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Vertex
Begins Phase II Study of VX-497 in Combination with Interferon Alpha For
Treatment of Hepatitis C Infection
CAMBRIDGE, Mass., July 3, 2000 /PRNewswire/ -- Vertex Pharmaceuticals
Incorporated (Nasdaq: VRTX) announced today that patient dosing is underway
in a Phase II clinical trial of VX-497, a novel drug for the treatment
of hepatitis C virus (HCV) infection, in combination with interferon alpha.
HCV infection is a chronic viral disease affecting 2.7 million people
in the United States. HCV causes inflammation of the
liver, which may lead to cirrhosis, liver failure, and liver cancer.
The trial announced today follows the completion of a clinical study assessing
the safety and preliminary efficacy of VX-497 as monotherapy for treatment
of HCV infection.
"In our in vitro studies against a panel of viruses closely related
to HCV, VX-497 and interferon alpha exhibited potent additive activity.
This is our first opportunity to assess the activity of VX-497 plus interferon-alpha
dosed in combination for HCV patients. Our goal is to assess whether this
combination can provide benefit to HCV patients," said Dr. Vicki
Sato, Senior Vice President of Research and Development and Chief Scientific
Officer of Vertex. "With the information we gain from this and other
clinical studies, we intend to initiate pivotal studies of VX-497 in HCV
in 2001."
Hepatitis C virus infection is recognized as a major threat to public
health. Approximately 2.7 million people in the United States are chronically
infected with the hepatitis C virus, although many are currently undiagnosed.
According to the Centers for Disease Control (CDC), hospitalization and
death rates due to HCV are projected to triple from current levels over
the next 10- 15 years.
Background on VX-497 Clinical Trials and IMPDH Mechanism of Action
The study of VX-497 in combination with interferon-alpha announced today
is a randomized, double-blind, placebo-controlled dose-escalation Phase
II trial which will enroll up to 54 adult HCV patients who have not previously
received HCV antiviral therapy. Patients will receive VX-497 plus interferon-alpha,
or placebo plus interferon-alpha, for four weeks.
The trial will assess the safety and pharmacokinetics of VX-497 when administered
in combination with interferon-alpha. The trial will also assess antiviral
activity of treatment based on changes in HCV viral RNA and changes in
levels of serum alanine aminotransferase (ALT), a marker of liver inflammation.
The objective of the study will be to compare the rate of viral decline
in patients treated with the combination of VX-497 and interferon alpha
to that in patients treated with interferon alpha alone. The trial will
be conducted at centers in the United States.
At a medical conference in late 1999, Vertex presented results from a
Phase II 28-day study of VX-497 as monotherapy in HCV patients non-responsive
to prior treatment with interferon-alpha, which suggest that the drug
was well-tolerated and resulted in reduced ALT levels.
This monotherapy study was extended for three months to further assess
the safety and pharmacokinetics of VX-497 for a longer treatment duration.
Based on clinical results and an analysis of patient need, Vertex is focusing
its resources on developing VX-497, an inhibitor of the enzyme inosine
monophosphate dehydrogenase (IMPDH), for the treatment of HCV.
The Company has also evaluated VX-497 for the treatment of psoriasis,
and results from a Phase II psoriasis trial support the therapeutic potential
of IMPDH inhibitors for treating autoimmune diseases. In early 2000, Vertex
selected a distinct IMPDH inhibitor, VX-148, as its lead drug development
candidate for the treatment of autoimmune diseases, and has
begun preclinical studies with the compound. If preclinical studies are
successful, the Company could begin clinical trials of VX-148 in 2001.
VX-497 and VX-148 are potent inhibitors of inosine monophosphate dehydrogenase
(IMPDH), a cellular enzyme that is essential for production of guanine
nucleotides, one of the building blocks of RNA and DNA.
Blocking IMPDH may be an effective strategy for blocking the
proliferation (growth) of certain cell types, such as lymphocytes, and
the replication of viruses, since both lymphocytes and viruses depend
on nucleotide synthesis for replication.
Vertex Pharmaceuticals Incorporated discovers, develops and markets small
molecule drugs that address major unmet medical needs. The Company has
eight drug candidates in clinical development to treat viral diseases,
inflammation, cancer, autoimmune diseases and neurological disorders.
Vertex has created its pipeline using a proprietary approach,
information-based drug design, that integrates multiple technologies in
biology, chemistry and biophysics aimed at increasing the speed and success
rate of drug discovery. Vertex's first approved product is Agenerase(TM)
(amprenavir), an HIV protease inhibitor, which Vertex co-promotes with
Glaxo Wellcome.
There can be no assurance that clinical trials of VX-497 will
continue, that initial VX-497 clinical trial results will be predictive
of any future results, that VX-497 will be the subject of filings for
regulatory approval, that VX-497 will receive marketing approval from
the U.S. Food and Drug Administration or equivalent regulatory authorities,
or that VX-497 will be marketed successfully. There can be no assurance
that preclinical trials of VX-148 will continue, or that Vertex will initiate
clinical studies of VX-148. Investors are also directed to consider other
risks and uncertainties discussed in Vertex documents filed with the Securities
and Exchange Commission.
Vertex's press releases are also available at www.vpharm.com
or by fax-on-demand at (800) 758-5804 - Code: 938395
SOURCE Vertex Pharmaceuticals Incorporated
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