AstraZeneca
(NYSE: AZN) and Array BioPharma Inc. (Nasdaq: ARRY) today announced the
initiation of a Phase II study for AZD6244 (ARRY-142886) in malignant
melanoma. AZD6244 is a selective MEK inhibitor that was in-licensed by
AstraZeneca from Array in December 2003. AstraZeneca expects the first
patient to be enrolled in this melanoma study before the end of June, which
will trigger a $3 million milestone payment to Array upon dosing the first
patient.
The trial announced today is a randomised phase II study that will
compare AZD6244 to temozolomide in the treatment of stage III / IV
melanoma. AstraZeneca expects to enroll up to 180 patients at approximately
40 centres worldwide. Additional phase II studies, in a range of other
tumours, are scheduled to start over the next two to three months. To our
knowledge AZD6244 will be the first MEK inhibitor to be evaluated in
randomised phase II studies.
Initiation of the phase II study is based on the results of the phase I
study which recently completed recruitment, and which included patients
with melanoma and a variety of other solid tumours. The phase I study
clearly demonstrated that AZD6244 inhibits MEK and associated downstream
markers in tumours at doses deemed well tolerated. The full results of this
study will be published later in the year.
Array was responsible for filing the IND and conducting the Phase I
clinical testing of AZD6244. AstraZeneca is responsible for all other
aspects of clinical development and commercialisation.
"Array has delivered an extremely successful phase I study and has
brought AZD6244 to this important milestone and transition," said Brent
Vose, Vice President and Head of Oncology & Infection, AstraZeneca. "We are
now looking forward to building on the significant contribution made by
Array and to continuing to move forward with the development of this
compound, which we believe has the potential to bring real benefits to
people with cancer."
"We believe that AZD6244 holds great promise for cancer patients and we
look forward to the initiation of the Phase II trials," said Kevin Koch,
Ph.D., President and Chief Scientific Officer, Array BioPharma. "We're
pleased to be working with AstraZeneca's experienced oncology team and
we're excited about their strong commitment to bringing this novel
treatment to people with cancer."
AstraZeneca acquired exclusive worldwide rights to AZD6244 and certain
second-generation compounds for all oncology indications in December 2003.
Array retains the rights to all therapeutic indications outside of oncology
for compounds not selected by AstraZeneca as part of the collaboration.
About AZD6244
AZD6244 is a potent, selective MEK inhibitor that is orally active,
that blocks signal transduction pathways implicated in cancer cell
proliferation and survival. AZD6244 has shown tumour suppressive activity
in multiple pre-clinical models of human cancer including melanoma,
pancreatic, colon, lung, and breast cancers.
About MEK Inhibition
MEK is a critical enzyme at the intersection of several biological
pathways, which regulates cell proliferation and survival as part of the
Ras/Raf/MEK/ERK pathway. Activation of the Ras/Raf/MEK/ERK pathway has been
implicated in many cancers, including lung, pancreatic, colon, melanoma and
thyroid cancer. MEK inhibition is an attractive anti-cancer strategy as it
has the potential to block inappropriate signal transduction regardless of
the upstream position of the oncogenic aberration.
About Melanoma
More than 80,000 people are diagnosed with malignant melanoma each
year, approximately 20% of them with advanced disease. Current treatments
for advanced melanoma offer little survival benefit and are associated with
considerable toxicities for the majority of patients. The outlook for
patients with metastatic disease is poor with median survival time of
between 6-12 months and a 5-year survival rate of approximately 10%. There
is a great need for new and effective treatments for advanced melanoma that
can extend the life of patients and improve their quality of life while
receiving treatment by reducing the burden of toxicities associated with
today's treatments.
About AstraZeneca
AstraZeneca is a major international healthcare business engaged in the
research, development, manufacture and marketing of prescription
pharmaceuticals and the supply of healthcare services. It is one of the
world's leading pharmaceutical companies with healthcare sales of $23.95
billion and leading positions in sales of gastrointestinal, cardiovascular,
neuroscience, respiratory, oncology and infection products. AstraZeneca is
listed in the Dow Jones Sustainability Index (Global) as well as the
FTSE4Good Index. For further information please visit
astrazenecapressoffice.
About Array BioPharma
Array BioPharma is a biopharmaceutical company focused on the
discovery, development and commercialization of orally active drugs to
address significant unmet medical needs. Our proprietary drug development
pipeline is primarily focused on the treatment of cancer and inflammatory
disease and includes several small molecule drug candidates that are
designed to regulate targets in therapeutically important biologic
pathways. In addition, leading pharmaceutical and biotechnology companies
access our drug discovery technologies and expertise through collaborations
to design, create, optimize and evaluate drug candidates across a broad
range of therapeutic areas. For more information on Array, please go to
arraybiopharma.
Array BioPharma's Forward-Looking Statement
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that
involve significant risks and uncertainties, including those discussed in
our annual report filed on form 10-K for the year ended June 30, 2005, and
in other reports filed by Array with the Securities and Exchange
Commission. Because these statements reflect our current expectations
concerning future events, our actual results could differ materially from
those anticipated in these forward-looking statements as a result of many
factors. These factors include, but are not limited to, our ability to
achieve and maintain profitability, the extent to which the pharmaceutical
and biotechnology industries are willing to in-license drug candidates for
their product pipelines and to collaborate with and fund third parties for
their drug discovery activities, our ability to out-license our proprietary
candidates on favorable terms, our ability to continue to fund and
successfully progress internal research efforts and to create effective,
commercially viable drugs, risks associated with our dependence on our
collaborators for the clinical development and commercialization of our
out-licensed drug candidates, the ability of our collaborators and of Array
to meet drug objectives, including clinical trials, tied to milestones and
royalties, and our ability to attract and retain experienced scientists and
management. We are providing this information as of June 8, 2006. We
undertake no duty to update any forward- looking statements to reflect the
occurrence of events or circumstances after the date of such statements or
of anticipated or unanticipated events that alter any assumptions
underlying such statements.
Array BioPharma Inc.
arraybiopharma
astrazenecapressoffice