Results to be Presented at 41st Annual Meeting of the European Association
for the Study of the Liver
VIENNA, Austria, April 26 /PRNewswire-FirstCall/ -- 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
SOURCE Vertex Pharmaceuticals Incorporated
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Related links:
http://www.vrtx.com/
http://www.prnewswire.com/comp/938395.html /
CONTACT:
Lynne H. Brum, Vice President, Strategic
Communications, +1-617-444-6614, or Michael Partridge, Director,
Corporate Communications, +1-617-444-6108, or Lora Pike, Manager,
Investor Relations, +1-617-444-6755, or Zachry Barber, Senior
Media Relations Specialist, +1-617-444-6470, all of Vertex
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