www.fdanews.com/articles/72852-arginox-receives-orphan-drug-designation-for-cardiogenic-shock-drug
Arginox Receives Orphan-Drug Designation for Cardiogenic Shock Drug
May 31, 2005
Arginox Pharmaceuticals has received orphan-drug status from the FDA for Tilarginine Acetate Injection (TAI) for the treatment of cardiogenic shock (CS).
CS is one of the most serious complications of a heart attack and affects up to 10 percent of heart attack patients who reach the hospital alive. TAI is a first-in-class drug that inhibits the production of nitric oxide (NO), a chemical normally found in many cells of the body.
A growing body of research suggests that overproduction of NO following a heart attack might play a critical role in the development of CS. Arginox said it intends to begin enrollment of a Phase III trial of TAI later this month.