Cambridge Neuroscience Inc. initiated a dose-escalating safety study ofCerestat in traumatic brain injury patients.Previous studies of the NMDA ion-channel blocker involved infusionof the drug for four hours. This trial, which will involve 32 patientswho have suffered severe head injury, will receive up to a 72-hourinfusion of Cerestat.The idea is that longer treatment will provide more benefit to injuredpatients, said Philip Holberton, chief financial officer of theCambridge, Mass., company. He added that it will help the companyprepare for later pivotal trials.Endpoints include intracranial pressure and cerebral perfusion pressure.Later this year the company plans to start a dose-response/efficacy trialin more than 100 stroke patients."We are simultaneously advancing the clinical development of Cerestatfor both stroke and traumatic brain injury [TBI], and the safety datacontinue to be encouraging," Robert McBurney, the company's seniorvice president and chief scientific officer, said at the BioPartneringEurope Conference in London. "If the drug continues to be welltolerated in this new [TBI] trial and the effects on surrogate endpointsfor clinical activity are confirmed, we plan to initiate a Phase IIIefficacy trial in several hundred TBI patients next year."Cerestat acts to prevent nerve cell death and brain damage bypreventing excessive entry of calcium into nerve cells. _ Jim Shrine
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