ERX - don't go near,rumour likely to go bust anyday

Merck and Vertex Announce Start of Pivotal Phase 2 Clinical Trial for Treatment-Resistant Forms of Advanced Leukemias



WHITEHOUSE STATION, N.J. and CAMBRIDGE, Mass., Dec. 21 /CNW/ -- Merck &
Co., Inc. (NYSE: MRK) and Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX)
today announced the start of an international clinical trial of MK-0457 (also
known as VX-680), an investigational small molecule inhibitor of Aurora,
FLT-3, JAK-2 and BCR-ABL kinases. The trial will be conducted in patients
with treatment resistant chronic myelogenous leukemia (CML) and Philadelphia
chromosome-positive acute lymphocytic leukemia (Ph+ ALL) containing the T315I
BCR-ABL mutation. In connection with the start of dosing in the trial, which
is designed to support registration of MK-0457 in the United States and other
countries, Vertex earned a $25 million milestone payment from Merck.
"This pivotal trial based on a population prospectively defined by a
genetic marker will hopefully represent a new paradigm for development of
drugs targeting specific cancer patient populations," said Stephen H. Friend,
M.D., Ph.D., Executive Vice President and Franchise Head, Oncology and
Neuroscience, Merck Research Laboratories. "MK-0457 is the first compound to
show clinical activity in patients with certain treatment-resistant forms of
blood cancers. Based on encouraging Phase 1 results reported recently at the
American Society of Hematology meeting, we are moving forward with this
international Phase 2 clinical trial in these patients."



Merck will conduct the international Phase 2 clinical trial of MK-0457 at
various sites in the United States, the European Union, and several other
countries, including Israel. The trial is expected to enroll approximately 270
adult patients with advanced CML and ALL leukemias harboring the T315I BCR-ABL
mutation. Patients in the study will be enrolled in one of four cohorts:
patients with accelerated phase CML, patients with blast phase CML, patients
with chronic phase CML and patients with Philadelphia chromosome-positive ALL
with the T315I mutation. In the trial, MK-0457 will be given as a five-day
intravenous infusion every two to three weeks to evaluate both safety and
efficacy. Merck may seek marketing approval for MK-0457 based on the data
generated in this trial. The trial has been designed to support registration
of MK-0457 in one or more cancer indications for which there is currently
little or no effective treatment.
The trial is now open for patient recruitment. If interested in more
information about the trial, please visit www.clinicaltrials.gov or call 1-
888-577-8839. The ClinicalTrials.gov identifier for this trial is
NCT00405054.



Cancer cells typically contain mutations in a number of genes, which
ultimately result in uncontrolled cell growth and tumor metastasis. As
enzymes specific for and essential to cell growth and division, Aurora kinases
hold the potential to be important control points for slowing the growth and
spread of tumors. Aurora kinases are a family of serine-threonine kinases
that are believed to play multiple roles in the development and progression of
cancer, by acting as regulators of cell proliferation, by transforming normal
cells into cancer cells and by down-regulating p53, one of the body's natural
tumor suppressors. Aurora kinases are known to be over-expressed in many tumor
types.



MK-0457 was discovered by scientists at Vertex's Oxford, U.K. research
site as part of a broad research effort targeting the kinase gene family.
Vertex researchers published the three-dimensional atomic crystal structure of
Aurora-A kinase in 2002, a key scientific advance that enabled the design and
optimization of multiple classes of small molecule Aurora kinase inhibitors.
MK-0457 advanced to preclinical development in 2002, following evaluation of
the compound's activity in tumor cell lines and in animal models of tumor
growth. In studies published in early 2004, Vertex demonstrated that MK-0457
induced tumor regression in xenograft models of human pancreatic and colon
cancer. In addition, studies conducted by Vertex showed that MK-0457
prolonged survival and induced sustained remission in an oncogene-driven model
of human acute myelocytic leukemia (AML).
In June 2004, Vertex entered into a global collaboration with Merck to
develop and commercialize MK-0457 (VX-680) and other follow-on Aurora kinase
inhibitors. As part of the collaboration, Vertex and Merck conducted a joint
research program to characterize MK-0457's (VX-680) activity across a broad
range of cancer types and identified additional drug candidates targeting the
Aurora kinases.



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.



Merck & Co., Inc. is a global research-driven pharmaceutical company
dedicated to putting patients first. Established in 1891, Merck currently
discovers, develops, manufactures and markets vaccines and medicines to
address unmet medical needs. The company devotes extensive efforts to
increase access to medicines through far-reaching programs that not only
donate Merck medicines but help deliver them to the people who need them.
Merck also publishes unbiased health information as a not-for-profit service.
For more information, visit www.merck.com.



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.