Results to be Presented at 41st Annual Meeting of the European Association for
the Study of the Liver
VIENNA, Austria, April 26 /CNW/ -- Vertex Pharmaceuticals
Incorporated (Nasdaq: VRTX) today announced that researchers will present new
data supporting clinical development of VX-950, an investigational oral
hepatitis C virus (HCV) protease inhibitor being developed for the treatment
of hepatitis C, at the 41st Annual Meeting of the European Association for the
Study of the Liver (EASL) in Vienna. Two abstracts will be presented on
Thursday, April 27 based on a clinical trial originally conducted in 2005. In
the first presentation, researchers will review long-term viral sequencing
follow-up data that showed that in patients previously dosed with VX-950 as a
single agent for 14 days, a sub-optimal treatment period,
wild-type virus supplanted treatment-emergent variants and that sensitivity to
future treatment regimens that include VX-950 or other HCV protease inhibitors
may be regained. In a second presentation, researchers will describe results
of a whole genome analysis that suggests that the expression level of
interferon-sensitive genes may be restored with VX-950 treatment. An
additional late-breaker oral presentation will be delivered on Saturday, April
29. Taken together, these results strongly support further investigation of
VX-950 for the treatment of hepatitis C.
"Data from early clinical studies have consistently shown a rapid and
dramatic reduction in viral load in patients treated with VX-950, with good
tolerability," said John Alam, M.D., EVP, Medicines Development, and Chief
Medical Officer of Vertex. "We are pleased to share the results of these
extensive viral sequencing and gene expression analyses with the HCV medical
community and discuss the implications of our findings for future clinical
studies."
Viral Sequencing Analysis
In a previously presented analysis from a clinical study of VX-950 dosed
as a single agent that was completed in 2005, viral variants were detected
after 14 days of dosing with VX-950 alone. These viral variants displayed
varying degrees of sensitivity to VX-950, depending on VX-950 plasma exposure
observed during 14 days of dosing. In an oral presentation at EASL titled
"Wild-type HCV NS3 Protease Re-emerges During Follow-up After 14 days of
Dosing with VX-950 in Patients with Genotype 1 HCV," researchers describe HCV
RNA sequencing results that showed that following 14 days of dosing as a
single agent, the viral population in patients returned within three to seven
months as predominantly wild-type, the virus phenotype present before
treatment. The findings from this study suggest that viral variants
associated with decreased susceptibility to VX-950 may have reduced
replicative fitness in patients. The study further suggests that some
HCV-infected patients who have been treated with VX-950 monotherapy for 14
days, a sub-optimal treatment period, may regain sensitivity to VX-950, and
that treatment failure may not compromise future therapeutic options.
Gene Expression Analysis
In a poster presentation titled "Antiviral Activity of VX-950 Resolves
Expression of an HCV-Associated Gene Signature," Vertex researchers describe
data suggesting a normalization of gene expression in peripheral blood cells
in hepatitis C patients responding to VX-950 treatment to levels similar to
those of healthy, uninfected patients. In the gene expression analysis,
researchers identified 258 genes that are differentially expressed in the
setting of chronic HCV infection, including a large number of genes associated
with viral response, cellular defense and immune response. In patients who
achieved the greatest reduction in plasma HCV RNA following 14 days of dosing,
sustained levels of interferon-sensitive gene expression were observed in
peripheral blood cells.
Late-breaker: Phase Ib Combination Study
A late-breaker oral presentation titled "Initial Results of a 14-Day Study
of the Hepatitis C Virus Protease Inhibitor VX-950, In Combination with
Peginterferon-alfa-2a" will be presented on Saturday, April 29, by Henk W.
Reesink, M.D., Associate Professor of Medicine at Academic Medical Center in
Amsterdam. In accordance with embargo rules for the EASL conference, these
data will first be disclosed publicly in conjunction with the presentation at
5:30 p.m. Central European Summer Time (11:30 a.m. Eastern Daylight Time) on
Saturday, April 29.
About Hepatitis C
Hepatitis C is a liver disease caused by the hepatitis C virus, which is
found in the blood of people with the disease. HCV, a serious public health
concern affecting more than 3 million individuals in the United States and 170
worldwide, is spread through direct contact with the blood of infected people.
Though many people with hepatitis C may not experience symptoms, others may
have symptoms such as jaundice, abdominal pain, fatigue and fever. Hepatitis
C significantly increases a person's risk for developing long-term infection,
chronic liver disease, cirrhosis or death. The burden of liver disease
associated with HCV infection is increasing, and current therapies only
provide sustained benefit in about 50% of patients with genotype 1 HCV, the
most common strain of the virus. Novel HCV-specific compounds in clinical
development have the potential to increase the proportion of patients who can
eradicate the virus.
About VX-950
VX-950 is an investigational oral inhibitor of hepatitis C virus protease,
an enzyme essential for viral replication. In early 2006, Vertex reported
results from a 28-day, Phase II study of VX-950 dosed in combination with
peg-IFN and ribavirin. In this study, 12 of 12 patients had plasma HCV RNA
levels below the limit of detection (10 IU/mL) at 28 days. There were no
treatment discontinuations and no serious adverse events reported. In
previous studies, the most common adverse events reported in both the placebo
and VX-950 patients were headache, frequent urination and gastrointestinal
symptoms.
Vertex researchers were the first to solve the three-dimensional crystal
structure of HCV protease, and have used structural insights to enable the
design of small molecule HCV protease inhibitors, including VX-950.
About Vertex
Vertex Pharmaceuticals Incorporated is a global biotechnology company
committed to the discovery and development of breakthrough small molecule
drugs for serious diseases. The Company's strategy is to commercialize its
products both independently and in collaboration with major pharmaceutical
companies. Vertex's product pipeline is principally focused on viral
diseases, inflammation, autoimmune diseases and cancer. Vertex co-promotes
the HIV protease inhibitor, Lexiva, with GlaxoSmithKline.
Safe Harbor Statement
This press release may contain forward-looking statements, including
statements that (i) HCV-infected patients who have been treated with VX-950
monotherapy for 14 days may regain sensitivity to VX-950; and (ii) the
expression level of interferon-sensitive genes may be restored with VX-950
treatment. While management makes its best efforts to be accurate in making
forward-looking statements, such statements are subject to risks and
uncertainties that could cause Vertex's actual results to vary materially.
These risks and uncertainties include, among other things, the risks that
future studies will not confirm expectations based on the previous studies
referenced in this release, and other risks listed under Risk Factors in
Vertex's form 10-K filed with the Securities and Exchange Commission on March
16, 2006.
Vertex Contacts:
Lynne H. Brum, Vice President, Strategic Communications, (617) 444-6614
Michael Partridge, Director, Corporate Communications, (617) 444-6108
Lora Pike, Manager, Investor Relations, (617) 444-6755
Zachry Barber, Senior Media Relations Specialist, (617) 444-6470
