| |
HCV Protease Inhibitors: Vertex VX-950 clinical trial in 2003
|
| |
| |
At the large annual hepatitis/liver conference AASLD which was held in
November in Boston the first study results in HCV-infected patients using an
HCV protease inhibitor were presented by Boerhinger-Ingleheim researchers.
They reported encouraging results after patients received the protease
inhibitor BILN-2061. Here is a link to NATAP's AASLD conference reports where
you'll find 3 articles on the 2 studies conducted:
http://www.natap.org/2002/AASLD/ndxAASLD.htm
Below is a press release from Vertex Pharma where they announce that they
look forward to starting a study with their protease inhibitor in humans.
Vertex Pharmaceuticals Restructures Agreement with Eli Lilly; Vertex to Lead
Development of Novel Oral Hepatitis C Protease Inhibitor VX-950
Thursday January 2, 4:05 pm ET -- VX-950 to Enter Clinical Trials in 2003
--CAMBRIDGE, Mass., Jan. 2 /CNW/ -- Vertex Pharmaceuticals Incorporated
announced today that it has restructured its agreement
with Eli Lilly and that Vertex will lead development and commercialization of
VX-950, a novel, oral hepatitis C viral protease inhibitor. Vertex plans to
begin clinical testing of VX-950 in the second half of 2003. Preclinical
studies of VX-950, begun in early 2002, are continuing in preparation for the
commencement of Phase I clinical trials. VX-950 is a small molecule protease
inhibitor from a new class of antiviral drugs that inhibit hepatitis C NS3-4A
protease, an enzyme considered essential for HCV viral replication.
The mutual decision to restructure the agreement is a result of a
reprioritization of Eli Lilly's research portfolio and Vertex's desire to
focus on specialty pharmaceutical markets and retain greater downstream
rights to its own compounds. In order to reflect these strategic priorities,
the companies have restructured their agreement. Vertex has obtained the
worldwide rights to compounds identified during the collaboration. Eli Lilly
will retain a financial interest in VX-950 and other HCV protease compounds
through royalties on future net product sales. Financial terms were not
disclosed."Vertex is enthusiastic about the opportunity to drive forward
development and commercialization of this innovative compound. Obtaining
worldwide rights to our HCV protease inhibitor program is an important value
creation step and strengthens our antiviral and infectious disease portfolio.
Our clinical group is well-positioned to move VX-950 into the clinic and
capitalize on the value of our HCV protease inhibitor discovery program,"
said Joshua Boger, Ph.D., Chairman and CEO of Vertex."Drugs such as VX-950
could usher in a significant treatment advance and provide a medical
breakthrough for patients with HCV," said John Alam, M.D., Vertex's Senior
Vice President, Drug Evaluation and Approval. "Recent clinical data from
studies with another company's HCV protease inhibitor compound have
established initial proof-of-concept for small molecule HCV protease
inhibitors. VX-950 is a distinct compound that has shown excellent in vitro
potency, and high levels of drug were achieved in both plasma and liver in
animal studies. We look forward to initiating clinical evaluation of VX-950
and to beginning to publish key data on Vertex's HCV protease compounds in
the second half of 2003. In addition, we also anticipate that Vertex's
ongoing HCV protease inhibitor discovery program will produce an additional
drug candidate in 2003 suitable for clinical development."Background on
VX-950Vertex researchers solved the three-dimensional atomic structure of HCV
protease and reported the results in the journal Cell in 1996. In 1997,
Vertex began a collaboration with Eli Lilly that has led to the discovery of
HCV protease inhibitors, and has pioneered novel chemistry and virology-based
approaches to design potent and selective compounds that block HCV viral
replication. Vertex and Lilly employed computational and combinatorial
chemistry techniques to create novel chemical scaffolds, and Vertex developed
a proprietary cell-based assay for compound screening. VX-950 exhibits potent
antiviral activity and promising pharmacological properties in preclinical
testing. During Vertex's collaboration with Eli Lilly, Vertex has led efforts
on HCV protease inhibitor drug design, process development and pre-commercial
drug substance manufacturing work, and has taken the lead in conducting
ongoing toxicology studies. The HCV protease inhibitor field has received
renewed attention in recent months, following presentation of the first
clinical data on another company's HCV protease inhibitor compound at the
American Association for the Study of Liver Disease (AASLD) meeting in
November 2002.Background on HCV InfectionHCV infection is a serious disease
that causes inflammation of the liver, which may lead to fibrosis and
cirrhosis, liver cancer, and ultimately, liver failure. Chronic hepatitis C
infection afflicts approximately 2.7 million people in the U.S., many of whom
are unaware of their infected status. HCV may go undetected for up to 20
years following initial infection. Worldwide, the disease strikes as many as
185 million people. Each year, 8,000 to 10,000 people in the U.S. die from
complications of HCV. Current treatments have been effective for only 40 to
60 percent of chronically infected HCV patients and are associated with
significant side effects. At the present time, there are no direct antiviral
therapies available for the treatment of HCV infection.About VertexVertex
Pharmaceuticals Incorporated is a global biotechnology company. Vertex seeks
to discover, develop, and commercialize major pharmaceutical products
independently and with partners. Chemogenomics, Vertex's proprietary,
systematic, genomics-based platform, is designed to accelerate the discovery
of new drugs and to expand intellectual property coverage of drug candidate
compounds and classes of related compounds. This approach, which targets gene
families, has formed the basis for several commercial collaborations under
which Vertex retains rights to downstream revenue. Vertex's first approved
product is Agenerase(R) (amprenavir), an HIV protease inhibitor, which Vertex
co-promotes with GlaxoSmithKline. Vertex has more than 12 drug candidates in
clinical and preclinical development to treat viral diseases, inflammation,
cancer, autoimmune diseases, neurological disorders and genetic
disorders.This press release may contain "forward-looking" statements,
including statements that Vertex's HCV protease research program will produce
additional drug candidates, that Vertex anticipates initiating clinical
studies with VX- 950 in the second half of 2003, and that HCV protease
inhibitors could provide a major clinical advance in treatment of HCV. While
Vertex's management uses its best efforts to be accurate in making
forward-looking statements, those statements are subject to risks and
uncertainties that could cause actual results to vary materially. Those risks
and uncertainties include, among other things, the risk that further research
may not be successful in identifying additional drug candidates, that
preclinical studies may not lead to the initiation of Phase I clinical
trials, that clinical trials may not result in a marketable product and that
Vertex may be unable to secure regulatory approval of, or successfully
market, a drug candidate.
|
|
| |
| |
|
|
|
