TheraVasc has successfully completed 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.
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.