MIAMI--(BUSINESS WIRE)--Organicell Regenerative Medicine, Inc. (OTCMKTS: BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, today announced its Zofin™ therapy has been approved by Pakistani regulators to be used for a COVID-19 patient on compassionate grounds.
The Drug Regulatory Authority of Pakistan has approved Zofin™ for use with a named patient on compassionate grounds following the patient’s COVID-19 diagnosis and admittance to an intensive care unit for treatment on a ventilator. Treatment with Zofin™ will take place at the Pakistan Institute of Medical Sciences (PIMS). The approval by regulators is contingent on the strict adherence to the dosing protocols in use by clinical trial investigators conducting Organicell’s ongoing Phase I/II trial for COVID-19.
In addition to this compassionate grounds authorization, Organicell has received further authorization to begin a broader trial of Zofin™ with up to 60 additional patients suffering from moderate to severe COVID. The Company has already shared data with regulatory authorities in the country in support of this effort and hopes to come to an arrangement and commence this trial in the near future.
“Organicell is dedicated to helping those who suffer from COVID-19 and are hopeful that Zofin™ can continue to help these patients in Pakistan,” said Albert Mitrani, CEO of Organicell. “Starting with this first patient who will be treated on compassionate grounds, we are eager for this opportunity to begin the trial which hopefully will lead to a fast authorization of Zofin to be used as the COVID-19 treatment protocol.”
“We are touched by the compassion and care of Organicell for sharing their research product, Zofin™, based on the science involving exosomes. With their generous help and extraordinary efforts, we will be starting the trial of this medicine at one of the biggest Medical Institutes of Pakistan,” said Dr. Rana Imran Sikanadar, Head of Anesthesia and Critical Care Medicine at PIMS.
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.
ABOUT ORGANICELL REGENERATIVE MEDICINE, INC.
Organicell Regenerative Medicine, Inc. (OTCMKTS: BPSR) is a clinical-stage biopharmaceutical company that harnesses the power of exosomes 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 exosomes, hyaluronic acid, and proteins 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. Mari Mitrani, Chief Scientific Officer. To learn more, please visit https://organicell.com/.
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