Avexa completes recruitment for first component of Phase III HIV trial

The trial is ongoing with over 130 specialist HIV centers in 15 countries and results from this component of the trial are expected in the second quarter of 2009.

The company has also provided an update on the apricitabine (ATC) extension study associated with its earlier Phase IIb trial. Approximately 37 patients remain on ATC, with the longest dosed patients receiving ATC for nearly three years.

All patients in the extension study have completed at least 96 weeks of dosing, another significant milestone in the clinical development of ATC. Thus far, patients have not developed resistance to ATC and there have been no reported serious adverse events related to the drug candidate, the company said.

Julian Chick, CEO of Avexa, said: Recruitment completion of the two-dose component of the Phase III trial further de-risks the program and adds significant value to ATC on our road to commercialization of the compound.

As evidenced in our extension study, ATC has a very strong safety profile, an unusually low level of resistance development, and an excellent antiviral activity profile against difficult-to-treat, drug-resistant HIV. The length of time that some of our patients have elected to remain on ATC validates its potential to be a robust, long-term component of any HIV treatment regimen.