CROI: Apricitabine - encouraging results

[John2038]

MELBOURNE, Australia--(BUSINESS WIRE)--Biotechnology company Avexa Limited (ASX:AVX) announced today that it will present at the 2008 BIO CEO & Investor Conference on Tuesday, February 12, 2008 at 3:30 PM EST at the Waldorf-Astoria hotel in New York.
Dr Julian Chick, CEO will provide a general update together with an overview of data from the Phase 2b clinical trial of apricitabine (ATC), the Company’s lead anti-HIV drug candidate, recently presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2008), held in Boston on February 4, 2008.

The key points from the scientific presentation are:

    * Both the 600mg and 800mg BID doses of ATC, in combination with optimized background antiretroviral therapy (ART), showed superior antiviral activity to 3TC in a population of treatment-experienced HIV-1-infected patients with the M184V mutation which included both first-line failures and patients with multiple prior treatment failures.
    * ATC given 600mg or 800mg BID was safe and very well tolerated over the 24-week study period.
    * No evidence of development of resistance to ATC was seen.
    * Larger, phase 3 trials of ATC in treatment-experienced patients are planned.

The results gathered to date clearly show that ATC:

    * Has an excellent safety profile at least equal to 3TC.
    * Is superior in antiviral activity to 3TC in failing patients with the M184V mutation.
    * Provides clear immunological benefit, increasing CD4 levels to higher levels than 3TC in failing patients with the M184V mutation.
    * Has not selected for resistant virus up to week 24.

“These results are extremely encouraging. In conjunction with the ongoing progress being made with the ATC development program, they provide clear indication of ATC's potential," said Dr Julian Chick, CEO.

Avexa anticipates releasing the 48 week data from the ATC Phase 2b trial during the current quarter. Thirty nine of an eligible forty patients remained on ATC therapy post the 48 week trial period.


Figure 1: Percentage of patients achieving target viral loads at Week 24

Figure 2. Time weighted average log10 change in HIV RNA from Day 0 to Week 24

Genotype Results

    * At Week 24, genotyping was possible for only 8 patients (2 in the 600mg ATC arm, 2 in the 800mg ATC arm and 4 in the 3TC arm) – of these 1 (600mg ATC), 1 (800mg ATC) and 4 (3TC) patients had M184V present.
    * No patients were found to have developed the L74V, K65R, Y115F, V75 mutations or additional TAMs during the 24-week period.
    * No evidence of resistance to ATC was seen.

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