AtheroGenics Forms Steering Committee of Prominent Cardiovascular Experts To Oversee Phase III Clinical Study With AGI-1067 in Atherosclerosis
ATLANTA, Oct. 4 /CNW/ --
AtheroGenics, Inc. (Nasdaq: AGIX), a pharmaceutical company focused on the
treatment of chronic inflammatory diseases, today announced it has formed a
steering committee comprised of some of the most highly regarded
cardiovascular experts in North America to help design and oversee the Phase
III clinical trial with AGI-1067 in atherosclerosis.
The AGI-1067 Steering Committee members include:
* Marc A. Pfeffer, M.D., Ph.D., Steering Committee Co-Chairman,
Cardiologist and Professor of Medicine at Brigham and Women's Hospital,
Harvard Medical School
* Jean-Claude Tardif, M.D., Steering Committee Co-Chairman, Director of
Clinical Research and Associate Professor of Medicine, Montreal Heart
Institute
* Jean Davignon, M.D., Professor, Faculty of Medicine, University of
Montreal; Director, Hyperlipidemia and Atherosclerosis Research Group
* Peter Ganz, M.D., Director of Vascular Research, Brigham and Women's
Hospital, Associate Professor of Medicine, Harvard Medical School
* Steven M. Haffner, M.D., Professor, Department of Medicine, Division of
Clinical Epidemiology at the University of Texas Health Science Center
at San Antonio
* David Harrison, M.D., Professor, Director of Cardiology, Emory
University School of Medicine
* Peter Libby, M.D., Chief of Cardiovascular Medicine at Brigham and
Women's Hospital, Harvard Medical School
* Steven Nissen, M.D., Vice Chairman of the Department of Cardiology at
the Cleveland Clinic Foundation
* Carl J. Pepine, M.D., Professor of Medicine and Chief, Division of
Cardiovascular Medicine, University of Florida, College of Medicine
"Current therapies for atherosclerosis act indirectly by treating risk
factors such as high cholesterol," said Dr. Pfeffer. "AGI-1067 represents a
new and promising class of therapeutics that, if successful in clinical
trials, could signify an important breakthrough by directly targeting the
inflammatory process in the vessel wall."
"Having been involved with AGI-1067's successful Phase II trial, I am
delighted to continue the study of this novel compound that has produced such
compelling data, suggesting it is reversing the progression of
atherosclerosis," said Dr. Tardif. "I look forward to collaborating with the
esteemed group of experts that have been assembled for this Phase III study."
"AtheroGenics believes that having such respected thought-leaders in the
field of cardiology choose to be part of the steering committee represents a
powerful validation of our approach to treating inflammation as the underlying
cause of atherosclerosis," said Rob Scott, M.D., Senior Vice President of
Clinical Development and Regulatory Affairs and Chief Medical Officer at
AtheroGenics. "A systemic therapy that directly targets inflammation may
provide a treatment for all patients with heart disease, whether or not they
have clinical risk factors."
AGI-1067 is a novel, oral anti-inflammatory agent and anti-oxidant that is
being tested as a treatment for the chronic, destructive inflammation of
atherosclerosis. AGI-1067 has been shown to be safe and well tolerated by
patients at all doses tested in the Company's clinical trials to-date. In a
305-patient, six-week Phase II study led by Dr. Tardif, AGI-1067 met its
primary endpoint in reducing post-angioplasty restenosis. In a post-study
analysis, AGI-1067 was shown to have a direct anti-atherosclerotic effect on
coronary blood vessels, consistent with reversing the progression of coronary
artery disease. The Company has initiated a 500-patient, 12 month Phase IIb
clinical trial with AGI-1067 for atherosclerosis and restenosis.
About Atherosclerosis
Atherosclerosis is the leading cause of death in Western societies,
claiming more lives each year than all forms of cancer combined.
Atherosclerosis is a progressive disease of the arteries resulting from
inflammation and the buildup of plaque under the inner lining of the arteries,
causing severe blockage in the blood flow. Depending on the location of the
artery it affects, atherosclerosis may lead to heart attack, stroke or
amputation. Coronary artery disease is the most common, and serious,
consequence of this disease. According to the American Heart Association,
over 12 million Americans suffer from coronary artery disease today and it is
the single largest killer of both men and women. In 1998, coronary artery
disease caused nearly half a million deaths in the United States, or - 1 of
every 5 deaths.
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. The Company has four drug development programs in the clinic.
Protocols are currently being defined for a Phase III program for the
Company's most advanced clinical compound, AGI-1067, as an oral therapy for
atherosclerosis. AGI-1067 is being studied in an ongoing Phase IIb clinical
trial for the treatment of atherosclerosis and post-angioplasty restenosis.
AGIX-4207, the Company's second clinical compound derived from its proprietary
v-protectant technology platform, is a novel, oral agent being tested in a
Phase II clinical program for the treatment of rheumatoid arthritis. AGIX-
4207 I.V. is an intravenous rheumatoid arthritis treatment that has completed
a Phase I clinical study. AGI-1096 is a novel, oral agent that has completed
a Phase I clinical trial for the prevention of organ transplant rejection.
For more information about AtheroGenics, please visit www.atherogenics.com . |
