interesting update on ATCAvexa?s portfolio at 31 December 2010...

interesting update on ATC

Avexa?s portfolio at 31 December 2010 comprised the following projects.

Apricitabine (ATC)
The data analysis of the first part of the global phase 2b/3 clinical trial of ATC was completed. This showed that
the 800mg ATC dose was the optimum dose. ATC also showed good efficacy and safety when used in
combination with the newer drugs which have recently been approved. These results enable the design of a
further study to confirm ATC?s activity in this setting, which mirrors the expected clinical use of ATC. The
number of people successfully treated with ATC for at least 24 weeks was increased more than four times,
which expands the knowledge of the safety and tolerability of ATC.

The primary focus of the program over the
last 6 months has been to design a new clinical trial paradigm for discussion with the FDA in early 2011.

There remains an unmet medical need for HIV drugs targeting resistance.

ATC is such a program and has many positive attributes including:
? Safety: ATC has a very clean safety profile in all clinical studies to date.
? Anti-HIV advantage: ATC targets both wild-type and drug-resistant HIV virus. This has been clearly
demonstrated in the Phase IIa and IIb clinical trials.
? Specificity: It is HIV specific, i.e. it has no activity against other non-retroviruses and so would
compliment anti-HBV or HCV agents in co-infected patients.
? High genetic barrier: ATC has a strong resistance profile, with no ATC-resistance seen to date in any
study, including dosing patients over a 96 week period.
? Dosing: It is currently 800mg, B.I.D. but the 600mg and 800mg showed no difference in activity over a
24 week dosing period, therefore suggesting potential for a lower dose if required for a fixed dose
combination product.
? CD4 cell benefit: ATC increased the CD4 cell counts of treated patients above that seen with patients
treated with optimized background containing 3TC.
? Disease progression: ATC appears to slow the disease progression of HIV in patients over the
standard of care as well as decreasing the rate of re-optimizations for patients suggesting that ATC has
a 'protective' profile for other HIV drugs with less robust resistance profiles in a multi-drug treatment
regimen.
? A strong patent portfolio covering the product, method of use and manufacturing until 2027.


just as it was buried in the half-yearly