-New data show that plasma HCV RNA levels were below limit of detection (10
IU/mL) in 8 of 8 patients continued on peg-IFN+RBV for 12 weeks-
VIENNA, Austria, April 29 /PRNewswire-FirstCall/ -- Data presented at
the 41st Annual Meeting of the European Association for the Study of the
Liver (EASL) in Vienna today show that when VX-950, an investigational oral
hepatitis C virus (HCV) protease inhibitor being developed by Vertex
Pharmaceuticals Incorporated (Nasdaq: VRTX), was dosed with pegylated
interferon alfa-2a (Pegasys(R); peg-IFN), the combination was
well-tolerated and achieved a dramatic reduction in plasma viral RNA levels
in patients with chronic genotype 1 HCV infection through 14 days of
dosing. At day 14, the majority of patients (6 of 8) receiving the
combination had HCV RNA levels below the limit of quantitation (30 IU/mL,
as measured by the Roche TaqMan(R) assay), and 4 of 8 patients had HCV RNA
levels below the limit of detection (10 IU/mL, Roche TaqMan(R)). All
patients enrolled in the 14-day study subsequently received follow-on
treatment with peg-IFN and ribavirin (RBV). Researchers reported for the
first time today that 8 of 8 patients who received VX-950 and peg-IFN in
combination for 14 days have no detectable virus in their blood at the end
of 12 additional weeks of peg-IFN+RBV dosing. These patients continue to
receive peg-IFN+RBV therapy. All patients were offered follow-on
peg-IFN+RBV treatment according to clinical practice at the investigator
sites.
"In the 14-day study, VX-950 in combination with pegylated interferon
produced a very rapid viral response in each of these genotype 1 patients,
and no serious adverse events were observed," said Henk W. Reesink, MD,
Associate Professor of Medicine at Academic Medical Center in Amsterdam,
and a lead investigator for the study. "The continued viral suppression
during follow-on therapy points to the robustness of the viral response to
VX-950 and pegylated interferon, and is encouraging for the design of
future VX-950 studies that seek to evaluate the potential for short-course,
curative therapy."
Study Design and Results
The 14-day, randomized, blinded, placebo-controlled Phase Ib study
enrolled 20 treatment-naive patients with genotype 1 HCV, the most
prevalent and difficult to treat form of HCV infection. Patients were
randomized to receive a new tablet formulation of VX-950 at a dose of 750
mg every eight hours (q8h) in combination with a standard dose of peg-IFN
(n=8), the same dose of VX-950 administered alone (n=8), or a standard dose
of peg-IFN alone (n=4). The median viral load for all patients at study
entry was 6.65 log10 IU/mL HCV RNA (approximately 4.4 million IU/mL). In
this Phase Ib study, the combination of VX-950 and peg-IFN produced an
initial median reduction in plasma HCV RNA of more than 3 log10 in the
first two days. Antiviral results for all arms after 14 days of dosing were
as follows:
* A median 5.5 log10 reduction in HCV RNA was observed in patients
receiving VX-950 and peg-IFN; 6 of 8 patients had viral levels below
the limit of quantitation (30 IU/mL) at 14 days, and 4 of 8 also
achieved viral levels below the limit of detection (10 IU/mL).
* A median 4.0 log10 reduction in HCV RNA was observed in patients
receiving VX-950 alone; 1 of 8 patients had viral levels below the
limit of detection (10 IU/mL).
* A median 1.0 log10 reduction in HCV RNA was observed in patients
receiving peg-IFN alone; no patients had viral levels below the limit of
quantitation (30 IU/mL) at 14 days.
Following the 14-day Phase Ib study, patients were rolled onto
follow-on treatment with peg-IFN and ribavirin.
Safety
A complete safety review has been conducted. All patients completed
dosing and no serious adverse events were reported. The most common adverse
events among all treatment arms, all of which were mild to moderate in
severity, were headache, myalgias, dry skin, diarrhea, nausea, chills and
rash. VX-950 did not appear to substantially increase the frequency or
severity of these events when added to peg-IFN, and the observed safety
profile supports the evaluation of VX-950 in studies of longer duration.
All adverse events in the patients receiving VX-950 alone were reported as
mild. Typical interferon-related side effects, of mild to moderate
severity, were reported in the patients that received peg-IFN along with
VX-950 or placebo.
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 3.4 million individuals in the United States, 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. Specifically targeted antiviral therapies
for HCV 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, and is one of the most
advanced investigational agents that specifically targets HCV. In early
2006, Vertex reported preliminary 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 clinical studies of up to 14 days duration, the
most common adverse events reported, including patients who did not receive
VX-950, and regardless of possible relationship to drug, have been
headache, frequent urination, gastrointestinal symptoms, myalgias, skin
disorders and chills. All of these adverse events have been reported as
mild to moderate in severity.
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 a
statement that results from the Phase Ib study are encouraging for the
design of future VX-950 studies that seek to evaluate the potential for
short-course, curative therapy. 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 full analysis of the data, or further testing, will
not reflect the interim results reported in this press release, or support
any or all of the conclusions provided in this press release, and that
clinical trials for VX-950 may not proceed as planned due to technical,
scientific, or patient enrollment issues, clinical trial results may not be
available when expected, or expected regulatory filings may not occur or
may be delayed due to adverse clinical or non-clinical trial developments
or unanticipated FDA action; and other risks listed under Risk Factors in
Vertex's Form 10-K filed with the Securities and Exchange Commission on
March 16, 2006.
Lexiva is a registered trademark of the GlaxoSmithKline group of
companies, and Pegasys is a registered trademark of Hoffman-La Roche Inc.
Vertex's press releases are available at http://www.vrtx.com.
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/
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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
Pharmaceuticals Incorporated
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