AtheroGenics Reports Phase II Clinical Results for
AGI-1067 In Post-Angioplasty Restenosis
Preliminary Analysis Indicates Dose-Related Increase in Luminal Diameter At Six Months
ATLANTA, May 21 /PRNewswire/ -- AtheroGenics, Inc. (Nasdaq: AGIX - news), an emerging pharmaceutical company focused on the
treatment of chronic inflammatory diseases, today announced encouraging preliminary results of a Phase II clinical trial of AGI-1067, an
oral agent for the treatment of restenosis after percutaneous coronary intervention (PCI), a procedure commonly known as
``angioplasty.''
An analysis of the results indicated that six months after angioplasty, the blood vessels of patients who received AGI-1067 had greater
luminal diameters of their coronary arteries than those patients who received placebo. This improvement showed a statistically
significant dose response. At the highest dose of AGI-1067, the increase in the size of the target blood vessel was similar to that
achieved with probucol, the active control drug in CART-1 (Canadian Antioxidant Restenosis Trial), which has been shown in previous
clinical studies to reduce restenosis rates significantly following angioplasty without stent deployment.
An unexpected apparent benefit of drug treatment affected the use of the method typically specified for analyzing primary endpoint in a
restenosis study. Because of this apparent early drug benefit on coronary arteries, AtheroGenics has not yet determined whether
CART-1 met its primary statistical endpoint as pre-specified in the protocol. A full analysis of the safety and efficacy data is underway
and expected to be announced later this year.
There were no deaths or increase in the incidence of serious adverse events when comparing AGI-1067 to placebo. In CART-1, an
important safety issue was whether AGI-1067 would cause a prolongation of the QTc interval, which is an electrophysiological
abnormality of the heart. The study showed that AGI-1067 did not cause QTc prolongation. Conversely, probucol did cause QTc
prolongation in a statistically significant proportion of patients.
``CART-1 results confirm and extend the findings from the MVP clinical study of probucol for the treatment of restenosis, which were
published in the New England Journal of Medicine,'' said Jean-Claude Tardif, M.D., FRCPC, Director of Clinical Research at the
Montreal Heart Institute and Principal Investigator of CART-1. ``In CART-1, AGI-1067 appears to exhibit the benefit of probucol
therapy without the potential shortcomings associated with QTc prolongation.''
This multi-center, randomized, double-blinded, placebo-controlled study, known as CART-1, comprised 305 men and women who were
treated by angioplasty, with or without intracoronary stenting. The study was conducted at five clinical sites in Canada, led by the
Montreal Heart Institute and included four other major cardiovascular teaching hospitals. Prior to angioplasty, patients were
randomized to one of five treatment arms: AGI-1067 doses of either 70 mg, 140 mg or 280 mg, once daily, probucol 500 mg twice daily or
placebo.
``This clinical study represents an important achievement in AtheroGenics' clinical development program,'' said Russell M. Medford,
M.D., Ph.D., President and Chief Executive Officer of AtheroGenics. ``We are all very excited about these statistically significant
results, which are the first demonstration of biological activity of AGI-1067 in patients.''
CART-1 study investigators have submitted abstracts for presentation at the American Heart Association meeting in November 2001.
Schering-Plough Corporation has exclusive worldwide rights to develop and commercialize AGI-1067 and is funding all development
and commercialization costs. Under the license agreement, AtheroGenics receives upfront and milestone payments totaling as much as
$189 million, plus royalties on sales of any approved product covered by the license agreement.
To date, there are no approved drugs for the prevention or treatment of restenosis after angioplasty. Restenosis is the re-narrowing or
reclosure of coronary arteries after angioplasty in patients with coronary artery disease. Angioplasty procedures have been proven to
be very effective in opening clogged arteries and have become widely used by cardiologists. More than one million patients around the
world underwent the procedure last year. Unfortunately, angioplasty induces an inflammatory response that contributes to restenosis
within approximately six months in up to 40 percent of the patients who undergo the procedure.
About AtheroGenics
AtheroGenics is focused on the discovery, development and commercialization of novel drugs for the treatment of chronic
inflammatory diseases such as heart disease (atherosclerosis), rheumatoid arthritis and asthma. The company recently commenced
enrollment in a Phase I clinical study for AGIX-4207, AtheroGenics' second v-protectant clinical candidate, a novel oral agent being
developed for the treatment of the signs and symptoms of rheumatoid arthritis. For more information about AtheroGenics, please visit
www.atherogenics.com .
About Schering-Plough
Schering-Plough Corporation of Kenilworth, N.J., is a research-based company engaged in the discovery, development, manufacturing
and marketing pharmaceutical products worldwide.
This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. Such statements are subject to certain factors, risks and uncertainties that may cause actual results,
events and performance to differ materially from those referred to in such statements. These risks include statements which address
operating performance, events or developments that we expect or anticipate will occur in the future, such as projections about our
future results of operations or our financial condition, our collaborative efforts with Schering-Plough Corporation, the development of
our product candidates, anticipated trends in our business, and other risks that could cause actual results to differ materially. These
risks are discussed in AtheroGenics' Securities and Exchange Commission filings, including the company's registration statement on
Form S-1, Registration No. 333-31140, filed with the SEC, and including but not limited to the risks discussed in AtheroGenics' Form
10-K for fiscal 2000, and our most recent Quarterly Report on Form 10-Q for the quarter ended March 31, 2001, all of which are
incorporated by reference into this press release. These documents may also be examined at public reference facilities maintained by
the SEC or, to the extent filed via EDGAR, accessed through the SEC's web site (http://www.sec.gov ).
SOURCE: AtheroGenics, Inc. |
