Developing treatments for chronic diseases
 

TheraVasc Releases Phase I Trial Data Demonstrating Safety of Drug in Diabetic Patients

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...

TheraVasc’s clinical trial of PAD drug shows safety in diabetic patients

A phase 1 trial of a peripheral artery disease drug candidate from TheraVasc demonstrated safety in diabetic patients. The positive clinical trial data reported by Cleveland-based TheraVasc potentially puts the young company one step closer to a development partnership with a big drug maker or a venture round between $10 million and $20 million. The company will likely need to achieve one of those milestones to continue funding expensive trials of the drug, known as TV1001. The single-dose, 12-patient phase 1 trial was intended to assess safety and blood levels of the drug. “Few” adverse events were reported, according to a statement from TheraVasc. The company is reformulating a drug — sodium nitrite — for the treatment of peripheral artery disease (PAD), a condition in which narrowed arteries reduce blood flow to the limbs. The condition often afflicts diabetics and can result in the amputation of patients’ feet. Advertisement TheraVasc plans to complete a phase 2a clinical trial this year. In addition to measuring the drug’s safety and tolerability, the phase 2a trial’s design calls for assessments of vascular integrity in patients, along with their walking abilities and quality of life improvements at the end of the trial period. Animal studies have shown the drug to lead to the generation of new blood vessels in oxygen-deprived limbs, improvement in wound healing and inhibition of tissue necrosis, according to the statement. “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,” CEO Tony Giordano said. TheraVasc...
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