Avexa asked to reconsiderPosted 28 June 2010Two international...

Avexa asked to reconsider

Posted 28 June 2010

Two international AIDS treatment advocacy groups have appealed to biotechnology company Avexa to reconsider a decision to halt development of HIV treatment apricitabine (ACT).

In an open letter to the company, the AIDS Treatment Activists Coalition based in New York and European AIDS Treatment Group based in Brussels, said they believed ACT was a potentially important drug. They described it as "one of the few products currently in the pipeline that could help patients with multidrug resistance tip the balance in favour of viral suppression, health and, for many, life itself".

In early May, Avexa announced it was cancelling its ACT program after failing to secure a global pharmaceutical company as a partner. CEO Julian Chick also stepped down and as a result Avexa''s share price fell 77.5% from 9.3 cents to 2.7 cents. The share price remains low at 3 cents.

ATC is in the nucleoside reverse transcriptase inhibitor class (NRTI). A Phase III clinical trial of the drug closed last October. When it cancelled the program, the company said the clinical milestone timelines for ATC were consistently achieved and the trial results were excellent in terms of safety and efficacy.

The letter went on to say doctors and a growing number of patients with limited treatment options had been counting on approval of ATC to enable the construction of effective medication regimens. "Apricitabine can mean the tipping point between success and failure of a salvage regimen -- between life and death," they wrote. They added the nucleoside analog had shown good efficacy in patients with the most common nucleoside mutation, M184V.

ACT stood out among other drugs in development as "a member of a well-understood class, the one nearest to approval, and as an agent addressing one of the most common forms of drug resistance", they argued. Furthermore, according to the groups, the FDA has said it recognises the need for new salvage therapies and appears to be willing to work with companies to bring new products to the market despite the difficult environment. "The tide is turning. This is not the time to abandon apricitabine. We ask that Avexa reconsider its decision not only based on potential sales but also on the survival of patients at risk," they concluded.

http://www.trialsinfocus.com/

Trials in Focus is an independent clinical trials industry news service for Australia and the Asia Pacific. To find out more, go to www.trialsinfocus.com