Published:
AtheroGenics Announces ARISE Phase III Clinical Study Results at the American College of Cardiology's 56th Annual Scientific Session

AtheroGenics, Inc. (NASDAQ: AGIX) today
announced the presentation of its Aggressive Reduction of Inflammation
Stops Events (ARISE) Phase III clinical study of lead drug candidate,
AGI-1067, at the American College of Cardiology's 56th Annual Scientific
Session. While AGI-1067 did not show a difference from placebo in the
composite primary endpoint, the study did achieve a number of other
important predefined endpoints. These endpoints included a reduction in the
composite of "hard" atherosclerotic clinical endpoints, composed of
cardiovascular death, myocardial infarction (heart attack) and stroke, as
well as improvement in the key diabetes parameters of new onset diabetes
and glycemic control.
"The highest bar in clinical research is to improve the prognosis of
patients that are already receiving optimal care," said Marc A. Pfeffer,
M.D., Ph.D., Professor of Medicine, Harvard Medical School; Cardiologist at
Brigham and Women's Hospital and co-principal investigator for the ARISE
trial. "Although the formal primary composite endpoint in ARISE was not
met, we believe that the trial generated strong evidence that use of
AGI-1067 will produce tangible clinical benefits for patients with coronary
artery disease."
ARISE study findings include:
-- Secondary "hard" endpoint -- In a composite of "hard" atherosclerotic
endpoints, composed of cardiovascular death, resuscitated cardiac arrest,
myocardial infarction (heart attack) and stroke, AGI-1067 achieved a
meaningful relative risk reduction of 19 percent (p=0.028). A subgroup
analysis indicated that this result was consistent across important sub-
populations such as: patients with and without diabetes, and men and women.
Furthermore, this result was irrespective of whether patients' baseline
cholesterol (LDL and HDL) levels were above or below target.
-- Diabetes parameters -- Patients in ARISE taking AGI-1067 were 64
percent less likely to develop new onset diabetes (p < 0.0001). In patients
with diabetes, AGI-1067 improved glycemic control as measured by reductions
in HbA1c of 0.5 percent at 12 months (p < 0.0001). These patients had a
mean baseline HbA1c of 7.2 percent.
-- Safety and tolerability -- The most common side effect seen with AGI-
1067 was diarrhea-related; however, it did not frequently result in patient
discontinuation (3.3 percent vs. 0.3 percent). There was a small increase
in the number of patients with abnormal liver function tests as measured by
changes in a combination of liver enzymes and bilirubin (0.2 percent vs.
0.1 percent).
"We are pleased with the meaningful improvement of patient outcomes
observed with AGI-1067 in ARISE, which should help to address the burden of
cardiovascular risk that exists despite our effective contemporary
treatments," said Jean-Claude Tardif, M.D., Director of Research; Professor
of Medicine, Montreal Heart Institute, University of Montreal, and
co-principal investigator of the ARISE trial.
"The ARISE trial has shown that AGI-1067 demonstrated considerable efficacy
in a number of important therapeutic areas, including heart disease and
diabetes," said Rob Scott, M.D., Executive Vice President of Research and
Development and Chief Medical Officer of AtheroGenics. "We look forward to
our upcoming dialog with regulatory experts to discuss the next steps in
the development program for AGI-1067."
"We included a number of endpoints in ARISE to assess the impact of
AGI-1067 on both cardiovascular disease and diabetes as there exists
extensive scientific literature linking oxidative stress and inflammation
to both of these therapeutic areas," said Russell M. Medford, M.D., Ph. D.,
President and Chief Executive Officer of AtheroGenics. "We are encouraged
by the results of ARISE and look forward to continuing development of this
important drug with the goal of improving patient care."
About ARISE
The ARISE trial is a Phase III, double-blind, placebo-controlled trial in
6,144 patients with recent acute coronary syndrome (ACS). The trial was
conducted in 259 cardiac centers in the United States, United Kingdom,
Canada and South Africa. The primary endpoint in the ARISE study was to
compare the effect of AGI-1067 to placebo on the time to first incidence of
a composite of major adverse cardiovascular events (MACE), specifically
cardiovascular death, resuscitated cardiac arrest, myocardial infarction,
stroke, need for coronary revascularization and admission to hospital for
unstable angina. All patients in the study were well treated with the
appropriate standard of care.
About AtheroGenics
AtheroGenics is focused on the discovery, development and commercialization
of novel drugs for the treatment of chronic inflammatory diseases,
including heart disease (atherosclerosis), rheumatoid arthritis and asthma.
In addition to AGI-1067, the Company has another clinical-stage development
program studying AGI-1096, a novel, oral agent in Phase I that is being
developed for the prevention of organ transplant rejection in collaboration
with Astellas. AtheroGenics also has preclinical programs in rheumatoid
arthritis and asthma utilizing its proprietary vascular protectant®
technology. For more information about AtheroGenics, please visit
http://www.atherogenics.com.
Disclosure Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve
significant risks and uncertainties, including preliminary summary
statements relating to the analysis of AtheroGenics' ARISE study for
AGI-1067 and preliminary summary statements relating to the potential
efficacy and safety profile of AGI-1067. These and other statements
contained in this press release that relate to events or developments that
we expect or anticipate will occur in the future are deemed to be
forward-looking statements, and can be identified by words such as
"believes," "intends," "expects" and similar expressions. Such statements
are subject to certain factors, risks and uncertainties that may cause
actual results, events and performances to differ materially from those
referred to in such statements. AtheroGenics cautions investors not to
place undue reliance on the forward-looking statements contained in this
release. The preliminary results discussed in this release may not be
confirmed upon full analysis of the detailed results of the ARISE study and
additional information relating to the safety, efficacy or tolerability of
AGI-1067, may be discovered upon further analysis of trial data. In
addition, our
forward-looking statements are subject to a number of factors that could
cause actual outcomes to differ materially from those expressed or implied
in our forward-looking statements, including that the Food and Drug
Administration might not allow us to conduct further studies of the
efficacy of AGI-1067 for the same or new endpoints, and, to the extent
approved, additional clinical trial work may take a significant period of
time to complete or require significant additional resources to complete,
or that AstraZeneca could terminate its collaboration agreement with us
based on the results of the clinical trial. We cannot ensure that AGI-1067
will ever be approved or be proven safe and effective for use in humans.
These and other risks are discussed in AtheroGenics' Securities and
Exchange Commission filings, including, but not limited to, the risks
discussed in AtheroGenics' Annual Report on Form 10-K for the fiscal year
ended December 31, 2006. The risk factors regarding AtheroGenics that are
included under the caption "Risk Factors" in AtheroGenics' Annual Report on
Form 10-K for the fiscal year ended December 31, 2006 are specifically
incorporated by reference into this press release. We undertake no
obligation to publicly update any forward-looking statement, whether as a
result of new information, future events, or otherwise.
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