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™, in the treatment of knee osteoarthritis.
This approved trial design, which will begin in the second quarter of this year, will be a double blinded, placebo-controlled, phase I/II trial investigating the safety and potential efficacy of Zofin™ for patients suffering with knee osteoarthritis.
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, chemokines, and 102 unique microRNAs as well as other exosomes/nanoparticles derived from perinatal tissues.
According to the Centers for Disease Control and Prevention, osteoarthritis (OA) is the most common form of arthritis and affects over 32 million adults in the US. It occurs most frequently in the hands, hips, and knees, where the cartilage within the joints begin to break down and the underlying bones begin to change. It is a chronic disease, and these changes usually develop slowly and get worse over time. OA can cause pain, stiffness, and swelling, and in some cases, causes reduced function and disability; some people are no longer able to do daily tasks or work.
“Osteoarthritis is a very common, degenerative disease with no cure or long-term treatment strategy,” said Dr. Mari Mitrani, Chief Science Officer of Organicell. “We are excited to initiate this FDA approved clinical trial and to further explore the potential of Zofin™ in battling this disease.”
Source – BusinessWire