July 29, 1999 14:30
BEXTRA Trial Terminated With No Statistically Significant
Survival Advantage
LEXINGTON, Mass.--(BW HealthWire)--July 29, 1999--Interneuron Pharmaceuticals, Inc.
(NASDAQ:IPIC) today announced that it has been notified that the BEST (Beta-blocker
Evaluation of Survival Trial) trial of BEXTRA(R) (bucindolol) has been terminated at the
recommendation of the BEST Data and Safety Monitoring Board, based upon the absence of
significant survival advantage of treatment with bucindolol.
According to the BEST Coordinating Center, the decision of the Data and Safety Monitoring
Board "was based upon the totality of evidence available regarding beta-blocker treatment of
heart failure from BEST and other randomized controlled trials. There was no significant
survival advantage of treatment with bucindolol for the population as a whole. However, the
results are not inconsistent with those of other studies, specifically MERIT-HF and CIBIS II.
Full results of the study will be forthcoming. For the present, it is recommended that BEST
investigators treat patients comparable to those entered into MERIT-HF or CIBIS-II as
suggested by the results of those studies." MERIT-HF and CIBIS-II were previous studies of
beta-blockers in congestive heart failure.
The BEST Coordinating Center also advised BEST investigators "to conduct the trial and follow
patients in accordance with the study protocol at this time" and said that study closeout
procedures will be sent to investigators next week.
This information is the sum total of information available to Interneuron at this time. Decisions
on sub-group analyses and possible regulatory actions will be pending until more data is made
available to Interneuron.
BEST is co-sponsored by the National Heart, Lung, and Blood Institute (NHLBI), a division of
the National Institutes of Health (NIH), and the Department of Veterans Affairs (VA).
Interneuron owns 65% of CPEC LLC, which is developing BEXTRA for congestive heart failure.
Incara Pharmaceuticals (NASDAQ:INCR), formerly Intercardia, Inc., owns 35% of CPEC LLC.
Interneuron is continuing its other advanced-stage product development programs as planned,
including CerAxon (citicoline) for stroke, pagoclone for panic and generalized anxiety
disorders, and IP-501 for liver disease.
Interneuron Pharmaceuticals is 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 delays in
obtaining the BEST database; 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
CONTACT: Interneuron
Glenn L. Cooper, M.D.
President and Chief Executive Officer
or
William B. Boni
VP, Corp. Communications
(781) 402-3410 |
