Activase Shows Promise In Stroke; Filing Set For 1996?

Genentech plans to submit an application to market its recombinant tissue plasminogen activator product Activase (alteplase) as a treatment for ischemic stroke in the USA later this year. The moves follows the publication of positive results of a Phase III study in the New England Journal of Medicine (December 14, 1995).

The concept of using thrombolytics in the treatment of stroke is not new, having first been mooted in the 1950s, but development in this direction has been limited by the associated risks of intracranial hemorrhage. Now, widespread experience in the use of agents such as t-PA, a growing knowledge of the mechanisms underlying the disorder and improved patient-monitoring technology have opened the way for this approach to be tried once again.

The new study was conducted by the US National Institute of Neurological Disorders and Stroke. All 624 patients enrolled into the study received treatment with t-PA (0.9mg/kg given by bolus and 60-minute infusion) or placebo within three hours of the onset of stroke symptoms. The patients were given a CT scan to rule out hemorrhagic stroke. The study was divided into two parts; Part 1 tested whether t-PA had clinical activity on the resolution of neurological deficits or symptoms on the National Institutes of Health stroke scale at 24 hours, while Part 2 looked at clinical outcomes at three months, measured by a range of scales.