CLEVELAND, Aug. 2, 2016 /PRNewswire/ -- TheraVasc Inc., headquartered in Cleveland, Ohio, has announced the successful completion of a Phase II clinical study on patients with diabetic neuropathy pain. The double blind, randomized and placebo controlled trial was just completed in Southwestern Ohio using a new sustained release formulation of TheraVasc's pain medication, known as TV1001sr.
In a previous Phase II study, the immediate release version of the medication, known simply as TV1001, improved vascular health while significantly reducing pain in diabetic patients with peripheral arterial disease. TV1001 was also shown to be very safe, with the exception of some complaints of headaches. The sustained release version of the medication received no such complaints.
"Our patients did very well. We noticed statistically significant improvements in the neuropathic pain symptom inventory, which is a standard screening tool for the severity of diabetic neuropathy pain," said Dr. Amol Soin, a Cleveland Clinic trained pain management physician who helped carry out the study. "Patients also noted a decrease in overall and continuous pain scores by as much as 50 percent. Pain reduction of this magnitude in patients with diabetic neuropathy is quite significant and better than a lot of current treatments. Plus, this drug has a completely novel mechanism of action and actually treats the cause of the pain instead of masking symptoms."
"We are very pleased to see that TV1001sr completely eliminated the headaches associated with the immediate release formulation and extremely excited to see that our second Phase II study once again demonstrated strong and consistent clinical results in the reduction of pain," added TheraVasc founder and CEO Dr. Tony Giordano. "In addition to diabetic neuropathy, we believe that there are many other conditions associated with chronic pain that could be treated with TV1001sr."
Over 300 million people worldwide suffer from diabetes—a number that is expected to grow by over 50 percent by 2035. TheraVasc's medication uses sodium nitrite to treat diabetic pain by stimulating blood vessels. The medication is also non-addictive and non-sedating. This is an important feature considering that prescription drug abuse/overdose now accounts for one of the leading causes of preventable death in our country.
Recently, the company has recruited several key leaders in the field of pain management including Dr. Nagy Mekhail, former director of pain management at the Cleveland Clinic, and Dr. Edgar Ross, the clinical director of pain management at Harvard Medical School's Brigham and Women's Hospital.
"A non-addicting, non-sedating medication that actually treats the mechanism of diabetic neuropathy pain would be quite helpful in clinical practice," said Ross upon hearing the news of TheraVasc's latest successful study. "A non-addicting solution would be a tremendous breakthrough in treating chronic pain."
TheraVasc, Inc. is a privately held, Ohio-based pharmaceutical company, which is developing a new therapy to treat chronic pain conditions, such as diabetic neuropathy. For more information, visit www.theravasc.com.
TV1001sr is a non-narcotic repurposed drug with an excellent safety profile that has been shown to stimulate new blood vessel formation and inhibit inflammation in multiple animal models of ischemia.
In two independent clinical trials completed by TheraVasc, patients with chronic pain due to either peripheral arterial disease or diabetic neuropathy reported significantly less pain—at 10 weeks and 13 weeks—after being treated with TV1001 or TV1001sr.
Because of its mechanism of action, TheraVasc's Clinical Advisory Board believes TV1001sr will ultimately provide benefit to patients with chronic pain resulting from a number of conditions associated with microvascular disease. The company has future plans to conduct Phase III clinical studies in patients with systemic sclerosis, an autoimmune disease associated with microvascular damage in the hands, leading to severe pain and ulcers.
SOURCE TheraVasc Inc.