Toyama Chemical Submits IND for Its Anti-Influenza Compound ''T-705''
Toyama Chemical Co., Ltd., (TOKYO:4518) (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 by providing new medicines for unmet medical needs."
Reference: WHO
http://www.who.int/csr/disease/influenza/pandemic/en/