. Food and Drug Administration (FDA) for an Investigational New Drug (IND) application on our lead product, Zofin™, in the treatment of patients diagnosed with COPD. This approved trial design will be a double blinded, placebo-controlled, phase I/II trial investigating the safety and potential efficacy of intravenous infusion (IV) of Zofin™ for the treatment of COPD.
