Cambridge NeuroScience Inc. reported Phase II dataSunday showing non-weight-adjusted doses of Cerestatproduced desired plasma levels of the neuroprotectiveagent in traumatic brain injury patients.
With that information, the Cambridge, Mass., company isplanning to go into Phase III trials by the end of the year,Robert McBurney, the company's chief scientific officer,said Monday. The fixed Phase II dosing regimen was aninitial 15 mg bolus of Cerestat followed by 3 mg of drugdelivered intravenously every hour for 72 hours, for atotal of 231 mg of Cerestat.
"From everything we know in animal studies, the plasmalevel that you can achieve is a good indicator of whetherthe drug will be a good neuroprotector or not, and weachieved three times the level associated withneuroprotection in animals," McBurney said.
The Phase III study is expected to involve 600 to 800patients at some 70 centers in the U.S. and Europe,McBurney said. The endpoint will be outcomes asmeasured by a five-point scale called the GlasgowOutcome Scale.
Cambridge NeuroScience, along with its Cerestat partner,Germany-based Boehringer Ingelheim GmbH, also isdeveloping it for stroke. In that indication, patientenrollment was just completed in a 120-patient Phase IIdose-response trial.
Cerestat is a N-Methyl-D-Aspartate inhibitor designed toprevent nerve cell death and brain damage by preventingexcessive entry of calcium into nerve cells.
McBurney said fixed doses of the drug could be a benefitin a number of areas, such as reducing the opportunity foradministration errors, helping in marketing, and beingeasier to use in emergency clinical situations.
Boehringer Ingelheim, which already paid $15 million toCambridge NeuroScience when the deal closed, also isfunding 75 percent of development costs in the U.S. andEurope, and 10 percent in Japan. The companies willjointly develop and promote Cerestat in the U.S.
Cambridge NeuroScience's stock (NASDAQ:CNSI)closed Monday at $9.25, down 25 cents. n
-- Jim Shrine
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