TV1001SR history and its potential
Prior to JanOne acquiring the TV1001SR license, the company’s Chief Scientific Officer, Tony Giordano, PhD working closely with Amol Soin, MD, JanOne’s Chief Medical Officer, led early Phase 1 and Phase 2a clinical studies for the drug. Those study results showed significant promise for treating PAD and, while not the intent of the studies, there was data to support the future potential to treat Diabetic Neuropathy. The drug also seemed to have notable pain relieving qualities that has spurred additional early stage research for the potential development of a non-addictive pain medication.
Phase 2a study results
The Phase 2a study was a double blind clinical trial across ten sites throughout the United States for an investigational drug to treat Peripheral Artery Disease (PAD). As sodium nitrite has been demonstrated to promote new blood vessel growth, speed up wound healing and prevent tissue necrosis in animals, it was a primary component in the PAD treatment formulation to address the symptoms and downstream implications suffered by PAD patients.
In addition to meeting its safety end-points, the study sought to determine whether the drug, when given orally, could provide the same benefits to patients with PAD as it did in animal studies. Following ten weeks of twice daily administration, it proved to be well tolerated by patients with significant improvement in endothelial function and a significant reduction in PAD associated pain, especially for those with diabetes. The primary adverse events were headaches and dizziness, which resolved without intervention.
To overcome these side effects, the company developed a sustained release formulation of the drug (TV1001SR). This product was evaluated in a small Phase 2a study of patients with Diabetic Neuropathy. There were no treatment related reports of headaches nor were there any differences between treatment and placebo groups in reports of dizziness. The study also reported a positive trend towards pain reduction and a significant improvement in nerve function.