16 June 2021 - - US-based biopharmaceutical company Organicell Regenerative Medicine, Inc. (OTC: BPSR) has posted the outcome of their expanded access intermediate size patient population trial (NCT04657406), the company said.

According to the company, the trial met endpoints for safety and efficacy in patients with mild to moderate COVID-19.

The treatment mitigated mild and moderate symptoms; improved pulmonary opacities detected in chest X-rays; and improved inflammatory biomarkers.

The trial was conducted at United Memorial Medical Center in Houston, TX. The administration of Zofin was well tolerated in all enrolled subjects, with no adverse events.

Chest X-ray data demonstrated that 75% of subjects had bilateral opacities caused by COVID-19 infection at day 0 (baseline), prior to Zofin treatment.

Thirty days after Zofin treatment, chest X-ray data showed 83% of treated subjects had normal lung imaging, indicating complete recovery.

There was also a significant decrease in biomarker levels like CRP, IL-6, and TNF-α at day 14, 21, and 30 when compared to the respective control with p-values less than p < 0.05, p < 0.01 and p < 0.001, respectively.

Organicell intends to submit results for scientific peer review and publication.

Organicell will immediately submit this data to the FDA for a requested amendment to their approved IND (NCT04384445) to perform a placebo-controlled Phase 2 clinical trial to confirm safety and efficacy in a randomized fashion.

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 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.

Organicell Regenerative Medicine, Inc. (OTC: BPSR) is a clinical-stage biopharmaceutical company that harnesses the power of exosomes to develop innovative biological therapeutics for the treatment of degenerative diseases.