- Initiates Dosing ARRY-403 in Patients with Type 2 Diabetes in Phase 1
Multiple Ascending Dose Trial -
BOULDER, Colo.--(BUSINESS WIRE)--Oct. 1, 2009--
Array BioPharma Inc. (NASDAQ: ARRY) today announced that a poster on
ARRY-403, a novel, oral, glucokinase activator (GKA), will be presented
at the European Association for the Study of Diabetes annual meeting, on
October 2, 2009, in Vienna, Austria. The poster will provide preclinical
and Phase 1 single ascending dose (SAD) clinical data on ARRY-403. The
poster will be available as a PDF after it is presented on Array's
website at: www.arraybiopharma.com.
The data presented are consistent with the positive top-line results
announced in August 2009 showing that ARRY-403 met its primary and
secondary endpoints of safety, pharmacokinetics and glucose control in a
Phase 1 SAD study. The study included seven dose cohorts, with a total
of 41 patients with type 2 diabetes who received either placebo or a
single dose of ARRY-403 ranging from 25 mg to 400 mg. ARRY-403 was well
tolerated at all doses. ARRY-403 was rapidly absorbed, and exposure was
dose-dependent. The pharmacokinetic profile is consistent with
once-daily therapeutic dosing. ARRY-403 provided dose-dependent
reduction in glucose excursions in response to a standardized meal as
well as reduction in 24-hour fasting blood glucose.
Based on these positive results, Array initiated a multiple ascending
dose study and recently started dosing patients with type 2 diabetes to
evaluate safety, exposure and glucose control over a 10-day period.
About Diabetes
According to the Centers for Disease Control, approximately 24 million
(8 percent) Americans have diabetes. Current therapies for this
progressive disease are insufficient or have unwanted side-effects
creating a need for the development of novel therapeutic approaches.
GKAs, such as ARRY-403, represent a promising new class of drugs for the
treatment of type 2 diabetes.
About Glucokinase Activation
In normal individuals, the pancreas secretes insulin in response to
increased levels of glucose in the blood. Glucokinase (GK) is the enzyme
that senses glucose in the pancreas. GK also increases glucose
utilization and decreases glucose production in the liver. In patients
with type 2 diabetes, there is a reduction of GK activity in the
pancreas and the liver. Activating GK lowers blood glucose levels by
enhancing the ability of the pancreas to sense glucose, which leads to
increased insulin production. Simultaneously, GKAs increase the net
uptake of blood glucose by the liver and decrease the production of
glucose by the liver.
About ARRY-403
In multiple well-established preclinical in vivo models of type 2
diabetes, ARRY-403 is highly efficacious in controlling both fasting and
non-fasting blood glucose, with rapid onset of effect and maximal
efficacy within 5 to 8 once daily doses. When combined with existing
standard-of-care drugs (metformin, sitagliptin, and pioglitazone),
ARRY-403 provided additional glucose control, and reached maximal
efficacy after 5 to 7 once daily doses. ARRY-403 did not increase body
weight, plasma triglycerides or total cholesterol, whether used as
monotherapy or in combination with other diabetes drugs.
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, inflammatory diseases,
pain and metabolic diseases. Our proprietary drug development pipeline
includes clinical candidates that are designed to regulate
therapeutically important target proteins and are aimed at significant
unmet medical needs. 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 our future plans for advancing certain of our
proprietary drug programs, the timing and scope of our plans to grow our
clinical development and commercialization capabilities, the potential
to earn future milestone payments, license fees or royalty revenue, the
potential for the results of ongoing preclinical and clinical trials to
support regulatory approval or the marketing success of a drug
candidate, 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 reports filed on form 10-K, 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; 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; 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 BioPharma Inc. to meet objectives tied to
milestones and royalties; our ability to attract and retain experienced
scientists; and management. We are providing this information as of
October 1, 2009. 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.
Array BioPharma Inc.
Tricia Haugeto, 303-386-1193
thaugeto@arraybiopharma.com
