Interneuron Pharmaceuticals Inc. said Tuesday preliminary results ofa Phase III study of citicoline showed the molecule demonstratedstatistically significant improvement in the recovery of ischemicstroke patients when compared to placebo.
The double-blind, placebo-controlled study in 259 patients involvedthree doses of citicoline and placebo. The primary efficacy outcomescale was improved neurologic function at 12 weeks as assessed bythe Barthel Index, a measurement of stroke symptoms and functionalabilities.
Patients given 500 mg of citicoline, the lowest of three doses, weremore than twice as likely to manifest limited or no disability at 12weeks following stroke as measured by the NIH Stroke Scale, and 1.6times as likely to manifest minimal or no disability as measured bythe Barthel Index, the company said. There was no difference inmortality among the four groups.
Complete findings from the study are scheduled to be presentedMarch 28, 1996, in San Francisco at the 48th Annual Meeting of theAmerican Academy of Neurology.
William Boni, vice president of corporate communications forLexington, Mass.-based Interneuron, said the regulatory strategygoing forward has yet to be determined. "The full range of options isopen, from potential filing to doing further studies," he said.
"At this point it is most likely that we will do another study no matterwhat happens" after review of the data with the FDA, Boni said. Thatstudy would be in stroke, and probably use the 500 mg dose, he said.
Citicoline is believed to limit the immediate damage caused by strokeby preventing the accumulation of toxic free fatty acids. "It has whatwe think is a neuronal repair mechanism," Boni said.
He said an advantage of the oral drug is the 24-hour post-strokewindow of opportunity as opposed to acutely administered drugs thathave shown promise when given within three hours.
Interneuron's stock (NASDAQ:IPIC) gained 13 percent, or $3.63,Tuesday to close at $32.13. _ Jim Shrine
-- Jim Shrine
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