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Toyama Chemical Co., Ltd. starts Phase 1 clinical trials of T-705 for its anti-influenza compound in the US
|March 12, 2007|
Toyama Chemical Co., Ltd. (Headquarters: Tokyo, Japan; President and CEO: Katsuhiko Nakano), announced that it has started Phase 1 clinical trials of T-705, its original anti-influenza virus compound, on March 9, 2007, in the US.
T-705 is a unique viral RNA polymerase inhibitor, acting on viral genetic copying to prevent its reproduction, discovered by Toyama Chemical. In 2005, Utah State University (US) carried out various studies under its contract with the NIAID (National Institute of Allergy and Infectious Diseases), and demonstrated that T-705 has exceptionally potent activity in mouse infection models of H5N1 avian influenza, a highly pathogenic infection. Toyama Chemical is currently developing T-705 as a treatment for influenza infections including infections with H5N1 strains.
The WHO (World Health Organization) has stated that in the event of a pandemic outbreak, the pandemic virus will spread rapidly, and is likely to cause high death rates.
Currently, the main antiviral agents approved to treat influenza infection are neuraminidase inhibitors. Accordingly, in many countries neuraminidase inhibitors are stockpiled as the fear of worldwide pandemic of H5N1 strains mount. However, definite therapies to treat H5N1 avian influenza are not established. Therefore, the development of T-705, which has a different mechanism of action, would provide physicians and patients with alternative treatment options to the current therapies, and would be highly beneficial.
In the US, Toyama Chemical has been holding several meetings with HHS (Department of Health and Human Services), FDA (Food and Drug Administration) and NIH (National Institutes of Health), from the beginning of last year, to discuss the development of T-705 for clinical trials. The trials began on March 9.
In Japan, Phase 1 clinical trials started at the end of January, administration of the maximum dosage was completed in the beginning of March.
Toyama Chemical considers it its social responsibility to rapidly develop T-705, and will give the project top priority. Development in Japan and the US will be carried out in parallel. Toyama Chemical will keep in close contact with regulatory agencies in both Japan and the US, and with the NIH in order to discuss and quickly resolve any issues that might arise.
Toyama Chemical specializes in research and development, and strives to “contribute to the further development of global health care through new drug development”.