phase three green light

Avexa (ASX:AVX) announced at its Annual General Meeting (AGM) today that it has received positive
feedback from both North American and European regulatory authorities allowing immediate progression
into a Phase III program for apricitabine (ATC), an NRTi the company is developing for the treatment of
drug-resistant HIV patients.
At the AGM the company stated that it will move forward with two pivotal clinical trials which have been
reviewed and will form the basis for future approval. The end point of the trials will be the percentage of
patients that reach less than 400 copies of the virus per millilitre of blood after 24 weeks. The start dates of
the trials will be staggered as the company is required to assess two dose levels in the first trial to confirm
the optimum dose. The second trial will study the optimum dose only. The patient population and clinical
end points will be very similar to those of the current Phase IIb 24 week timepoint, the results of which were
announced in September of this year. Those results showed that apricitabine was superior to lamivudine,
was very well tolerated and increased patients’ CD4 cell levels. Avexa further advised that there are now
37 patients on the Phase IIb extension study, with some patients having been treated with ATC for over 2
years.
“This is an extremely exciting time for Avexa� stated CEO Dr Julian Chick. “We have plenty of work ahead
of us but we have a clear path forward towards approval and subsequent marketing of ATC. Furthermore,
we are encouraged by the very positive results from the 24 week study, which have direct relevance to the
planned phase III studies. In addition, the number of patients requesting to continue ATC treatment gives
us further confidence that ATC is providing patients with an effective new treatment in the fight against HIV
and making a significant difference to their lives.�
Avexa expects to initiate the Phase III program next month. The company stated that it will seek a partner
to assist in the completion of the Phase III program and prepare the product for filing and launch. The
company will also seek partners for possible combination products for ATC.
During the AGM Dr Chick also announced that Avexa’s antibacterial program for the treatment of MRSA
infections (“superbugs�) and its HIV integrase inhibitor program have both entered into formal preclinical
studies with a goal of entering Phase I studies (IND filing) in 12 months.
“This is an extremely positive advance for these earlier stage programs� stated Dr Chick “and it
demonstrates the growing value of Avexa’s product pipeline.�