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Array BioPharma Inc. (ticker: ARRY, exchange: NASDAQ) News Release -
3/5/2004
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Array BioPharma's Anticancer Compound ARRY-142886 Cleared to Advance
Into Human Clinical Trials
- Phase I Trial Expected to Commence in Spring 2004 -
BOULDER, Colo., March 5 /PRNewswire-FirstCall/ -- Array BioPharma
Inc. (Nasdaq: ARRY) received notification from the U.S. Food & Drug
Administration that its investigational new drug (IND) application is
now in effect for ARRY-142886 (AZD6244), allowing Array to proceed
with human clinical studies in cancer patients. ARRY-142886
(AZD6244), the Company's first small molecule anticancer compound,
interferes with MEK, one step in a critical cellular
hyperproliferation pathway in human cancer cells. Oral administration
of ARRY-142886 (AZD6244) in certain preclinical skin, pancreatic,
colon, lung and breast tumor models resulted in tumor suppression and
regression.
"The clearance to advance ARRY-142886 (AZD6244) into human clinical
trials is a significant achievement for Array and further
demonstrates our ability to create high quality clinical candidates,"
said Kevin Koch, Ph.D., President and Chief Scientific Officer. "We
continue to build a strong pipeline of orally active drug candidates
focused on cancer and inflammatory disease, and we plan to advance
select programs to Phase II clinical proof of concept."
In December 2003, AstraZeneca PLC acquired exclusive, worldwide
rights to ARRY-142886 (AZD6244) and related intellectual property for
oncology indications. Array is responsible for the IND filing and
performing a Phase I clinical trial. AstraZeneca will be responsible
for all other aspects of clinical development and commercialization.
Array plans to commence the Phase I trial this spring at two academic
medical centers in the United States. The trial is designed to
evaluate tolerability and pharmacokinetics of ARRY-142886 (AZD6244)
following oral administration to patients with advanced cancer. In
addition, the trial is designed to examine patients for indications
of biological activity as well as pharmacodynamic and tumor
biomarkers.
/CONTACT:
Tricia Haugeto of Array BioPharma Inc., +1-303-386-1193,
thaugeto@.../
/Web site: http://www.arraybiopharma.com
http://www.astrazenecapressoffice.com / (ARRY)
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