CAMBRIDGE, Mass., June 10 /PRNewswire-FirstCall/ -- Vertex Pharmaceuticals
Incorporated (Nasdaq: VRTX) today announced the initiation of dosing in a
Phase II clinical study in rheumatoid arthritis (RA) with VX-702, an
investigational oral p38 MAP kinase inhibitor designed to inhibit cytokine
production. The study will help define the safety, tolerability and clinical
activity of VX-702 in approximately 300 patients with moderate to severe RA
treated for three months.
"Currently marketed anti-TNF agents, all of which must be administered by
injection, have established themselves as the standard of care for modifying
the course of disease in patients with moderate to severe rheumatoid
arthritis," said John Alam, M.D., Senior Vice President of Drug Evaluation and
Approval at Vertex. "The study with VX-702 will enable us to explore the
opportunity to address inflammatory diseases with this oral agent that was
designed to inhibit the production of TNF-alpha and other cytokines. This
Phase II study of VX-702 in rheumatoid arthritis is supported by the
encouraging results seen in previous studies with this compound."
p38 MAP kinase is involved in a variety of cellular processes, including
the onset and progression of inflammation. When activated, p38 MAP kinase
triggers production of cytokines TNF-alpha and IL-1beta and IL-6, which are
associated with a broad range of acute and chronic inflammatory diseases,
including RA. Based on their mechanism of action, p38 MAP kinase inhibitors
could play an important role in the future treatment of a variety of
inflammatory diseases.
Study Design
The double-blind, randomized, placebo-controlled Phase II study will
assess two doses of VX-702 compared to placebo. VX-702 will be dosed once-
daily without concomitant methotrexate. The Company expects enrollment in
this study to involve more than 40 centers in Europe. The primary endpoint of
the study is to measure the reduction in clinical signs and symptoms of RA in
patients after 12 weeks of treatment using the American College of
Rheumatology (ACR20) criteria for defining clinical improvement in RA
patients. ACR20 is a standardized measure of the number of patients who
achieve at least a 20 percent improvement in ACR-specified measurement of RA
activity. Measurements of ACR50 and ACR70 improvement will also be used to
define clinical response to treatment with VX-702. The Company expects
enrollment in the study to be completed by the end of 2005.
Vertex will conduct this trial as part of the strategic alliance formed
with Kissei Pharmaceutical Co., Ltd. in 1997 to design, develop and
commercialize orally active p38 MAP kinase inhibitors. Under the terms of
this agreement, Kissei will provide financial support for the trial. Vertex
holds development and commercial rights in the United States and Europe for
its p38 MAP kinase inhibitors. Kissei holds development and commercial rights
for VX-702 in Japan and certain Asian countries.
About Rheumatoid Arthritis
In the U.S. alone, more than two million people are afflicted with chronic
RA, causing pain, swelling, stiffness and loss of function in affected joints.
Although the cause of RA is unknown, women are three times more likely than
men to be afflicted with the disease. Anti-TNF agents are the leading
treatment for moderate to severe RA, and U.S. sales for this class of agents
reached $3.2 billion in 2004.
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(R).
Lexiva(R) is a registered trademark of the GlaxoSmithKline group of
companies.
Safe Harbor Statement
This press release may contain forward-looking statements, including
statements that (i) this Phase II study of VX-702 in rheumatoid arthritis is
supported by the encouraging results seen in previous studies with this
compound; (ii) the study with VX-702 will enable us to explore the opportunity
to address inflammatory diseases with this oral agent; (iii) p38 MAP kinase
inhibitors could play an important role in the future treatment of a variety
of inflammatory diseases; and (iv) we expect that the Phase II VX-702 study
will involve enrollment at more than 40 centers in Europe and enrollment in
the study is expected to be completed by the end of 2005. 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 clinical trials for VX-702 may not
proceed as planned due to technical, scientific, supply or patient enrollment
issues, that actual clinical studies of VX-702 will not reflect the results
obtained in nonclinical testing and other risks listed under Risk Factors in
Vertex's Form 10-K filed with the Securities and Exchange Commission on March
16, 2005.
Vertex's press releases are available at http://www.vrtx.com.
Vertex Contacts:
Lynne H. Brum, VP, Corporate Communications and Financial Planning,
(617) 444-6614
Michael Partridge, Director, Corporate Communications, (617) 444-6108
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 H. Brum, VP of Corporate Communications
and Financial Planning, +1-617- 444-6614, or Michael Partridge,
Director of Corporate Communications, +1-617- 444-6108, or Zachry
Barber, Specialist of Media Relations, +1-617-444-6470, all of
Vertex Pharmaceuticals Incorporated
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