Vertex Pharmaceuticals (NASDAQ:VRTX)
Historical Stock Chart
From Aug 2019 to Aug 2024
![Click Here for more Vertex Pharmaceuticals Charts. Click Here for more Vertex Pharmaceuticals Charts.](/p.php?pid=staticchart&s=N%5EVRTX&p=8&t=15)
Research Findings Suggest Potent Antiviral Activity and Favorable In Vitro
Resistance Profile for Vertex's Investigational HCV Protease Inhibitor VX-950
BOSTON, Oct. 27 /PRNewswire-FirstCall/ -- The investigational hepatitis C viral
(HCV) protease inhibitor VX-950 exhibits potent and sustained antiviral activity
in vitro and has favorable pharmacokinetic properties, according to preclinical
results presented by scientists from Vertex Pharmaceuticals at the Annual
Meeting of the American Association for the Study of Liver Disease (AASLD) held
this week in Boston. In addition, researchers reported that VX-950 retains full
in vitro potency against HCV replicon strains resistant to another
investigational HCV protease inhibitor currently being developed by another
company. Vertex plans to initiate clinical studies of VX-950 in early 2004.
"As we prepare to advance VX-950 into initial clinical evaluation, these
preclinical results provide important information that is in line with the
treatment goal for this disease: clearing the hepatitis C virus from the
liver," said John Alam, M.D., Senior Vice President, Drug Evaluation and
Approval of Vertex. "Although significant progress has been made in recent
years with combination therapy regimens, nearly half of HCV patients currently
treated with the standard of care, pegylated interferon plus ribavirin, fail to
achieve a sustained response. Direct antivirals represent the potential for a
dramatic breakthrough in the treatment of HCV. HCV protease inhibitors, such as
VX-950, could usher in a significant treatment advance for patients with HCV."
In a conference presentation entitled "VX-950: A Tight-Binding HCV Protease
Inhibitor with a Superior Sustained Inhibitory Response in HCV Replicon Cells,"
virologist Ann Kwong, Ph.D., Head of Cell Biology and Infectious Disease at
Vertex, reported the first data using an innovative adaptation of the HCV
replicon assay commonly utilized to measure the potency of antiviral compounds
against HCV. Vertex scientists used the HCV replicon assay system to evaluate
how HCV protease inhibitors sustain potency over a period of four weeks. In
these experiments, HCV replicon cells, which mimic the intracellular replication
of HCV, were treated with VX-950 and were evaluated at multiple time points. In
one experiment, treatment with VX-950 for nine days reduced HCV RNA by almost
10,000-fold (4 log10). In another experiment, HCV replicon cells treated with
VX-950 for thirteen days exhibited viral clearance at day thirteen, and no
rebound of HCV viral RNA was observed at day twenty-seven.
Dr. Kwong also described the development of a novel preclinical HCV protease
expression model that was designed to stringently evaluate the ability of small
molecule compounds to inhibit HCV protease in liver tissue. VX-950 dosed orally
resulted in a significant, dose-dependent inhibition of an HCV-protease
enzyme-dependent signal. In untreated control models, high concentrations of
active HCV protease enzyme over seven days were associated with significant
liver damage. However, treatment with VX-950 for the initial three days of the
experiment resulted in sharply reduced liver damage. These data are the first
to suggest that an HCV protease inhibitor may have a tissue-sparing effect on
the liver. The mechanism by which this occurs is currently under
investigation.
Additional data presented at the meeting by Vertex researchers demonstrated that
the viral resistance profile of VX-950 is different from the resistance profile
of the HCV protease inhibitor BILN-2061 in HCV replicon cells. VX-950 was able
to inhibit HCV replicons containing the dominant mutation observed for BILN-2061
to the same degree as inhibition of wild type replicons. BILN-2061 is an
investigational HCV protease inhibitor currently being developed by another
company.
VX-950 is an oral, small molecule protease inhibitor discovered by Vertex using
structure-based drug design. Vertex was the first to solve the structure of the
hepatitis C NS3-4A protease domain, an enzyme that is essential for HCV viral
replication. In addition to potent activity observed in vitro, preclinical
testing conducted to date shows that VX-950 achieves excellent exposure in the
liver, the target organ for HCV treatment, good oral bioavailability and
favorable pharmacokinetic properties.
Chronic hepatitis C infection afflicts approximately 2.7 million people in the
U.S., many of whom are unaware of the infection, which is often undetected for
up to 20 years following initial infection. Worldwide, the disease strikes as
many as 185 million people. HCV causes inflammation of the liver, which may
lead to fibrosis and cirrhosis, liver cancer, and ultimately, liver failure.
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 Vertex Pharmaceuticals
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 partners. Vertex's
product pipeline is principally focused on viral diseases, inflammation,
autoimmune diseases and cancer. Vertex co-promotes the new HIV protease
inhibitor Lexiva(TM) with GlaxoSmithKline.
Vertex Pharmaceuticals' Safe Harbor Statement
This press release may contain forward-looking statements, including statements
that Vertex plans to initiate clinical studies of VX-950 in the stated
timeframe. 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 risk that i) VX-950
preclinical data may not be indicative of any future results; ii) Vertex's drug
development programs may not proceed as planned due to partnership, technical or
patient enrollment issues, and other risks listed under Risk Factors in Vertex's
form 10-K filed with the Securities and Exchange Commission on March 31, 2003.
Lexiva(TM) is a registered trademark of the GlaxoSmithKline group of companies.
Vertex's press releases are available at http://www.vrtx.com/.
References:
"VX-950: A Tight-Binding HCV Protease Inhibitor with a Superior Sustained
Inhibitory Response in HCV Replicon Cells," Kwong, et al, Presentation,
Hepatitis C: Therapy I Parallel Session, AASLD 2003
"VX-950, A HCV Protease Inhibitor, Retains Potency Against BILN-2061
Resistant Replicon Cells," Lin et al, Poster #1000, AASLD 2003
"VX-950: The Discovery of an Inhibitor of the Hepatitis C NS3-4A Protease
and a Potential Hepatitis C Virus Therapeutic," Perni et al, Poster #972,
AASLD 2003
Vertex Contacts:
Lynne H. Brum, Vice President, Corporate Development and Communications,
617-444-6614
Michael Partridge, Director, Corporate Communications, 617-444-6108
Michele Karpf Belansky, Associate Director, Corporate Brand Management,
On-site at conference: 617-510-5805, office: 617-444-6259
http://www.newscom.com/cgi-bin/prnh/20000119/VERTEXLOGO
http://www.newscom.com/cgi-bin/prnh/20000502/BOGER
http://photoarchive.ap.org/
DATASOURCE: Vertex Pharmaceuticals
CONTACT: Lynne H. Brum, Vice President, Corporate Development and
Communications, +1-617-444-6614, or Michael Partridge, Director, Corporate
Communications, +1-617-444-6108, or Michele Karpf Belansky, Associate
Director, Corporate Brand Management, On-site at conference: +1-617-510-5805,
office: 617-444-6259, all of Vertex Pharmaceuticals
Web site: http://www.vrtx.com/
Company News On-Call: http://www.prnewswire.com/comp/938395.html