Organicell-CWI to seek ICMR approval for emergency use of Zofin™
South Florida-based Organicell Regenerative Medicine, Inc. (OTCMKTS: BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, has announced positive results for the first 10 COVID-19 patients treated with Zofin™ in India.
This initial trial is being conducted in conjunction with Organicell’s Indian partner, CWI India, with whom Organicell entered into a product testing and distribution agreement on February 9, 2021 to study the effects of Zofin™ on moderate to severe COVID-19 patients.
The initial ten trial participants were hospitalized patients and were treated at Narayana Hrudayalaya Hospital in Bangalore, Lisa Hospital in Kozhikode, Kerala and Prime Indian Hospital in Chennai, and all patients have recovered from their symptoms and have since been discharged from the hospital.
Based on the initial results of this trial, the trial will be expanded to an additional 65 patients with moderate to severe COVID-19, who will be treated at these hospitals over the next several weeks, with treatments expected to be completed by the end of June 2021, said Organicell in a release on 28 April 2021 from Miami.
If the results of the expanded trial are similarly positive, Organicell and CWI India, intend to file with the ICMR (Indian Council for Medical Research) for Emergency Use Approval to use Zofin™ in India as a therapeutic for treating COVID-19.
The Indian Health Ministry is reporting more than 350,000 new COVID infections and over 2,500 deaths per day, a world record, and India is now seeing more new infections than any other country, almost half of all new cases in a global surge.
“The explosive spread of COVID-19 in India, and the lack of treatment that is available to help these millions of people is quite alarming and tragic. We are hopeful that Zofin™ can continue to help these patients, and we will do everything we can to expedite this process,” said Albert Mitrani, CEO of Organicell.
“We are very encouraged with the results shown by patients using Zofin™ and are hopeful that the remaining trial patients will show similar results. These trials could set the stage for a very quick Emergency Use Approval to be able to use Zofin™ for all of our patients,” said Doctor Matthew Roshan of CWI India.
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.
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. It was founded in 2008 by Albert Mitrani, Chief Executive Officer and Dr. Mari Mitrani, Chief Scientific Officer. #health #Covid-19 #virus #medicines /fiinews.com
