BOULDER, Colo.--(BUSINESS WIRE)--March 25, 2008--Array BioPharma
Inc. (NASDAQ: ARRY) filed an Investigational New Drug (IND)
application for ARRY-614 with the U.S. Food & Drug Administration and
has initiated a Phase 1 clinical trial. ARRY-614, a potent, orally
active p38 / Tie2 inhibitor, has shown good efficacy and a low side
effect profile in preclinical models of human cancer and arthritis.
The compound will initially be evaluated in a single and multiple dose
escalation study in normal, healthy volunteers for safety,
tolerability, exposure and inhibition of mechanism-related biomarkers.
"We believe the dual inhibition of p38 and Tie2 may produce
additive and/or synergistic effects with other therapies in treating
multiple myeloma and other cancers as well as certain inflammatory
diseases," said John Yates, M.D., Chief Medical Officer. "We look
forward to seeing ARRY-614's clinical progress so we can test this
hypothesis."
Targeting p38 and Tie2 for Inflammation and Cancer
P38 is a kinase target that regulates the production of PGE2 as
well as numerous pro-inflammatory cytokines, in particular, TNF, IL-6
and IL-1. These cytokines can also act as cellular growth factors and
are often up-regulated in certain cancers including prostate, ovarian
and multiple myeloma. Additionally, p38 may play a role in certain
resistance mechanisms or metastatic progression in cancer. Tie2, a
receptor tyrosine kinase, plays an important role in angiogenesis and
blood vessel growth which may lead to uncontrolled cell growth that
characterizes a number of cancer and chronic inflammatory diseases.
About Array BioPharma
Array BioPharma Inc. is a biopharmaceutical company focused on the
discovery, development and commercialization of targeted small
molecule drugs to treat patients afflicted with cancer, inflammatory
diseases and pain. Our proprietary drug development pipeline includes
clinical candidates that are designed to regulate therapeutically
important target proteins and are aimed at large market opportunities.
In addition, leading pharmaceutical and biotechnology companies
collaborate with Array to discover and develop drug candidates across
a broad range of therapeutic areas. For more information on Array,
please go to www.arraybiopharma.com.
Forward-Looking Statement
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995,
including statements about our future plans for advancing certain of
our proprietary drug programs, the potential to earn future milestone
payments, license fees or royalty revenue, the expected progress and
success of our internal proprietary drug discovery activities and the
development activities of our collaborators, and the plans of our
collaborators to further develop drugs we have out-licensed or on
which we are collaborating. These statements involve significant risks
and uncertainties, including those discussed in our annual report
filed on form 10-K for the year ended June 30, 2007, 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
continue to fund and successfully progress internal research efforts
and to create effective, commercially viable drugs, 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 on their drug discovery activities, our ability
to out-license our proprietary candidates on favorable terms, 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 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 March 25, 2008. 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.
CONTACT: Array BioPharma Inc.
Tricia Haugeto, 303-386-1193
thaugeto@arraybiopharma.com
SOURCE: Array BioPharma Inc.
