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www.fdanews.com/articles/91489-toyama-starts-u-s-trials-of-polymerase-inhibitor

TOYAMA STARTS U.S. TRIALS OF POLYMERASE INHIBITOR

March 13, 2007

Toyama Chemical announced it has launched Phase I clinical trials of T-705, its novel anti-influenza compound, in the U.S.

T-705 is a unique viral RNA polymerase inhibitor that acts on viral genetic copying to prevent its reproduction. Previous studies carried out in cooperation with the National Institute of Allergy and Infectious Diseases demonstrated that T-705 has exceptionally potent activity in mouse infection models of H5N1 avian influenza. Toyama Chemical is currently developing T-705 as a treatment for influenza infections including infections with H5N1 strains.

Currently, the main antiviral agents approved to treat influenza infection are neuraminidase inhibitors, according to Toyama. In many countries neuraminidase inhibitors are being stockpiled amid mounting fears of a worldwide pandemic of H5N1. T-705, which has a different mechanism of action, would provide physicians and patients with alternative treatment options to the current therapies.

In the U.S., Toyama has held meetings with HHS and the NIH to discuss the development of T-705. In Japan, Phase I clinical trials started at the end of January, and administration of the maximum dose was completed in the beginning of March. Development of T-705 in Japan and the U.S. will be carried out in parallel.