FDA Gives Green Light to Clinical Trial of Zofin

The U.S. Food and Drug Administration (FDA) has granted Organicell Regenerative Medicine permission to begin a clinical trial testing the company’s lead product, Zofin, in people with chronic obstructive pulmonary disease (COPD).

The approved trial design will be a double-blinded, placebo-controlled, phase 1/2 trial to assess the safety and effectiveness of Zofin, delivered by intravenous (into-the-bloodstream) infusion, as a potential COPD treatment.

“COPD is a chronic, degenerative, inflammatory lung disease with no current cure. We are excited to initiate this FDA approved clinical trial and to further explore the potential of Zofin in battling this disease,” Mari Mitrani, MD, PhD, chief science officer of Organicell, said in a press release.

Zofin is a non-cellular biological therapeutic that is derived from amniotic fluid collected at childbirth. (Amniotic fluid surrounds a developing fetus in the womb.) The investigational therapy is manufactured to retain important natural signaling molecules, without the addition or combination of other substances.

Zofin is believed to work due to the extracellular vesicles it contains and that can deliver microRNAs to the body’s cells. Extracellular vesicles, sometimes called EVs, are essentially packets of cellular material wrapped in a membrane. Many different types of cells release EVs; the exact content of any particular EV is dependent on the type of cell that released it, as well as other biological factors (e.g., inflammation).

EVs are able to deliver cargo to cells, which influences the activity of the recipient cell; it’s sort of like communicating by sending a message in a bottle. The main active cargo in Zofin is believed to be microRNAs, which are small RNA molecules that help to regulate the activity of different genes within cells.

The concept is that by delivering these particular microRNAs through EVs, Zofin will induce changes in cellular behavior that lessen disease-associated biological processes and, as such, diminish disease activity and ease symptoms.

Most notably, Zofin is believed to lessen inflammatory processes, which are involved in the progression of COPD and other respiratory diseases.

In addition to COPD, Zofin is being developed as a potential treatment for other conditions, including COVID-19. Three people with COVID-19 have already been treated with the investigational therapy, after emergency approval for these specific cases was granted by the FDA.

According to Organicell, the clinical status of these patients improved, including their respiratory health.