Healthcare Industry News:  reperfusion injury 

Biopharmaceuticals Cardiology

 News Release - March 14, 2006

PeriCor Therapeutics Reports Positive Two-Year Mortality Results of Acadesine at the American College of Cardiology's Scientific Session

Adenosine Regulation with Acadesine Improves Two-Year Survival After Reperfusion-induced MI

NEW YORK, March 14 (HSMN NewsFeed) -- PeriCor Therapeutics, Inc. announced today that positive results of its novel cardioprotective agent, acadesine, were reported in an oral presentation by Dennis T. Mangano, Ph.D., M.D. at the American College of Cardiology's (ACC) 55th Scientific Session in Atlanta, GA. The study was funded by the Ischemia Research and Education Foundation, San Bruno, CA and conducted in collaboration with the Multicenter Study of Perioperative Ischemia (McSPI) Research Group.

The study found that among patients undergoing coronary artery bypass graft (CABG) surgery who experienced post-reperfusion myocardial infarction (MI), acadesine significantly reduced two-year mortality by 77% as compared to placebo. The principal benefit, which was observed in the first 30 days following MI, was sustained over the two-year period. This is the first large study to demonstrate prospectively an important reduction in mortality from ischemia/reperfusion injury in any setting of clinical revascularization and this benefit was maintained over two years.

Robert Engler, M.D., one of the original discoverers of the effects of ARA agents, said "The dramatic reduction in death rate by acadesine among myocardial infarction patients suggests that acadesine reduced the severity of infarction. This is the first prospective clinical demonstration of an intervention that effectively reduces reperfusion injury."

In the study of 2698 patients, post-reperfusion MI engendered a significant risk of long-term mortality that was mitigated by acadesine. Perioperative myocardial infarction, which occurred in 100 patients, conferred a 4.2-fold increase in 2-year mortality over patients who did not have an infarction (p<0.001). However, acadesine treatment reduced that mortality by 4.3-fold: from 27.8% (15/54; placebo) to 6.5% (3/46; acadesine) (p=0.006) with the principal benefit occurring over the first 30 days following myocardial infarction. Multivariate analysis confirmed these findings, with no other differences between the groups confounding this relationship.

Commenting on the clinical implications of this study, Dennis T. Mangano, Ph.D, M.D., Chair of PeriCor's Scientific Advisory Board, stated that "Based on the findings of this study, more than 600,000 patients undergoing CABG surgery worldwide each year would be eligible to receive acadesine with the potential of saving thousands of lives annually." Dr. Mangano was the principal investigator of this study and is Principal Scientist of the Ischemia Research & Education Foundation.

The study reported today investigated the effects of acadesine on long- term mortality after perioperative MI. It was prospectively designed to monitor all-cause mortality for two years among those patients enrolled in the acadesine 1024 trial who had suffered MI around the time of their CABG surgery. It was randomized, placebo-controlled, and double-blinded. The original in-hospital Phase IIIa 1024 trial was also double-blinded, placebo- controlled, and randomized. It compared the effects of acadesine and placebo on myocardial infarction, through four days following CABG surgery. The drug was administered intravenously at 0.1 mg/kg/min for seven hours continuously, starting 15 minutes prior to the induction of anesthesia. The study was conducted at 54 institutions in the U.S. and Canada, enrolling 2,698 patients with 1,346 receiving placebo and 1,352 receiving acadesine. Although the original study showed a trend that acadesine reduced the incidence of perioperative MI, the difference was not statistically significant.

Richard R. Stover, President and CEO of PeriCor Therapeutics, Inc., added "The remarkable findings of this study confirm that adenosine regulating agents, of which acadesine is the prototype, represent a potentially unique and effective treatment to protect the heart muscle from ischemia/reperfusion injury."

About Acadesine

Acadesine is an adenosine regulating agent (ARA) which has been shown to amplify the body's broad-spectrum protective response during an ischemic event. By augmenting a patient's own adenosine release in ischemic tissue, acadesine appears to protect heart muscle from ischemic damage. Preclinical studies have shown that ARAs increase endogenous adenosine release in an event-specific and site-specific fashion, remaining pharmacologically silent in the absence of net ATP breakdown.

This novel, first-in-class, cardioprotective compound has been shown to be safe and well tolerated in studies of over 4,000 patients across five key clinical studies in the setting of CABG surgery. The results of the meta- analysis of these studies, performed by Dr. Mangano, were previously published in the Journal of the American Medical Association (JAMA 1997; 277: 325-32).

About PeriCor Therapeutics

PeriCor Therapeutics, Inc. is a privately-held specialty biopharmaceutical company focused on the development and commercialization of a new class of medicines, adenosine regulating agents, to prevent the perioperative complications of surgery and improve the treatment and outcomes of acute cardiovascular care.

Source: PeriCor Therapeutics

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