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Toyama Chemical submits IND for its anti-influenza compound "T-705"
|January 25, 2007|
Toyama Chemical Co., Ltd., (Headquarters: Tokyo, Japan; President: Katsuhiko Nakano) submitted an IND (Investigational New Drug) application to the United States FDA (Food and Drug Administration) on January 17, 2007 for its anti-influenza virus compound “T-705”.
T-705 is a unique viral RNA polymerase inhibitor 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 Disease), and demonstrated that T-705 has exceptionally potent activity in mouse infection models of H5N1 avian influenza, a highly pathogenic infection that cannot be treated with established therapies. Toyama 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 only antiviral agents approved to treat influenza infection are neuraminidase inhibitors. However, there are concerns over the emergence of resistant virus strains to these drugs and there is no demonstrated utility for these drugs in treating H5N1 avian influenza. Under such circumstances, 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 Japan, the Phase 1 clinical studies began on January 24 under a Japanese IND. As an influenza pandemic resulting from the emergence of a ‘new’ virus is of great concern worldwide, 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 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”.
Referrence : WHO