PROJECT INFORM IN OTHER MEDIA ... 2008

Promising new drug suffers major setback

Positive Aware

by Test Positive Aware Network, May/June 2008

(mention of Project Inform in bold below)

The only ongoing study of novel anti-HIV agent KP-1461 was recently halted by its developer, Koronis Pharmaceuticals, when it failed to demonstrate measurable activity against the virus.

Through a process known as terminal mutagenesis, this experimental agent was expected to become the first HIV drug to work by speeding up the mutation rate of HIV, mutating it so severely that it becomes unable to infect cells and replicate. Laboratory experiments, in fact, showed that the virus eventually mutated itself out of existence when exposed to KP-1461.

A series of lab tests required by the U.S. Food and Drug Administration (FDA), however, showed that the drug failed to force resistance in the virus, a finding that is in direct conflict with initial results observed in similar tests conducted by the developer.

Only two people were actually taking the drug at the time of this discovery, both of which have been informed of the findings, discontinued use of the drug, and recommended to start on a full HIV regimen.

In a statement to Project Inform, Koronis lead investigator Stephen Becker, MD said that the company is “committed to understanding these discordant results and will attempt to validate the original 2002 research.” It is expected to take at least a couple of months to investigate this setback, according to Becker.