20.11.2007 22:54:00
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Vertex's Collaborator Merck Suspends Patient Enrollment in Clinical Trials of MK-0457 (VX-680) Pending Full Analysis of Clinical Data
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) and Merck & Co., Inc.
today provided an update to their collaborative Aurora kinase research
and development program, which is targeting the treatment of cancer.
Merck has suspended enrollment in clinical trials of the lead
investigational Aurora kinase inhibitor in the collaboration, MK-0457
(VX-680), pending a full analysis of all efficacy and safety data for
MK-0457. The decision was based on preliminary safety data, in which a
clinical safety finding of QTc prolongation was observed in one patient.
Merck and Vertex have a broad research and development program underway
to evaluate Aurora kinase inhibitors as novel approaches to targeted
cancer treatment. As part of Merck’s strategy
to develop multiple drug candidates in different tumor types and
treatment combinations, Merck plans to initiate in early 2008 a Phase 1
trial of VX-689 in patients with advanced and/or refractory solid tumors.
MK-0457 is being investigated in a Phase 2 trial in patients with
treatment-refractory chronic myelogenous leukemia (CML) or Philadelphia
chromosome-positive acute lymphoblastic leukemia (Ph+ALL) containing the
T315I mutation, as well as an ongoing Phase 1 clinical trial in patients
with advanced leukemias. Patients currently enrolled in these trials may
continue to be treated with MK-0457, with additional monitoring for QTc
prolongation. A recently initiated Phase 1 trial of MK-0457 in
combination with dasatinib in patients with CML or Ph+ALL has also been
suspended. In addition, development of the Aurora kinase inhibitor
MK-6592 (VX-667) has been discontinued after the compound did not meet
pharmacokinetic objectives in a Phase 1 clinical study.
About Merck Oncology
Merck Oncology focuses on all aspects of cancer care -- prevention,
treatment, and supportive care. Through strong internal research
capabilities, selective alliances and acquisitions, and enabling
technologies such as the Molecular Profiling platform of Rosetta, Merck
Oncology is looking to lead in the discovery, development and delivery
of targeted anticancer therapies customized for patient subpopulations.
Merck Oncology conducts research at sites in Boston, Seattle, West
Point, Japan and Italy.
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 focused on
viral diseases, inflammation, autoimmune diseases, cancer, pain and
bacterial infection. Vertex co-discovered the HIV protease inhibitor,
Lexiva, with GlaxoSmithKline. Vertex's press releases are available at www.vrtx.com.
Lexiva 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) Merck and Vertex expect to continue to evaluate the
clinical potential of Aurora kinase inhibitors, with the goal of
developing multiple drug candidates in different tumor types and
treatment combinations, and (ii) Merck expects to initiate a Phase 1
clinical trial of VX-689 in early 2008. 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 the
actual results of studies to vary materially. Those risks and
uncertainties include, among other things, the risk that planned studies
will not be commenced due to unanticipated scientific developments or
business constraints, that observed outcomes in clinical investigations
of smaller numbers of patients will not be reflected in clinical trials
involving larger numbers of patients, that unexpected and adverse
outcomes in ongoing clinical and nonclinical studies will occur, and
other risks listed under Risk Factors in Vertex's Form 10-K filed with
the Securities and Exchange Commission on March 1, 2007. Vertex
disclaims any obligation to update the information contained in this
press release as new data become available.
(VRTX-GEN)
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