Miami, FL (November 18, 2020) – Organicell Regenerative Medicine, Inc. (OTCBB: BPSR), a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, announced today that it is now enrolling patients at an additional site, Larkin Hospital North located in Hialeah, Florida for its Phase I/II clinical trial for the use of its Zofin™ therapeutic in treatment of COVID-19.
This multi-center, randomized, double-blinded, placebo-controlled phase I/II clinical 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. The study will be enrolling 20 participants. As of November 17, 2020, several patients have already begun treatment at Larkin Hospital South, located in South Miami, Florida.
“The addition of this clinical trial site is another step towards determining whether to apply for FDA approval for the use of Zofin™ as a COVID-19 treatment, and increases our capacity for participating patients in order to finalize this clinical trial by year’s end,” said Albert Mitrani, Chief Executive Officer of Organicell.
“To date, we have successfully enrolled several patients who have begun treatment in this trial, with no reported serious adverse events. We are looking forward to continued progress as we enroll additional patients in the coming weeks. Most of all, we are eager to begin enrollment at Larkin Community Hospital North this week,” said Dr. Luis Mendez-Mulet, Infectious Disease Specialist at Alternative Research Associates and Larkin Community Hospital.
“We are excited to sign on Larkin Hospital North as a second clinical trial site. We look forward to working with their research team as we advance our trial for using Zofin™ to treat moderate to severe acute respiratory syndrome due to COVID-19,” said Dr. Maria Ines Mitrani, Chief Science Officer of Organicell.
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/.
About Larkin Hospital
Larkin Community Hospital is an integrated healthcare delivery system accredited by the Joint Commission with locations in South Miami, Hialeah and Hollywood, Florida. Our network of acute care hospitals provides a complete continuum of healthcare services, including a full range of inpatient and outpatient services, home health agencies, Skilled Nursing facilities, Rehab centers and Assisted Living facilities in Miami-Dade and Broward County. To learn more, please visit
http://larkinhospital.com/.
About ZofinTM
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.