Policy & Regulation
Organicell Adds Site for Phase I/II Clinical Trial of Zofin for Treatment of COVID-19
19 November 2020 - - US-based biopharmaceutical company Organicell Regenerative Medicine, Inc. (OTCBB: BPSR) is now enrolling patients at an additional site, Larkin Hospital North located in Hialeah, Florida for its Phase I/I clinical trial for the use of its Zofin therapeutic in treatment of COVID-19, the company said.

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 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.

Organicell Regenerative Medicine 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.

Larkin Community Hospital is an integrated healthcare delivery system accredited by the Joint Commission with locations in South Miami, Hialeah and Hollywood, Florida.

Its 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.

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.
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