Business Editors/Health/Medical Writers
BOULDER, Colo.--(BUSINESS WIRE)--Oct. 31, 2006--Array BioPharma
Inc. (NASDAQ: ARRY) filed an Investigational New Drug (IND)
application for ARRY-797 with the U.S. Food & Drug Administration and
is now able to proceed with human clinical studies. ARRY-797 is a
potent, selective, orally active inhibitor of p38 MAP kinase and has
demonstrated good tolerability and significant efficacy in preclinical
models of human inflammatory diseases. The compound will initially be
evaluated in dose escalation studies in normal, healthy volunteers for
safety, exposure and inhibition of mechanism-related biomarkers.
"Advancing ARRY-797, our small molecule p38 inhibitor, into
clinical trials is a significant achievement for Array and marks our
third drug to enter clinical development during 2006," said Kevin
Koch, Ph.D., President and Chief Scientific Officer. "This novel p38
inhibitor, derived from our computational de novo design technology
platform, holds promise for the treatment of patients with arthritis
and other inflammatory diseases."
About Inflammatory Disease
Inflammation is a natural biologic response to injury or
infectious attack to the human body. Unregulated inflammation results
in a broad range of conditions, most of which are classified by the
tissue or organ where the inflammation occurs. These conditions
include rheumatoid arthritis (RA) in the joint, psoriasis in the skin,
chronic obstructive pulmonary disease in the lung, fibrotic disease in
the liver and kidney, Crohn's disease in the intestine, and congestive
heart failure and arteriosclerosis in the arteries, among others.
Currently, some of the most effective treatments for these diseases
are injectable protein therapeutics, which have significant cost and
patient compliance issues. Injectable protein therapeutics currently
on the market - such as Enbrel(R), Remicade(R), Humira(R) and
Kineret(R) - bind to and/or modulate the activity of the inflammatory
cytokines TNF-(alpha) or IL-1 and are utilized for the treatment of
RA, psoriasis and Crohn's disease. The TNF inhibition market alone,
which is dominated by these therapeutics, is expected to grow from $9
billion in 2005 to $17 billion in 2010, according to analyst
estimates.
About ARRY-797 / p38 for Inflammation and Cancer
p38 MAP kinase is an enzyme that regulates the production of
numerous pro-inflammatory or growth promoting cytokines, in
particular, TNF, IL-6 and IL-1. Up-regulation of TNF and IL-6 may be
involved in certain tumor resistance mechanisms and has been observed
in several malignancies including prostate and ovarian cancer and
multiple myeloma. ARRY-797, an orally active p38 inhibitor, has
demonstrated good tolerability and significant efficacy in preclinical
models of human inflammatory diseases and certain cytokine-driven
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 life threatening and debilitating diseases.
Our proprietary drug development pipeline is focused on the treatment
of cancer and inflammatory disease and includes clinical candidates
that are designed to regulate therapeutically important protein
targets. 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 that
involve significant risks and uncertainties, including those discussed
in our annual report filed on form 10-K for the year ended June 30,
2006, 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 October 31, 2006. 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.
