CLEVELAND, Sept. 20, 2011 /PRNewswire/ — TheraVasc (www.theravasc.com) announced the successful completion of a Phase I clinical trial of a drug, TV1001, to diabetic patients. The trial included 12 diabetic patients who each received a single dose of two different oral formulations of TV1001, an enteric coated and a non-enteric coated capsule, to determine safety and blood levels of the drug. Based on prior studies conducted in animals, the circulating blood levels in all patients were in the range believed to be therapeutic.
“Many of the patients treated in this study have severe chronic wounds for which no effective treatments are available. Based on the safety of the drug we observed in this study and the ability to achieve a therapeutic benefit in animals at the dose tested in this study, this drug offers hope that someday we might have a way of effectively treating these diabetic ulcers,” said Dr. Frank Greenway, the Principal Investigator of the Study and Director of the Outpatient Clinic at the Pennington Biomedical Research Center.
Few adverse events were reported during the trials and there was no significant increase in methemoglobin levels, which would have prevented the release of oxygen in the blood, at the dose tested, the most likely adverse event associated with the treatment.
TheraVasc’s previously conducted animal studies using TV1001 showed that when taken chronically, similar blood levels resulted in the generation of new blood vessels in oxygen-deprived limbs, improvement in wound healing, and inhibition of tissue necrosis. The company expects to complete Phase IIa trials in mid-2012 in which the safety of multiple doses of chronically administered TV1001 will be assessed, along with testing for evidence of biological activity.
TheraVasc is initially developing TV1001 as a treatment for diabetic patients with Peripheral Arterial Disease (PAD), a condition affecting 14 million people in the United States leading to significant pain in the limbs that can ultimately result in amputation. “Based on the safety, circulating half life levels of the drug and blood levels achieved in this study, we believe that chronic use of TV1001 will provide a disease altering benefit to diabetic patients with PAD,” said TheraVasc President and CEO, Tony Giordano, Ph.D.
TheraVasc Inc., located in Cleveland, Ohio is dedicated to reducing the risk, cost, and time associated with drug development by focusing on developing repurposed drugs for unserved vascular disease markets. TheraVasc’s initial product, TV1001 (an oral formulation of sodium nitrite) targets patient populations with poor blood flow to the extremities, such as those with diabetic leg and foot problems or those with peripheral artery disease.