JanOne has announced a licensing agreement for TV1001SR, a treatment for Peripheral Artery Disease, commonly called PAD. The agreement with LSU Health Shreveport, UAB Research Foundation, and TheraVasc, gives JanOne a worldwide, exclusive license for TV1001SR along with a portfolio of 30 patents and other intellectual property relating to the sustained release of sodium nitrite.
The company anticipates TV1001SR will be a groundbreaking treatment for those with PAD, an often painful disease affecting more than 200 million people worldwide and 8.5 million in the United States. There is no known efficacious single-drug treatment for PAD available. Current treatments only mitigate the effects of PAD without treating the underlying cause – reduced ischemic tissue blood flow, which is a lack of blood flow to the extremities, and often leads to significant pain. As a result, according to a recent Stanford University study, nearly 25% of patients with PAD are at increased risk of high opioid use.
TV1001SR was developed by Dr. Christopher Kevil, Professor of Pathology, Molecular and Cellular Physiology, and Cell Biology and Anatomy at LSU Health Shreveport. In initial research studies, the drug effectively restored ischemic tissue blood flow and was effective in a wide range of pathologies involving alterations of angiogenesis - development of new blood vessels - including diabetes, wound healing and tissue necrosis. Beneficial effects included enhancing angiogenesis, endothelial cell proliferation, and arteriogenesis.
"In our Phase 2a trials, we saw encouraging results in the participants. The compound not only improved vascular function, but patients also reported a significant reduction in their PAD-associated pain," said Tony Giordano, Ph.D., former CEO of Theravasc and JanOne scientific advisory board member. "During the trial, a number of patients reported that their long-term pain had subsided, which was a positive and unexpected development."
As a result of TV1001SR's clinical trial history, JanOne will begin planning a Phase 2b clinical protocol for PAD with an expectation to commence Phase 2b trials by the second half of 2020. In addition, the company intends to apply for the secondary indication of PAD-associated pain as part of its Phase 2b trails. To streamline development and FDA approval, the company expects to pursue FDA 505(b)(2) pathway for new drug approval, due to an already approved agent associated with TV1001SR.
"Developing a non-addictive drug to treat a major disease that causes pain normally managed with opioids is exactly the kind of imaginative thinking the opioid crisis demands," said Eric Bolling, JanOne's chairman and president. "By treating PAD, the root cause of the disease, we hope to also be preventing and treating pain."
"Partnering with JanOne to bring to market this important treatment for a significant health issue is extremely gratifying," said Dr. Kevil. "We know that by treating PAD we can improve outcomes, increase quality of life, and avoid opioid addiction for potentially millions of people. I'm excited to work with JanOne and to continue the ongoing development of this critical medication."