BOULDER, Colo.--(BUSINESS WIRE)--Dec. 19, 2007--Array BioPharma
Inc. (NASDAQ: ARRY) today announced initial results from a randomized
Phase 2 study comparing AZD6244 (ARRY-886) monotherapy with
temozolomide (Temodar(R), an alkylating agent) in the first-line
treatment of advanced melanoma. There was no apparent difference in
efficacy between AZD6244 and temozolomide for the primary endpoint
(Progression Free Survival). AstraZeneca, which licensed AZD6244 from
Array in 2003, was responsible for running the Phase 2 trial.
Based on the results of this study, AstraZeneca does not plan to
progress AZD6244 as a monotherapy into a Phase 3 trial in patients
with advanced melanoma at this time, although anti-tumor activity was
detected. AstraZeneca is exploring other options to further develop
this compound.
In addition, AstraZeneca recently completed analysis on two
smaller monotherapy signal searching studies in 3rd line advanced
colorectal cancer (CRC) and 2nd line advanced non-small cell lung
cancer (NSCLC). Neither of these studies reached their primary
endpoint of delaying disease progression versus the randomized
comparators in the overall population; however, there was evidence of
anti-tumor activity in the NSCLC study.
The data from these studies will be presented at forthcoming
medical congresses. AstraZeneca remains committed to the evaluation of
MEK inhibitors and to better define their use in oncology clinical
practice.
Array will hold a conference call on Thursday, December 20, 2007,
at 9:00 a.m. eastern time to discuss these results. Robert E. Conway,
Chief Executive Officer, will lead the call.
Conference Call Information
Date: Thursday, December 20, 2007
Time: 9:00 a.m. eastern time
Toll-Free: 877-852-6575
Toll: 719-325-4777
Pass Code: 3043001
Web Cast: www.arraybiopharma.com
A replay of the call will be available as a webcast on
www.arraybiopharma.com and by phone for one week by dialing toll-free
(888) 203-1112 or (719) 457-0820. The access code is 3043001.
About AZD6244 (ARRY-886)
AZD6244 is an anti-cancer drug in Phase II development in a range
of tumours.
It is a small molecule inhibitor that targets a key position in
the Ras/Raf/MEK/ERK signalling pathway. This pathway is implicated in
the development and progression of cancers.
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 and
inflammatory diseases. 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.
About Array's Proprietary Drug Development Pipeline
Array's pipeline includes four cancer and two inflammatory disease
programs, which were all invented at Array and are owned 100% by the
Company, including:
- ARRY-543, an ErbB-2 / EGFR dual inhibitor, entering multiple
Phase 1b/2 clinical studies in cancer patients over the next
12 months;
- ARRY-797, a novel p38 inhibitor, in a Phase 2 clinical trial
to treat patients with post-operative dental pain and planning
to study it in other inflammatory diseases;
- ARRY-162, a MEK inhibitor for inflammatory disease, which
recently completed a Phase 1b trial in combination with
methotrexate in patients with stable rheumatoid arthritis
(RA). Array plans to begin a Phase 2 trial with ARRY-162 in RA
patients in early 2008;
- ARRY-520, a small molecule Kinesin Spindle Protein (KSP)
inhibitor, in a Phase 1 clinical trial in cancer patients;
- ARRY-380, an oral, selective ErbB-2 inhibitor, in a Phase 1
clinical trial in cancer patients;
- ARRY-614, a p38 / Tie-2 inhibitor, which has completed
regulated safety assessment testing. Array is preparing an IND
application and plans to file it over the next month.
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, 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 tied
to milestones and royalties, and our ability to attract and retain
experienced scientists and management. We are providing this
information as of December 19, 2007. 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.