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Thursday May 11, 2:00 am Eastern Time
Company Press Release
SOURCE: Novirio Pharmaceuticals, Inc.
Novirio Awarded $1.1 Million Grant by the National
Institutes of Health To Develop New Class of Hepatitis
B Drug Compounds
CAMBRIDGE, Mass., May 11 /PRNewswire/ -- Novirio Pharmaceuticals, Inc. today announced the award of up to $1.1
million from the ``Fast-Track'' Small Business Innovative Research (SBIR) program which is sponsored by the National
Institute of Allergy and Infectious Diseases, a division of the National Institutes of Health (NIH). Novirio will use this funding to
further the development of its novel class of hepatitis B compounds.
The NIH's Fast-Track program is designed to expedite the award of SBIR phase II funding for projects demonstrating the
potential to address significant medical need which have a high likelihood for commercial success. In 1999, less than
two-percent of all SBIR grant applications were awarded through the Fast-Track program.
Chronic hepatitis B infection, which may lead to cirrhosis, liver cancer and liver failure, affects an estimated 350 million people
and is the ninth most common cause of death worldwide, according to the Centers for Disease Control and the World Health
Organization. Current treatments for hepatitis B, including interferon alfa and lamivudine, fail to provide lasting benefit for the
majority of patients who are chronically infected with the hepatitis B virus (HBV).
Novirio is developing a novel class of potent antivirals that are uniquely active against HBV. The compounds, L-dT, L-dC and
L-dA, are unmodified nucleosides that prevent the replication of viral DNA without adversely affecting host cell function. The
Company has presented positive animal model data on the pharmacology, toxicology and antiviral potency of both L-dT and
L-dC at recent scientific antiviral meetings. In woodchucks chronically infected with hepatitis virus, a widely accepted model of
human HBV infection, the administration of L-dC and L-dT for 28 days produced a potent, dose-related inhibition of viral
replication at all doses tested without any detectable drug related toxicity. Based on studies measuring the oral bioavailability of
L-dT and L-dC and the extended persistence of the active metabolites in infected human liver cells, the Company anticipates
that a convenient dosing formulation and schedule will be likely.
``Funding from the grant awarded to Novirio will be applied to the development of three clinical candidates, L-dT, L-dC and
L-dA, of which L-dT and L-dC are the most advanced,'' commented Martin L. Bryant, M.D., Ph.D., Executive Vice
President, Research and Development for Novirio. ``Each of these compounds has demonstrated significant inhibition of HBV
replication without toxicity in animal models, and the receipt of this Fast-Track award from the NIH will accelerate the
evaluation of these compounds.''
``We are working diligently with the U.S. F.D.A. and other regulatory agencies to implement a development program that will
enable the rapid initiation of pivotal efficacy studies,'' said Maureen W. Myers, Ph.D., Vice President, Medical Affairs for
Novirio.
Novirio Pharmaceuticals, Inc., based in Cambridge, Massachusetts, together with its affiliates, is a biopharmaceutical company
focusing on the discovery, development and commercialization of therapeutics for the treatment of life-threatening human viral
diseases. The Company's principal disease targets are viral hepatitis and HIV/AIDS.
Contact: David Franklin, Director, Marketing and Corporate Communications of Novirio Pharmaceuticals, Inc.,
617-250-3116; or Joy Bessenger, investor, ext. 265, or Tony Ho Loke, media, ext. 213, both of Noonan/Russo
Communications, Inc., 212-696-4455, for Novirio Pharmaceuticals, Inc.
SOURCE: Novirio Pharmaceuticals, Inc. |
