Cortech Starts Phase II Brain Trauma Trial

Cortech has begun patient enrollment into a Phase II trial of its bradykinin antagonist Bradycor (CP-0127) in patients with traumatic brain injury, according to Timothy Rodell, executive vice president of operations and product development at the company.

As a bradykinin antagonist, Bradycor is intended to interrupt a series of effects, mediated by bradykinin, which is a major contributor to the pathophysiology of cerebral contusions. Following trauma, an enzymatic cascade involving Factor XII, kallikrein and kininogens is stimulated which results in formation of bradykinin. This factor has a number of activities, including disruption of the blood-brain barrier, neutrophil activation, cytokine production and hypotension. These factors combine to form a vasogenic edematous state in the brain, accompanied by inflammation, which leads to an increase in intracranial pressure and can have dramatic consequences on neurological function.

The new study will enroll 160 patients at about 15 centers in North America. Major endpoints are control of intracranial pressure and outcome as measured by the Glasgow Outcome Score, a commonly used measure of neurological function in traumatic brain injury.