Anticipates Phase I/II trial completion by end of year
Anticipates Phase IIb trial to begin in Q1 2021
Seeks to retain a global contract research organization (“CRO”)
Miami, FL (November 12, 2020) – Organicell Regenerative Medicine, Inc. (OTCBB: BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, today provided an update on its Phase I/II clinical trial for treatment of COVID-19 using Organicell’s proprietary therapeutic, Zofin™, which is currently underway as well as an update on its expanded access protocol for outpatients with COVID-19.
The Company’s current Phase I/II clinical trial which commenced on September 8, 2020, is a randomized, double-blinded, placebo-controlled phase I/II trial designed to investigate its proprietary therapeutic, Zofin™, as a potential treatment for moderate to severe acute respiratory syndrome (SARS) related to COVID-19. To date, several patients have been enrolled, dosed and treated at Larkin Hospital in Miami, Florida. Organicell expects to finish enrollment and complete the trial by December 31, 2020. It is the Company’s intention, subject to favorable results, careful data analysis, discussion with and approvals from the FDA, to begin a Phase IIb confirmatory trial as early as the first quarter of 2021.
In September 2020, Organicell announced that the FDA granted it an expanded access protocol. This protocol allows Organicell to provide Zofin™ to a certain amount of mild to moderate COVID-19 patients in both outpatient and inpatient settings.
In connection with its planned Phase IIb confirmatory trial, the Company is negotiating an agreement with a nationally known CRO to support the needed services related to running its clinical trials. The Company expects this agreement to be finalized in the coming days.
“We’re very pleased in the progress we are making in our clinical trials,” said Albert Mitrani, Chief Executive Officer of Organicell. “Our planned CRO partnership is intended to support our efforts to efficiently and expeditiously conduct our clinical trial programs which, if successful, may ultimately afford a potentially effective treatment for patients suffering from the effects of COVID-19.”
About Organicell Regenerative Medicine, Inc.
Organicell Regenerative Medicine, Inc. is a clinical-stage biopharmaceutical company that harnesses the power of nanoparticles to develop innovative biological therapeutics for the treatment of degenerative diseases. The company’s proprietary products are derived from perinatal sources and manufactured to retain the naturally occurring microRNAs, without the addition or combination of any other substance or diluent. Based in South Florida, the company was founded in 2008 by Albert Mitrani, Chief Executive Officer and Dr. Maria Ines Mitrani, Chief Science Officer. To learn more, please visit https://organicell.com/.
Zofin is an acellular biologic therapeutic derived from perinatal sources and is manufactured to retain naturally occurring microRNAs, without the addition or combination of any other substance or diluent. This product contains over 300 growth factors, cytokines, and chemokines as well as other extracellular vesicles/nanoparticles derived from perinatal tissues. Zofin is currently being tested in a phase I/II randomized, double blinded, placebo trial to evaluate the safety and potential efficacy of intravenous infusion of Zofin for the treatment of moderate to SARS related to COVID-19 infection vs placebo.