another article....wonder why the CFO is the one quoted?
vexa cleared to continue Phase 3
Nick Evans
Thursday, 4 June 2009
AVEXA announced its Data Safety Monitoring Board (DSMB) has cleared the continuation of its Phase 3 trial of HIV drug apricitabine (ATC), after reviewing the 16-week data from the trial.
The trial had been running with three arms – a control arm with patients taking HIV blockbuster 3TC, and two ATC arms, using 800mg and 1200mg doses respectively.
According to the company, the DSMB has recommended the 800mg dose arm continue, with patients currently on 1200mg to continue in the trial at the 800mg dose.
Avexa chief financial officer Stephen Kerr told BTN that the DSMB’s recommendation was based on its view that 800mg is the optimum dose of ATC, not on any safety issues in the trial arm of the higher dose of the drug.
In a statement Avexa chief executive Dr Julian Chick said the company was pleased the DSMB had picked the 800mg dose to go forward, which was also the company’s preferred option.
“The 800mg dose is considerably easier to formulate into fixed-dose combinations, thus increasing the commercial potential for ATC,” he said.
“Given ATC’s excellent safety and activity profile, these results allow us to move forward with increased confidence in ATC as a treatment option for HIV patients.”
Kerr told BTN that there may also be some minor cost savings for Avexa in the lower-dose decision, but these were not expected to materially affect the total cost of the Phase 3 program.
The trial will now continue with two arms comparing the 800mg ATC dose to 3TC.
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