Cortech Inc. announced Monday that it has filed an amendment to its investigational newdrug (IND) application to initiate Phase II trials on its drug Bradycor for treating headtrauma patients.
Initially these studies will measure the effect of Bradycor on intracranial pressureand other measures of brain edema. Bradycor is antagonistic to bradykinin, a peptidemediator produced by the body in response to many forms of tissue injury. Bradykinin cancause low blood pressure, tissue swelling, pain and other symptoms of inflammation.
Cortech of Denver is already in Phase II clinicals with Bradycor in patients withsepsis and systemic inflammatory response syndrome. The company started patient enrollmentin this trial in late January, and intends to study 500 patients overall.
The IND amendment, which Cortech (NASDAQ:CRTQ) submitted to FDA on May 5, covers“the second leg of a five-leg strategy,“ explained David Crossen, the company'spresident and chief executive officer. Under a single IND, Cortech intends to studyBradycor's ability to treat multiple trauma, burns, sepsis, pancreatitis and headinjuries, he said.
-- Jennifer Van Brunt