- Phase I Trial Expected to Commence in Fall 2005 -
BOULDER, Colo., Aug. 8 /PRNewswire-FirstCall/ -- Array BioPharma Inc.
(Nasdaq: ARRY) has an Investigational New Drug (IND) application now in effect
with the U.S. Food & Drug Administration for ARRY-334543, allowing Array to
proceed with human clinical studies in cancer patients. ARRY-334543, the
Company's second small molecule anticancer compound, is a dual growth factor
inhibitor, which disrupts both ErbB-2 and EGFR, two critical targets
regulating cellular hyperproliferation pathways in human cancers. Oral
administration of ARRY-334543 in preclinical models of human breast, lung, or
epidermal carcinoma tumors resulted in significant anti-tumor activity.
"Advancing ARRY-334543 into clinical trials is a significant achievement
for Array and further demonstrates our ability to invent novel therapies for
cancer patients," said Kevin Koch, Ph.D., President and Chief Scientific
Officer. "Our goal is to continue building the industry's leading clinical
pipeline of small molecule drugs, driving Array's future growth."
Array plans to commence the Phase I clinical trial this fall at two
academic medical centers in the United States and Canada. The open-labeled,
dose-escalation trial is designed to evaluate tolerability and
pharmacokinetics of ARRY-334543 following oral administration to patients with
advanced cancer. In addition, the trial is designed to examine indicators of
therapeutic activity in these patients.
ARRY-334543 is an orally active, reversible, enzymatic and cellular
inhibitor, with nanomolar potency, of the key growth factor receptor tyrosine
kinases ErbB-2 and EGFR. The compound possesses improved physiochemical
properties relative to compounds directed at these targets currently in
clinical development, and provides superior exposure and equivalent or greater
efficacy in animal models of human cancer.
We believe that ARRY-334543, which concurrently inhibits the molecular
targets of the drugs Herceptin(R) (ErbB-2) and Erbitux(R) (EGFR), will provide
enhanced efficacy in the treatment of cancer patients. Currently, there is no
single drug on the market that selectively inhibits both ErbB-2 and EGFR.
About Array BioPharma:
Array BioPharma is a biopharmaceutical company focused on the discovery,
development and commercialization of orally active drugs to address
significant unmet medical needs. Our proprietary drug development pipeline is
primarily focused on the treatment of cancer and inflammatory disease and
includes several small molecule drug candidates that are designed to regulate
targets in therapeutically important biologic pathways. In addition, leading
pharmaceutical and biotechnology companies access our drug discovery
technologies and expertise through collaborations to design, create, optimize
and evaluate 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 that involve
significant risks and uncertainties, including those discussed in our annual
report filed on form 10-K for the year ended June 30, 2004, 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 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 for their drug
discovery activities, our ability to out-license our proprietary candidates on
favorable terms, our ability to continue to fund and successfully progress
internal research 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 drug objectives, including
clinical trials, tied to milestones and royalties, and our ability to attract
and retain experienced scientists and management. We are providing this
information as of August 8, 2005. 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.
SOURCE Array BioPharma Inc.
CONTACT: Tricia Haugeto of Array BioPharma Inc., +1-303-386-1193,
Web site: http://www.arraybiopharma.com