April 29, 2006
Source URL...
http://www.vrtx.com/Pressreleases2006/pr042906.html
Researchers
Report Initial Results for 14-day Phase Ib Study of VX-950, and Pegylated
Interferon, Showing Anti-HCV Activity in Combination in Hepatitis C
Patients
—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, 2006– 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‚; 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® assay), and 4 of 8 patients had HCV RNA levels
below the limit of detection (10 IU/mL, Roche TaqMan®). 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.
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-naïve 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. In collaboration
with GlaxoSmithKline, Vertex co-promotes the HIV protease inhibitor,
Lexiva.
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 (i) 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 (ii) 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 Contact:
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
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