phase 3, page-7

Hi Ladies and Gents

Just in case you are sitting there getting bored have absolutely nothing better to do here is something to read ;)


Stock (ticker): Avexa (AVX.AX)
Market Cap: A$215m
Recommendation: Buy
Share price: A$0.53
Price target: A$1.39
Up/(down) to target: 162%
Fair value: A$1.39 (DCF methodology)

Subject: Starts Phase 3 clinical trial for lead anti-HIV drug

Analyst: Scott Power (+61 7 3334 4884) / Tanya Solomon (+61 7 3334 4521)

Key points:

* AVX has announced that it has initiated the Phase 3 clinical trial program for its lead drug, apricitabine (ATC), an anti-HIV drug.

* To recap on the trial design - the Phase 3 trials will compare ATC to the current standard of care in HIV-infected patients who are resistant to current drugs. It will consist of two clinical trials of 900 patients each (up from our initial expectation of 600 patients each):

* First trial - Two possible doses (800 mg or 1,200mg twice daily) of ATC initially, with the higher dose dropped at week 16, in order to confirm the optimal dose.
* Second trial - Single dose of ATC (800mg twice daily). This trial will commence when 16-week data from the first trial is released.

* The primary end point will be set at 24 weeks, and is the % of patients with less than 400 copies of the virus per millilitre of blood after 24 weeks, the same end point achieved by AVX at the 24-week point of the Phase 2b clinical trial.

* The trials will be conducted in North & South America, Europe, Africa and Asia (including Australia).

* In other news, AVX has also completed the 48 week dosing period of its Phase 2b clinical trial study. The final results of this are expected in 1QCY08, in-line with our expectations.