-- Presentation of Study Results Planned at DDW --
CAMBRIDGE, Mass., May 10 /PRNewswire-FirstCall/ -- Vertex Pharmaceuticals
Incorporated (Nasdaq: VRTX) today announced interim results that indicate that
the investigational oral hepatitis C virus (HCV) protease inhibitor VX-950 was
well-tolerated and demonstrated potent antiviral activity in a Phase Ib
clinical trial.
The study enrolled 34 patients with chronic genotype 1 HCV infection who
were treated for 14 days with placebo or one of three dose regimens of VX-950.
Patients receiving 750 mg of VX-950 every eight hours achieved a median
reduction in HCV-RNA of greater than 4 log10, equivalent to a more than
10,000-fold decrease in viral levels, at the end of 14 days of treatment. A
median reduction in HCV-RNA of greater than 2 log10 was seen in each of the
other two VX-950 dose groups at the end of 14 days of treatment. Every
patient receiving VX-950 achieved greater than a 2 log10 reduction in HCV-RNA
within the first three days of treatment. Genotype 1 HCV infection is the
most difficult strain of HCV to treat and the most prevalent strain in the
United States, Western Europe and Japan. Results from the study will be
presented by a clinical investigator on May 17, 2005 at Digestive Disease
Week(R) (DDW), a medical conference to be held in Chicago, Illinois. In
accordance with the embargo policy of the meeting, the specific data from the
trial beyond what is described in this press release will not be disclosed
until the DDW presentation.
"Vertex is committed to developing innovative compounds for the treatment
of chronic HCV infection. VX-950, one of the most advanced agents in a
promising new class of direct antivirals, underscores that commitment," said
Joshua Boger, Ph.D., Chairman and Chief Executive Officer of Vertex. "The
demonstration of antiviral activity in this early clinical study is highly
encouraging, and we look forward to sharing these data in greater detail at
DDW next week."
Based on the results of the Phase Ib clinical study, the Company plans to
explore the development of VX-950 as monotherapy and in combination with other
HCV treatments. Vertex plans to consult with the U.S. FDA and European
regulatory authorities on the Company's development plans. Vertex expects to
file an investigational new drug (IND) application in the second half of 2005
to support Phase II clinical development of VX-950 in the United States. In
collaboration with Vertex, Mitsubishi Pharma Corporation is developing VX-950
in Japan and certain Far East countries.
Trial Design
The Phase Ib clinical trial was a double-blind, randomized placebo-
controlled study designed to evaluate the tolerability, pharmacokinetics and
effect on viral kinetics of three doses of VX-950 -- 450 mg every 8 hours,
1250 mg every 12 hours, or 750 mg every 8 hours -- over a period of 14 days,
with additional post-treatment follow-up. A key goal of the study was to
assess different dosing levels and frequencies for VX-950 to provide insight
into dose selection for future monotherapy and combination therapy studies.
Thirty-four patients with chronic genotype 1 hepatitis C virus infection were
enrolled in the study; six patients received placebo and 28 patients received
VX-950. The study was conducted at three centers in Europe. The trial
included treatment-experienced and treatment-naive HCV-infected patients.
VX-950 Demonstrates Antiviral Activity
Interim Phase Ib clinical trial results indicate that VX-950 was well-
tolerated across all three dose groups with no serious adverse events
reported, and no treatment discontinuations. Treatment with VX-950 also
resulted in significant reductions in plasma HCV-RNA. Within three days of
treatment, the median reduction in HCV-RNA was greater than 3 log10 in all
three VX-950 dose groups. In the dose group receiving 750 mg of VX-950 every
8 hours, there was a further reduction in viral levels between days 3 and 14
of treatment, with mean and median HCV-RNA reductions of greater than 4 log10
at day 14. Trough plasma concentrations of VX-950 were highest in the 750 mg
every 8 hour dose group. In the 450 mg q8h and 1250 mg q12h dose groups,
maximal effects were seen between days 3 and 7 of treatment. Subsequently,
there was an increase of approximately 1 log10 in median HCV-RNA between days
7 and 14 evident in both groups. Full analysis of the study, including a
detailed pharmacokinetic and viral sequencing evaluation, is underway.
Web Cast Conference Call on May 17
Following the presentation of VX-950 clinical data at DDW, Vertex
Pharmaceuticals will host a conference call on May 17, 2005 at 4:00 p.m.
Eastern Daylight Time (EDT). This call will be broadcast live via the
Internet at http://www.vrtx.com in the investor center until end of day on May
30, 2005. Alternatively, to listen to the call live on the telephone, dial
(800) 374-0296 (U.S. and Canada) or (706) 634-2224 (International). The
archived call will be available via telephone commencing May 17, 2005 at 8:00
p.m. EDT through 5:00 p.m. EDT on May 23, 2005. The replay phone number for
the U.S. and Canada is (800) 642-1687. The international replay number is
(706) 645-9291. The conference ID number is 6231209 for both numbers.
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(R), with GlaxoSmithKline.
Safe Harbor Statement
This press release may contain forward-looking statements, including
statements that (i) Vertex's HCV protease inhibitor VX-950 is well-tolerated
and possesses potent antiviral activity; (ii) that Vertex expects to explore
development of VX-950 as monotherapy and as part of combination therapy; and
(iii) Vertex plans to file an IND during the second half of 2005 to support
clinical development of VX-950 in the United States. 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, 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; and other risks listed under Risk
Factors in Vertex's Form 10-K filed with the Securities and Exchange
Commission on March 16, 2005.
Lexiva(R) is a registered trademark of the GlaxoSmithKline group of
companies.
Vertex's press releases are available at http://www.vrtx.com.
Vertex Contacts:
Lynne Brum, VP, Corporate Communications and Financial Planning,
(617) 444-6614
Michael Partridge, Director, Corporate Communications, (617) 444-6108
Lora Pike, Manager, Investor Relations, (617) 444-6755
Zachry Barber, Specialist, Media Relations, (617) 444-6470
SOURCE Vertex Pharmaceuticals Incorporated
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Related links:
http://www.vrtx.com
Company News On-Call:
http://www.prnewswire.com/comp/938395.html
CONTACT:
Lynne Brum, VP, Corporate Communications and
Financial Planning, +1-617-444-6614, or Michael Partridge,
Director, Corporate Communications, +1-617-444-6108, or Lora
Pike, Manager, Investor Relations, +1-617-444-6755, Zachry
Barber, Specialist, Media Relations, +1-617-444-6470, all of
Vertex Pharmaceuticals Incorporated
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