Organicell Regenerative Medicine, a clinical-stage biopharmaceutical company dedicated to the development of regenerative therapies, announced today that the U.S. Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for its lead product, Zofin™, for the treatment of ‘Prolonged COVID-19 Symptoms’ (“Long Haulers”).
This approved trial design consists of a 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. The Company is planning to begin the study during the third calendar quarter of this year, subject to the successful negotiation and execution of definitive agreements with the site facility where the study patients will be treated and the clinical research organization that will collect and analyze the data obtained from the study and the Company raising sufficient working capital to finance the trial, as to all of which no assurance can be given.
As COVID-19 infections occur (and resolve) globally, it is becoming increasingly apparent that not all cases of COVID-19 fit into “mild” or “critical” categories or resolve in the typical 2-3 week time frame. While most recover completely within a few weeks, some continue to experience symptoms beyond their initial recovery. These 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. Even by the lowest health care industry estimates, the magnitude of this secondary health crisis of COVID-19 long haulers will result in millions of affected individuals.
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 growth factors, cytokines, chemokines, and 102 unique microRNAs as well as other exosomes/nanoparticles derived from perinatal tissues.
“Organicell is committed to developing a therapeutic to address both the immediate challenges of the COVID-19 pandemic and the long-term challenges associated with post-COVID-19 patient conditions,” said Albert Mitrani, Chief Executive Officer of Organicell.
“Although COVID-19 is seen as a disease that primarily affects the lungs, it is also a systemic inflammatory disease involving the endothelium surrounding blood vessels and organs throughout the body, thereby damaging many other organs,” said Dr. George Shapiro, M.D., F.A.C.C., Chief Medical Officer of Organicell.
“Many long-term COVID-19 effects are still unknown. Thus, there is an urgent need to develop new therapies to manage post-acute sequelae SARS-CoV-2 infection (PASC), and to support patients experiencing delayed morbidity and resulting disability,” said Dr. Mari Mitrani, M.D., Ph.D., Chief Science Officer of Organicell.
Source – PR Newswire