**********NEWS!******************
July 07, 1999 09:18
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.
Except for the descriptions of historical facts contained herein, this press
release contains forward-looking statements that involve risks and uncertainties
that could cause the Company's actual results and financial condition to differ
materially from those anticipated by the forward looking statements. These
risks and uncertainties are set forth in the Company's filings under the
Securities Act of 1933 and the Securities Exchange Act of 1934 under "Risk
Factors" and elsewhere, and include, but are not limited to, risks relating to the
Redux-related litigation, including risk relating to the finalization of the proposed
settlement of the product liability litigation; uncertainties relating to clinical
trials and regulatory approvals; need for additional funds and corporate partners;
history of operating losses and expectation of future losses; product liability;
dependence on third parties for manufacturing and marketing; the early stage of
products under development; government regulation, patent risks and
competition.
CONTACT: Interneuron Pharmaceuticals, Inc.
Bobby W. Sandage, Jr., Ph.D.
Executive VP, Research and Development
(781) 402-3406
or
William B. Boni
VP, Corp. Communications
(781) 402-3410
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