BOULDER, Colo.--(BUSINESS WIRE)--Nov. 20, 2007--Array BioPharma
Inc. (NASDAQ: ARRY) today announced that it has commenced dosing
ARRY-797, a novel, small molecule p38 inhibitor, in a Phase 2 clinical
trial to evaluate the efficacy of this drug for treating pain in
dental patients undergoing third molar extraction.
"I am delighted that we are now dosing patients in our Phase 2
study to evaluate the efficacy of ARRY-797 in the management of
postoperative dental pain," said John Yates, MB ChB, MD, Chief Medical
Officer, Array BioPharma. "We believe we are likely to see significant
efficacy in acute pain based upon ARRY-797's pharmacodynamic
activities to date. This model has been a good predictor of acute
analgesic effects of various pain medications."
The Phase 2 trial is a randomized, double-blind,
placebo-controlled, parallel-group efficacy study of ARRY-797 in
dental patients undergoing third molar extraction. The objective of
the study is to assess the safety, tolerability and analgesic efficacy
of ARRY-797 dosed either after the operation or both before and after
surgery. Although analgesics are typically administered with the onset
of pain, emerging evidence suggests that dosing an anti-inflammatory
drug prior to a surgical procedure can help block the development of
pain. The trial will enroll 150 patients and be conducted at two
centers in the United States.
ARRY-797 / p38 Inhibitor Phase 1 Results
In a single ascending dose (SAD) study in healthy volunteers,
ARRY-797 was shown to have linear increases in exposure with
increasing oral dose; the dose range studied was from 25 to 400 mg.
The drug was well-tolerated with no serious adverse events. In blood
samples taken from these volunteers and stimulated ex vivo, ARRY-797
was shown to inhibit the production of IL-1beta, TNF-alpha and PGE2.
These effects were pronounced, with up to 80 to 90 percent inhibition
of these inflammatory mediators seen at the higher doses. ARRY-797 met
its objective in this study and is nearing completion in a multiple
ascending dose (MAD) study in normal volunteers.
About ARRY-797 / Targeting p38 for Inflammation and Pain
P38 is a kinase target that regulates the production of numerous
pro-inflammatory cytokines, in particular, TNF, IL-1, IL-6 and PGE2.
Based upon its potential to reduce the synthesis of multiple
pro-inflammatory mediators from diverse cell types and block key
secondary inflammatory pathways at an early stage, blockade of p38
kinase activity provides a novel therapeutic approach for the
treatment of inflammation and inflammatory pain.
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.
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 November 20, 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
CONTACT: Array BioPharma Inc.
Tricia Haugeto, 303-386-1193
SOURCE: Array BioPharma Inc.