New HIV maturation candidates in Phase II clinical trial

Panacos Pharmaceuticals has initiated a Phase IIa clinical trial of PA-457, the first in a new class of HIV drug candidates called Maturation Inhibitors. Institutional Review Board (IRB) and other approvals have been received and the study is now open for enrolment. Panacos plans to complete dosing of all patients during the first quarter of 2005.

The study is designed to demonstrate the antiviral potency of PA-457 following once-daily oral dosing for 10 days in HIV-infected patients who are not on other antiretroviral therapy.

Panacos recently announced positive results from a Phase I/II clinical trial in HIV-infected patients. Following a single oral dose of PA-457, a significant reduction in viral load from baseline, of up to approximately 0.7 log10, was seen in patients receiving the higher dose levels.

'Initiation of Phase II development of PA-457 is a major milestone for the company,' commented Dr David Martin, VP, drug development at Panacos. 'This study builds on our recent rapid progress, generating encouraging safety and pharmacokinetic data from the Phase Ib study and demonstrating a reduction in viral load following a single oral dose in HIV-infected patients in the Phase I/II study.

During the second half of 2005, Panacos intends to initiate Phase IIb studies of PA-457, designed to pave the way for pivotal Phase III studies.