positive reults out

Melbourne-based biotechnology company Avexa Limited (ASX:AVX) announced today positive 24 week
data from the phase 2b clinical trial of apricitabine (ATC). The data demonstrate that, in over 80% of
patients treated with ATC, the level of HIV in the blood was reduced to below detectable levels after 24
weeks. This was markedly better than those patients on the 3TC control.
“The level of response seen with ATC is remarkable for these patients, all of whom have already failed
other drug regimens. The results indicate that with ATC, even drug-resistant patients with multiple previous
treatment failures can achieve a response approaching that of previously untreated patients on first line
therapy”, said Dr Julian Chick, CEO of Avexa.
Avexa also reported that in analysing CD4 cells of patients, there were CD4 cell increases of 28 – 39% and
73 – 86% in the ATC 600mg and 800mg arms respectively, compared to the 3TC treated patients. CD4
cells are essential for a healthy immune system, and it is these cells that are primarily destroyed by HIV
infection. “This indicates that the potent suppression of HIV by ATC is benefiting the patients’ immune
system, and is an important sign of the long term clinical benefit of treatment with ATC” said Dr Chick.
Avexa reported that no virus resistant to ATC has been identified after 24 weeks of therapy, which is
consistent with the potent suppression of HIV replication and the ideal properties of a long-term anti-HIV
therapy.
The safety profile of ATC continues to be excellent. No serious adverse events related to ATC have
occurred to date and no patients have withdrawn from the trial because of any side effects related to ATC.
Furthermore, 23 patients out of an eligible 24 have entered the ATC extension study. Two patients were
ineligible for inclusion in the extension study. “The fact that such a high percentage of patients continue to
enter the extension study tells us that these patients and their clinicians believe that ATC is providing
meaningful therapeutic benefit in their treatment of the HIV disease” stated Dr Chick.
“These results clearly indicate that ATC regimens are potentially as effective, safe and durable as current
first line regimens, but for drug-resistant patients that have already failed other drug regimens. This is
excellent news for drug-resistant patients in need of potent, durable but safe new HIV therapies. These
data will be submitted for presentation at a forthcoming international HIV conference ” said Dr Chick.