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KORONIS BEGINS TRIAL OF ANTIVIRAL HIV/AIDS THERAPEUTIC

October 12, 2005

Koronis Pharmaceuticals has begun a Phase Ib clinical trial of KP-1461, its novel antiviral therapeutic, in HIV-positive patients. The objectives of the trial are to evaluate the safety, toxicity, pharmacokinetic profile and initial clinical activity of KP-1461. The trial is being conducted at several HIV treatment centers in the U.S.

KP-1461 is a first-in-class therapeutic designed to overcome the problem of drug resistance that has emerged with approved HIV treatments. KP-1461 has a novel mechanism of action designed to eliminate HIV by selectively increasing its natural mutation rate to a point that it can no longer replicate. Unlike currently approved HIV treatments — enzyme and fusion inhibitors — that work to block virus activation and replication, KP-1461 targets HIV mutation to force the production of a nonfunctional virus.

The multicenter, randomized, double-blind, placebo-controlled, dose-escalation study is currently open to enroll approximately 40 HIV-positive patients who have previously failed highly active antiretroviral regimens.