AtheroGenics Reports Clinical Data on Novel Anti-Inflammatory Anti-Oxidant Agent, AGI-1067, at American Diabetes Association Ann
2008年6月10日 - 10:17PM
Marketwired
ATLANTA, GA today announced that data from its 6,144-patient
ARISE Phase 3 clinical study of AGI-1067 (succinobucol) were
presented at the 68th Scientific Sessions of the American Diabetes
Association (ADA) in San Francisco, California. The ADA's annual
Scientific Sessions meeting is the largest gathering of health care
professionals involved in diabetes research and the delivery of
diabetes care.
Results were reported from the Company's ARISE trial of patients
with cardiovascular disease, approximately one-third of whom had a
previous diagnosis of diabetes. The trial showed that the patients
who did not have diabetes when beginning treatment and assigned to
the AGI-1067 dosage group benefited by a 63% reduction in
progression to new onset diabetes, compared to the patients
receiving placebo. Those patients without diabetes at the beginning
of the trial, but whose tests showed a pre-diabetes state referred
to as impaired fasting glucose, showed a 60% reduction in
progression to diabetes. These findings were presented in a Late
Breaking Clinical Study oral presentation entitled, "Delay in
Progression to Type 2 Diabetes in Patients with Cardiovascular
Disease Treated with a Novel Anti-Inflammatory, Anti-Oxidant,
AGI-1067: Evidence from ARISE" [ADA session number LBCS-01], by
lead author Jean-Claude Tardif, M.D., ARISE Co-Principal
Investigator and Director of Research, Professor of Medicine,
Montreal Heart Institute, University of Montreal.
A poster presentation [Abstract 443-P] by lead author and ARISE
clinical investigator, Eric Klug, M.D., Sunninghill Hospital,
Gauteng, South Africa, highlighted the therapeutic effects of
AGI-1067 in the diabetes patients in ARISE. Clinically significant
improvements in glycemic control were seen over a one year
treatment period with AGI-1067 in patients already taking commonly
used anti-diabetes medications. In an analysis of 2,271 diabetes
patients, 31% more patients on AGI-1067 achieved the ADA goal of
hemoglobin A1c (A1c) below 7 %, compared to placebo. A1c is the
accepted standard for measuring control of blood glucose. Diabetes
patients in the AGI-1067 group experienced an A1c reduction of 0.5%
from a baseline A1c level of 7.2%. The reduction was more
pronounced in patients with higher A1c levels at baseline. AGI-1067
also caused a reduction in insulin resistance, as measured by
changes in HOMA-IR levels, at both one month and 12 months. These
results support the potential benefit of this novel
anti-inflammatory anti-oxidant approach to treating patients with
Type 2 diabetes. Patients receiving AGI-1067 had no significant
increases in edema, weight gain or hypoglycemia.
"The unique mechanism of action and encouraging effects on
glycemic control with AGI-1067, when used in combination with
existing oral anti-diabetic treatments or insulin, support its
potential as a future treatment option for patients," said Russell
M. Medford, M.D., Ph.D., President and Chief Executive Officer of
AtheroGenics. "We are looking forward to gaining additional insight
into AGI-1067's impact on controlling blood sugar when final
results from the ANDES Phase 3 clinical trial of AGI-1067 in
diabetes are available in the third quarter of this year."
AGI-1067 is novel oral drug candidate that is currently in Phase
3 clinical development for the treatment of Type 2 diabetes.
AGI-1067 works by selectively inhibiting signaling pathways that
are activated in response to oxidative stress and pro-inflammatory
stimuli. Oxidative stress and inflammation have been implicated as
playing a key role in the pathogenesis of insulin resistance and
diabetes.
About AtheroGenics
AtheroGenics is focused on the discovery, development and
commercialization of potential drug candidates for the treatment of
chronic inflammatory diseases, including diabetes and coronary
heart disease (atherosclerosis). The Company's lead antioxidant and
anti-inflammatory drug candidate, AGI-1067, is being studied in a
Phase 3 clinical trial known as ANDES (AGI-1067 as a Novel
Anti-Diabetic Agent Evaluation Study), for the treatment of Type 2
diabetes. In addition, the Company has other clinical and
preclinical anti-inflammatory compounds, including AGI-1096, an
oral agent for the prevention of organ transplant rejection. For
more information about AtheroGenics, please visit
http://www.atherogenics.com.
Disclosure Regarding Forward-Looking Statements
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. AtheroGenics cautions investors not to place
undue reliance on the forward-looking statements contained in this
release. These and other 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. For example, additional information relating to
the safety, efficacy or tolerability of AGI-1067, may be discovered
upon further analysis of trial data. The U.S. 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. 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, 2007 and Quarterly
Report on Form 10-Q for the quarter ended March 31, 2008, and 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.
CONTACTS: AtheroGenics, Inc. Mark P. Colonnese Executive Vice
President 678-336-2511 Email Contact Media Inquiries Jayme Maniatis
/ Dana Conti Schwartz Communications, Inc. 781-684-0770 Email
Contact Investor Inquiries Lilian Stern Stern Investor Relations,
Inc. 212-362-1200 Email Contact
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