Dr. Amol Soin Talks About Our New Treatment
TheraVasc, Inc. is a privately held, Ohio Based pharmaceutical company which is developing treatments for various chronic medical diseases using an oral formulation of sodium nitrite. Initial studies were done on patients with poor blood flow to the extremities, such as those suffering from peripheral artery disease (PAD). In the U.S., 16 – 19 million people suffer from PAD but no effective treatments are currently available. The Company’s first product is TV1001, and oral formulation of sodium nitrite to treat PAD. A recent opinion article from leading clinical experts on PAD in the premier scientific journal Nature concludes that a new finding revives “hope that a drug might one day be available.” The drug, sodium nitrite, referenced in this article has been shown to selectively stimulate the re-growth of blood vessels specifically in ischemic tissues such as those of diabetes and those afflicted with PAD. Additionally, sodium nitrite promotes wound healing and prevents tissue necrosis in diabetic animals. TheraVasc has completed a Phase I clinical study and a Phase II study of diabetic patients with PAD using TV1001. The Phase II was designed to show safety of chronic administration and to assess biological activity of some parameters associated with PAD. The study demonstrated safety as well as improvement in blood flow and pain scores in diabetic patients with PAD. After obtaining positive results in our Phase II study and learning about the potent reduction on pain, TheraVasc’s next generation product, TV1001, a sustained- released enteric coated formulation of sodium nitrite, is being studied in patients with diabetic neuropathy. Given that TV1001 is non-addicting, non-sedating, and has a new and distinct mechanism of action to treat pain, this represents a unique opportunity to help many suffering patients. With the rise of addiction and prescription drug abuse in the US- an option such as TV1001 would be a desired first line choice for neuropathic pain in diabetics. A Phase II study on TV1001 is currently underway.