Research & Development
Organicell wins FDA's approval for IND Zofin
22 July 2021 -

Biopharmaceutical company Organicell Regenerative Medicine Inc (OTCMKTS:BPSR) reported on Wednesday the receipt of approval from the US Food and Drug Administration (FDA) for the Investigational New Drug (IND) application for its lead product Zofin for the treatment of prolonged COVID-19 symptoms (long haulers).

Zofin is an acellular biologic therapeutic derived from perinatal sources and retains the natural microRNAs. The product contains 300 growth factors, cytokines, and chemokines as well as extracellular vesicles/nanoparticles derived from perinatal tissues, added the company.

This US FDA approval is based on the double blinded, placebo-controlled, randomized phase I/II trial designed to investigate the safety and potential efficacy of Zofin in treating COVID-19 long haulers. It plans to begin the study during the third calendar quarter of this year. The clinical research team will collect and analyze the data obtained from the long haulers study.

With most COVID-19 patients recovering completely within a few weeks, some patients, called COVID-19 long haulers, report lingering shortness of breath, cough, fatigue and mental fog for months after recovery, impairing their return to work and everyday life, concluded the company.



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