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New Analysis Shows Novel Nucleoside Analog KP-1461 Demonstrates Clinical Activity against HIV

KP-1461 is an investigational nucleoside analog that works differently than approved nucleoside/nucleotide reverse transcriptase inhibitors. With its unique mechanism of action, the agent accelerates HIV mutation to such an extent that the virus is disabled -- a phenomenon known as "terminal mutagenesis" or "error catastrophe."

Preliminary studies indicated that KP-1461 had potent activity against HIV. But a repeat of serial passage laboratory studies failed to reproduce such activity, and in 2008, clinical trials of the drug were halted.

Now, Koronis Pharmaceuticals, the company developing KP-1461, has announced that a comprehensive review has confirmed that the drug has anti-activity in the laboratory and in the body, as suggested in the earlier studies.

Reprinted below is a Koronis press release describing the new findings.

Koronis Pharmaceuticals' Scientific Advisory Board Confirms KP-1461 Clinical Drug Activity, HIV Ablation

Seattle, WA -- May 19, 2009 -- Koronis Pharmaceuticals, Inc., a biotechnology company focused on the development of antiviral therapeutics, today announced that its Scientific Advisory Board (SAB) completed a comprehensive review of the current in vitro and in vivo data for its lead HIV drug, KP-1461. The SAB concluded that recently completed in vitro serial passage studies corroborated the original published data, demonstrating that KP-1212, the active form of the oral prodrug KP-1461, ablated HIV in equivalent laboratory experiments. Additional studies are underway to assess ablation with greater sensitivity.

The SAB also reviewed statistical analyses of in vivo data from clinical trials of KP-1461. They concluded that KP-1461 demonstrated a statistically significant decrease in HIV RNA at the highest dose level as compared to placebo in the Phase 1b study. Decreases in HIV RNA were seen in some patients in Koronis' Phase 2a study, though the results were not statistically significant. Each clinical study met its primary endpoint of demonstrating that KP-1461 was generally safe and well tolerated.

"The current data confirms that the drug results in a substantial loss of HIV in tissue culture, demonstrates antiviral activity in HIV-positive patients and supports the continued development of KP-1461 and Viral Decay Acceleration," stated James Mullins, PhD, Professor of Microbiology and Medicine at University of Washington and Koronis SAB Chair.

According to Dr. Mullins, "Koronis has shown that in a repeat of previous work KP-1461 reduces HIV titer to below detectable levels without noting the drug resistance that is seen with currently approved HIV drugs. This demonstration of the VDA mechanism, if confirmed by further clinical studies, will dramatically alter the treatment paradigm for HIV patients."

Koronis is in the process of completing formulation refinement and designing the next clinical studies of KP-1461.

About Koronis

Koronis Pharmaceuticals, Inc. is a privately held biotechnology company developing anti-viral therapeutics based on a novel mechanism, Viral Decay Acceleration (VDA). The company's lead product candidate is KP-1461 for the treatment of human immunodeficiency virus (HIV). The company also has products in development for the treatment of hepatitis C and RSV. For more information on Koronis, please visit www.koronispharma.com.

5/22/09

Source

Koronis Pharmaceuticals. Koronis Pharmaceuticals' Scientific Advisory Board Confirms KP-1461 Clinical Drug Activity, HIV Ablation. Press release. May 19, 2009.