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Biotech / Medical : CNSI Cambridge Neuroscience

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To: TheSlowLane who wrote (181)	6/24/1997 9:19:00 PM
From: Miljenko Zuanic	of 675

To all: Cerestat success for stroke is under big question!! From the press release it is hard to evaluate what is wrong in the trials: "The company said concerns were raised during an interim analysis of data over the benefit to risk ratio of drug treatment." Are the patients outcome worse in Cerestat arm(s) than in placebo group? Or, the patients outcome are some and only the longer (3 months) follow-up analysis can point for drug benefit (if any)? From Mr. Boni statement: "First, it is possible that an imbalance in the patient groups caused the drug patients to look worse than the placebo patients. An analysis of a larger group, 600 patients vs. 300 patients, is more likely to balance the patient groups," he said, adding that longer follow-up may also favor efficacy of the risk/benefit ratio because benefits become more apparent over time. 7-day follow-up efficiency is measured by NIH Stroke Scale! I do not know from where he got information, but this even look worse than my speculation. Reasons to halt trials can be many. Protocol rules are harsh and this possibility was incorporated in protocol. If 3 months follow-up data confirm drug benefit, than the safety/side effects (obviously the safety is a problem) can be annualized with positive effects and trials will continue. Otherwise trials will discontinue. Bad that company didn't comment on two arms/ two dose! Without additional data it is to early for projection of the failure/success possibility. Things has to cool-down and best will be to contact CNSI. Also, outcome of the TBI trials can't be compared/associated with stroke trials. One thing is clear: For acute CNS disorder (stroke) it will be very hard to develop any successful drug(s). Last two "The Lancet" reported several trials failure for Stroke, and only aspirin has small positive effects. Hope TBI interim data will partially compensate today news. mz

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