Combined Treatment With Citicoline and TPA Shows Synergistic Benefit in Reducing Stroke Infarct Volume in Animals.

LEXINGTON, Mass.--(BW HealthWire)--July 7, 1999--

Research published in the most recent issue of Stroke (July 1999) demonstrates a synergistic effect of citicoline and rtPA (recombinant tissue plasminogen activator) in reducing infarct size in an animal model of stroke. Citicoline is currently in late Phase 3 clinical testing for the treatment of stroke by Interneuron Pharmaceuticals, Inc. (NASDAQ:IPIC).

The study, conducted by a team of researchers at the Neurovascular Research Laboratory and Copenhagen University in Denmark and partially sponsored by Interneuron, included a control group and five different groups of rats that were treated with citicoline, rtPA or combinations of these two agents.

Results showed that citicoline alone produced a dose-related reduction in infarct volume. Pooled data from the citicoline alone-treated animals showed a 49 percent reduction in infarct volume (p less than or equal to 0.05). Median infarct volume was reduced 65 percent when citicoline was combined with rtPA (p less than or equal to 0.02).

Total infarct volume was highly correlated to improved functional recovery as measured by the Bederson score, an animal neurological outcome scale (r = 0.686, p less than 0.001). Groups treated with 500 mg/kg of citicoline alone and citicoline combined with rtPA appeared to improve more quickly.

Researchers concluded that these findings provide a basis for the further investigation of the effects of citicoline combined with rtPA for the treatment of ischemic stroke and that the demonstration of functional recovery promoted by this combination suggests its potential clinical benefit.

"These findings have relevance given the availability of rtPA," said Bobby W. Sandage, Jr., Ph.D., executive vice president of research and development at Interneuron. "A future clinical study in ischemic stroke to determine the efficacy of the citicoline-rtPA combination may be appropriate, particularly with respect to evaluating dosage amounts and the time window to treatment initiation following stroke."

Citicoline is currently being tested under the trade name CerAxon(TM) in a 900-patient Phase 3 clinical trial at more than 180 hospitals in the United States and Canada. This trial is expected to conclude in late calendar year 1999.

Interneuron Pharmaceuticals and its majority-owned subsidiary, Intercardia, Inc. (Nasdaq:ITRC) are engaged in the development and commercialization of a portfolio of products and product candidates for central nervous system, cardiovascular and other disorders, including multiple compounds in late-stage clinical development.

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