Bad News For Biotech As Cerestat Trial Suspended

There was further upset in the biotechnology sector on June 24 asCambridge Neuroscience and its partner Boehringer Ingelheim announced that they were calling a temporary halt to the accrual of new patients into their Phase III trial of Cerestat (aptiganel) in stroke patients. Shares in Cambridge Neuroscience fell by 59% on the day of the announcement to close at under $4. The stock had been as high as $14 in February.

Cerestat, a non-competitive glutamate (NMDA) receptor ion channel blocker, is leading the field among the excitatory amino acid antagonists as treatments for stroke and head injury.

The suspension came after a scheduled interim analysis of data from 368 patients in the trial, randomized to three groups (receiving placebo or one of two doses of the drug) who had completed seven-day post-treatment follow-up. During this review, concerns were raised over the risk-benefit ratio of drug treatment. Cambridge and Boehringer Ingelheim insist that the trial has not yet been abandoned, but say they now plan to collect further information and conduct an expanded risk-benefit analysis, on all of the approximately 600 patients enrolled to date, in order to assess clinical improvement and safety.