REDWOOD CITY, Calif., May 17 /PRNewswire/ -- Arginox Pharmaceuticals, Inc. today announced that the 50 percent patient enrollment target has been achieved in its pivotal, phase 3, registration study of tilarginine acetate injection in patients experiencing cardiogenic shock following reperfusion for acute myocardial infarction. Cardiogenic shock is the most common cause of death among patients who are hospitalized with an acute myocardial infarction. The TRIUMPH trial is evaluating the safety and efficacy of tilarginine in reducing 30-day mortality in 658 cardiogenic shock patients at over 130 sites in the U.S., Canada, and Europe.
Previously, an independent Data Safety Monitoring Board (DSMB) reviewed safety data for the first 165 or 25 percent of patients enrolled in the TRIUMPH study and informed Arginox that the trial should be continued without modification. The DSMB will meet again this summer to review both safety and mortality trends when the results from the first 50 percent of enrolled patients have been analyzed.
"Our progress to date with the TRIUMPH study represents a significant accomplishment. TRIUMPH investigators have already enrolled more patients in this study than in any previous study of therapies for cardiogenic shock," said Judith Hochman, M.D., global study chair and clinical chief of cardiology at the New York University School of Medicine. "If the final results from this trial are positive, this therapy could make a significant difference in the lives of patients with cardiogenic shock who currently have a very high risk of mortality despite approved treatments, with few additional therapeutic options available."
"Progression to the half way point of phase 3 development with a potentially life-saving therapy represents a major milestone for Arginox, a company which has been exclusively focused on the flawless execution of the TRIUMPH study," said Robert Terifay, president of Arginox. "The safety findings of the 25 percent enrollment DSMB review give us confidence to invest in our preparation for the commercialization and further development of tilarginine."
About Tilarginine Acetate Injection
Tilarginine is a first-in-class drug that inhibits the production of nitric oxide, a chemical normally found in many cells of the body. A growing body of research suggests that overproduction of nitric oxide inside heart and blood vessel cells following a heart attack may play a critical role in the development of cardiogenic shock. By reducing nitric oxide overproduction, tilarginine has the potential to improve heart function, stabilize the circulation, and reduce mortality.
Tilarginine has received Orphan Drug status by the U.S. Food and Drug Administration and the European Medicines Agency (EMEA).
About Cardiogenic Shock
Cardiogenic shock (CS) is characterized by a decreased pumping ability of the heart that causes tissue hypoperfusion. It most commonly occurs as a direct result of acute myocardial infarction (AMI) or heart attack and is characterized by hypotension, decreased urine output, cool and clammy skin, and altered mental status. The condition can cause circulatory collapse, leading to organ failure and death. Up to 10 percent of heart attack patients who reach the hospital alive -- as many as 150,000-200,000 heart attack victims in North America and Europe each year -- will develop CS. Despite major advances in acute cardiac care that have led to dramatic improvements in heart attack survival overall, a similar benefit has not been realized for CS. Recent research and data from large-scale heart attack registries indicate that the mortality of CS remains 40-50 percent under the best treatment conditions and is frequently much higher. CS is the leading cause of death for patients hospitalized with a heart attack.
A systemic inflammatory response syndrome has been implicated in the pathophysiology of cardiogenic shock. Inflammatory mediators, such as interleukins and TNF-alpha are released in response to large myocardial infarctions. These may account for the expression of inducible nitric oxide synthase (iNOS) in cardiac and vascular tissue. Nitric oxide produced inside these tissues by iNOS can inhibit normal compensatory mechanisms regulating vascular tone and cardiac contraction, resulting in poor perfusion of critical organs, including the myocardium.
About Arginox Pharmaceuticals, Inc.
Arginox Pharmaceuticals is an emerging specialty biopharmaceutical company focusing on the discovery and development of breakthrough drugs for treating hospitalized patients. The company's initial area of research is directed at nitric oxide (NO) which has been shown in Nobel prize-winning research to play a role in a range of physiologic functions. Arginox is leading the way in developing drugs to modulate overproduction of NO, which has been implicated in a range of acute cardiovascular pathologies.
Arginox Pharmaceuticals, Inc.CONTACT: Grendel Burrell of Arginox, +1-650-517-0105, orgburrell@arginox.com
Web site: http://www.arginox.com//
