starting to hit news outlets. They all get the J&J deal wrong though in that is not for ATC.
thursday, June 04, 2009 Avexa's Anti HIV Drug Moves Another Step Closer To Market
Avexa Ltd (ASX: AVX) has received encouraging news regarding its anti HIV drug, apricitabine (ATC) and Phase III clinical trial.
The Data Safety Monitoring Board, a group of international experts has reviewed the 16 week data from Avexa’s apricitabine (ATC) Phase III clinical trial and recommended continuation of the study with the 800mg dose for patients and to continue their therapy.
Patients from the earlier Phase IIb study, which used the 800mg ATC dose, have been successfully treated with ATC for up to three years. In clinical trials to date, ATC has shown the following characteristics: a unique resistance profile over 96 weeks of treatment, continued efficacy beyond two years of treatment, an excellent safety profile, and an ongoing immunological benefit.
Avexa’s Phase III trial compares ATC to 3TC in drug-resistant HIV patients. The Phase III trial is being conducted with more than 130 sites worldwide. The 16 Week component had three arms comparing doses of ATC at 800mg and 1200mg to the 3TC control arm.
ATC targets a current unmet medical need that has earned the compound "Fast Track" status with the U.S. Food and Drug Administration. Dr Jonathan Coates, Avexa’s Chief Scientific Officer, is a former project leader for multiple anti-viral programs at GlaxoSmithKline and a co-inventor of anti-viral drug 3TC, one of the best selling anti-HIV drugs in history with over USD $8 billion in global sales to date.
Julian Chick, Avexa’s Chief Executive Officer said the 800mg dose is considerably easier to formulate into fixed dose combinations, thus increasing the commercial potential for ATC.
Avexa has previously entered into a six-month, worldwide exclusive option agreement with Tibotec Pharmaceuticals (a Johnson & Johnson company) for the two companies to formalise a licensing agreement.
AVX Price at posting:
13.5¢ Sentiment: Buy Disclosure: Held
