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Phase 3 Trial Initiated for Tilarginine Acetate, Potential Treatment for Cardiogenic Shock
Up to 10 percent of heart attack patients who reach the hospital alive, or as many as 100,000 U.S. heart attack victims each year, will develop CS. The condition is characterized by circulatory collapse, leading to organ failure and death. 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 patients who experience CS.
"Recent research and data from large-scale heart attack registries indicate that mortality from CS remains 40 percent to 50 percent under the best treatment conditions and is frequently much higher. TRIUMPH will answer an important clinical question in an area of significant unmet medical need," said David Hathaway, M.D., Arginox's chief medical officer.
TRIUMPH (Tilarginine Acetate for Injection in a Randomized International Study in Unstable AMI Patients with Cardiogenic Shock) will evaluate the effectiveness of TAI to reduce all cause mortality in patients with CS. The randomized, double-blind, placebo-controlled trial will enroll approximately 650 patients at over 120 sites in the United States, Canada and Europe. Patients will be randomized to receive either TAI as a bolus and five hour infusion or placebo.
"I'm excited to lead this Phase 3 study that may provide improved treatment options for this critically ill patient population," said Judith Hochman, M.D., director of Cardiovascular Clinical Research and Harold Snyder Family Professor of Cardiology at New York University School of Medicine, and the study's global lead investigator. "Despite major advances in acute cardiac care over the past two decades, the mortality for patients with CS, despite having an open coronary artery, remains unacceptably high."
Dr. Hochman also led SHOCK 2, the Phase 2 dose-ranging study of TAI for the treatment of CS. SHOCK 2 was the first clinical research study of a potential new pharmacologic therapy for CS in more than a decade. TAI was well tolerated in the full cohort of patients tested, including those over 75 years of age. Although the study was not statistically designed to evaluate mortality, it appeared that there was a trend toward lower mortality in patients who were treated with the highest doses of TAI compared to those who received placebo.
"TAI represents a new way to intervene in this condition, and we believe that TRIUMPH is a landmark study that, if successful, could provide a therapy to finally reduce mortality in patients with CS and change the way physicians approach the treatment of these high risk patients," said Ian Gilchrist, M.D., Penn State Milton S. Hershey Medical Center and the principal investigator who enrolled the first patient in the TRIUMPH study. "We know that if patients with CS survive the first 30 days, they are likely to live for many years, and have the same mortality as heart attack patients without CS. We need new therapies to improve early survival."
Tilarginine Acetate Injection (TAI)
TAI 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 following a heart attack may play a critical role in the development of CS. By blocking the production of nitric oxide, TAI has the potential to interrupt the cycle of circulatory shutdown that can quickly lead to death. TAI has received orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of CS.
Source: Arginox Pharmaceuticals