BiotechTracker - ReoPro for Stroke
May 28, 2003 New data analysis from a phase II clinical trial in the management of acute ischemic stroke validates phase III investigation of Johnson & Johnson (NYSE: JNJ) and Eli Lilly’s (NYSE: LLY) ReoPro (abciximab) in this clinical setting. ReoPro and other glycoprotein (gp) IIb/IIIa inhibitors need to demonstrate more compelling evidence of long-term antithrombotic benefit to sustain their market, given recent evidence of a suspect risk-benefit profile in real-world (as opposed to clinical trial) patients with acute coronary syndromes undergoing percutaneous coronary intervention. Acute ischemic stroke is a viable indication for ReoPro and other gp IIb/IIIa inhibitors given the condition’s lack of pharmacological responsiveness.  At the European Stroke Conference in Valencia, Spain on Friday, Professor Werner Hacke (University Clinic, Heidelberg, Germany) reiterated earlier findings from the Abciximab in Emergent Stroke Treatment Trial (AbESTT) trial (see BT Reports, February 18, 2003), providing confirmatory evidence of ReoPro’s ability to contribute to a statistically significant functional response for less severely affected patients. Furthermore, a presentation by a Spanish group suggests that ReoPro administration within 5, rather than 6, hours of stroke onset contributes to more desirable clinical outcomes.  In AbESTT, more than 90% of the study subjects were treated between 3 and 6 hours of symptom onset because virtually all patients that arrive for therapy within 0 to 3 hours are given tPA (such as Genentech’s [NYSE: DNA] Activase), the thrombolytic of choice in early, ischemic stroke.  Earlier trends toward improved functional outcomes with ReoPro in the 3-to-6 hour time frame are now supplemented with statistically significant secondary endpoint achievements based on outcomes measured by a different tool, the modified form of the Rankin Scale. Essentially, this tool controls for the initial severity of stroke symptoms, and in so doing suggests that a phase III program tailored to demonstrating ReoPro’s benefits to risk-stratified, as opposed to general, populations could be successful.  The second group’s finding that administration of ReoPro between 3 to 5 hours, as opposed to 5 to 6 hours, provides a statistically significant functional advantage should also be considered in the phase III trial design and analysis. 53.9% of those receiving ReoPro within 5 hours of the symptom onset achieved desirable modified Rankin scores versus 34.6% for placebo recipients (p = 0.013).  Investigators have indicated that the modified Rankin scale will be the primary endpoint of the next trial, and researchers will prospectively assess study subjects treated within 5 hours of symptom onset.
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