Cambridge Stops Cerestat Trial In Brain Injury

There was further disappointment for Cambridge Neuroscience with thenews that it had stopped its Phase III trial of Cerestat (aptiganel) in traumatic brain injury patients because a planned interim analysis of the data showed insufficient evidence of a positive clinical impact.

This was a second blow to the biotechnology company, as Cambridge had already said in June that it was calling a temporary halt to the accrual of new patients into a Phase III trial of Cerestat (aptiganel) in stroke patients (Marketletter June 30). Shares in the company fell almost 60% on that day to close at under $4. After the termination of the TBI trial, the stock has loitered at or near its 52-week low, in the low $2 range. Just over a year ago, the share price had been over $15.

Analysis of the TBI trial data showed that on a wide variety of safety parameters, the drug was safe and well tolerated. Cambridge, in collaboration with its partner Boehringer Ingelheim, says it will continue to collect further data and conduct an in-depth analysis on the 500-plus patients enrolled to date, to document the safety data "for possible future clinical development of the drug."