IPOXYN™, a universal oxygen carrier, is an injectable Rx for prevention of necrosis and treatment of ischemic conditions which may lead to necrosis. IPOXYN™ oxygen carriers are in pre-clinical stage of drug development.
For decades, oxygen carriers have been developed for perfusion and oxygenation of ischemic tissue. None have succeeded through the FDA for human. These products were either blood-derived elements, synthetic perfluorocarbons or red blood cell modifiers. Several of the Hemoglobin-Based Oxygen Carriers (HBOC), contained nonfunctional impurities.
These products failed to secure FDA approval. Our approach to treatment of ischemic tissue and prevention of necrosis is fundamentally different. Boston Therapeutics' injectable investigative material, IPOXYN™ is a New Chemical Entity (NCE) and not considered a biologic blood substitute. IPOXYN™ is a modified heme chemical structure. Furthermore, because of IPOXYN™'s extremely small molecular size, roughly 1/5,000th the size of a red blood cell, IPOXYN™ is able to perfuse constricted, ischemic capillaries which are inaccessible to red blood cells. This small molecular size may have particular significance in treating vascular complications of diabetes since red blood cells may already be enlarged and lower limb vasculature may be compromised. Pre-clinical studies on IPOXYN™, including safety and efficacy studies, are planned and results may be available for evaluation by Q3 2018.