Array BioPharma To Present Clinical Data On ARRY-797 At The 2012 American College Of Rheumatology Annual Meeting
BOULDER, Colo., Nov. 6, 2012 /PRNewswire/ -- Array BioPharma Inc. (NASDAQ: ARRY) announced that an abstract discussing the final Phase 2 trial results with ARRY-797 in patients with osteoarthritis pain will be presented at the 2012 American College of Rheumatology Annual Meeting in Washington, D.C. This abstract includes data on ARRY-797's analgesic effect and markers of disease modification. In addition, biomarkers of cartilage (COMP) and bone (CTX?I) degradation were assessed. ARRY?797 treatment resulted in statistically significant decreases in COMP and CTX?I at week 4 (decreases of 10% and 38% versus placebo, respectively). The decrease in CTX?I was sustained and returned to baseline by the follow?up visit. The abstract concludes that further evaluation of the potential for disease modifying activity is warranted.
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The abstract can be accessed through the American College of Rheumatology Annual Meeting website, http://www.rheumatology.org/apps/MyAnnualMeeting/ExploreMeeting. After the presentation, the poster will be available as a PDF on Array's website at www.arraybiopharma.com.
Poster:
A Randomized, Placebo-Controlled Phase 2 Study of ARRY-797 in
Patients with Osteoarthritis Pain Refractory to NSAID Treatment
Showed Statistically Significant Improvements in WOMAC Pain and in
Biomarkers of Bone and Cartilage Degradation
Session:
Late Breaking Abstracts
Date:
Tuesday, November 13, 2012
Time:
9:00 - 11:00 AM Eastern Time
Location:
Walter E. Washington Convention Center - Poster Hall (Hall
B)
Array announced in July 2012 that ARRY-797, a non-opioid, met its
primary endpoint in a randomized, placebo-controlled and
active-controlled (oxycodone ER) Phase 2 clinical trial in 157
osteoarthritis patients suffering from moderate to severe knee pain
despite the use of non-steroidal anti-inflammatory drugs
(NSAIDs). Patients in all treatment groups continued using
NSAIDs throughout the trial. ARRY-797 is a novel, oral, selective
p38 inhibitor with a mechanism of action unique from that of
currently approved pain medications. Given our internal focus
on hematology/oncology, Array is in active discussions with
potential partners to maximize the value of this drug.
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. Array
is evolving into a late-stage development company, with two
wholly?owned programs, ARRY-614 and ARRY-520, and three partnered
programs, selumetinib (with AstraZeneca), MEK162 (with Novartis),
and danoprevir (with InterMune / Roche), having the potential to
begin Phase 3 or pivotal trials by the end of calendar year
2013. 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 the timing of the announcement of the
results of clinical trials and the development plans for ARRY-797,
expectations that events will occur that will result in greater
value for the Company, the potential for the results of ongoing
preclinical and clinical trials to support regulatory approval or
the marketing success of ARRY-797, and our ability to partner
ARRY-797for up-front fees, milestone and/or royalty payments and to
maximize the value for Array. These statements involve significant
risks and uncertainties, including those discussed in our most
recent annual report filed on Form 10-K, in our quarterly reports
filed on Form 10-Q, 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 and development
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
objectives tied to milestones and royalties; our ability to
effectively and timely conduct clinical trials in light of
increasing costs and difficulties in locating appropriate trial
sites and in enrolling patients who meet the criteria for certain
clinical trials; risks associated with our dependence on
third-party service providers to successfully conduct clinical
trials within and outside the United States; our ability to achieve
and maintain profitability and maintain sufficient cash resources;
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; and our ability to
attract and retain experienced scientists and management. We are
providing this information as of November 6, 2012. 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.
CONTACTS:
Array BioPharma Inc.
Tricia Haugeto
(303) 386-1193
SOURCE Array BioPharma Inc.
Web Site: http://www.arraybiopharma.com
Posted: November 2012
