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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported):
DECEMBER 16, 1997
CAMBRIDGE NEUROSCIENCE, INC.
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(Exact name of registrant as specified in its charter)
DELAWARE 0-19193 13-3319074
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(State or other (Commission (IRS Employer
jurisdiction of File Number) Identification No.)
incorporation)
ONE KENDALL SQUARE, BUILDING 700, CAMBRIDGE, MA 02139
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (617) 225-0600
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Total Number of Pages 6.
Exhibit Index at Page 4.
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ITEM 5 - OTHER EVENTS
On December 16, 1997, Cambridge NeuroScience, Inc. (the "Company") issued a
news release announcing that the Phase III clinical trial of CERESTAT(1) in
stroke patients, which was temporarily suspended in June 1997, will not restart.
The information contained in this news release is incorporated herein by
reference and filed as Exhibit 99.6 hereto.
ITEM 7 - FINANCIAL STATEMENTS AND EXHIBITS
(c) Exhibits.
99.6 The Company's News Release dated December 16, 1997.
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(1) CERESTAT is a registered trademark of Boehringer Ingelheim International
GmbH.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
CAMBRIDGE NEUROSCIENCE, INC.
Date: December 16, 1997 /s/ Harry W. Wilcox, III
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Harry W. Wilcox, III
Sr. Vice President, Finance and Business
Development; Chief Financial Officer
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EXHIBIT INDEX
Exhibit
Sequential
Number Description
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99.6 The Company's News Release dated December 16, 1997.
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CONTACTS:
Elkan R. Gamzu Theresa McNeely
President and CEO Manager
Cambridge NeuroScience, Inc. Feinstein Kean Partners Inc.
(617) 225-0600 ext. 116 (617) 577-8110
FOR IMMEDIATE RELEASE
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CAMBRIDGE NEUROSCIENCE WILL NOT RESTART
ACCRUAL IN STROKE TRIAL
-- COMPANY CONTINUES TO ANALYZE DATA --
CAMBRIDGE, MASSACHUSETTS, DECEMBER 16, 1997 -- Cambridge NeuroScience, Inc.
(Nasdaq: CNSI) and its partner Boehringer Ingelheim today announced that they
will not resume accrual of new patients into their Phase III trial of
CERESTAT(R) in stroke patients. The decision follows a second interim analysis
of the data on 628 patients who had been enrolled prior to the temporary
suspension of accrual in June 1997. The preliminary analysis of the data
indicated that continuation of the trial is not justified. The plan is now to
further evaluate the data before making any decisions about the future
development of CERESTAT.
"While we are disappointed by the termination of this stroke trial, we are
committed to fully assessing the effects of CERESTAT from both the stroke trial
and the traumatic brain injury trial. We are still collecting data in the latter
trial and will conduct the analysis as soon as the database is finalized," said
Elkan R. Gamzu, Ph.D., President and Chief Executive Officer of Cambridge
NeuroScience, Inc. "We continue to be pleased with the progress of our other
programs and corporate partnering effort. The second clinical trial of CNS-5161,
our compound targeted against neuropathic pain, is near completion and we hope
to have data soon. In addition, we are seeing progress in all of our Growth
Factor programs."
Cambridge NeuroScience, Inc. is a leading neuroscience company engaged in the
discovery and development of proprietary pharmaceuticals focusing on nerve cell
survival. The Company is developing a number of products to treat stroke,
traumatic brain injury and chronic neurodegenerative disorders such as multiple
sclerosis, peripheral neuropathies and other degenerative diseases.
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Boehringer Ingelheim, with headquarters in Ingelheim, Germany, is an
international R&D-oriented pharmaceutical company with total worldwide sales of
more than 7.0 billion Deutschemarks ($4.4 billion U.S.). Boehringer Ingelheim
spent 1.1 billion Deutschemarks ($750 million U.S.) last year on R&D, focusing
on innovative products for the treatment of acute chronic conditions associated
with respiratory, cardiovascular, CNS and gastrointestinal disorders. The
headquarters for the U.S. operations, Boehringer Ingelheim Pharmaceuticals,
Inc., is located in Ridgefield, Connecticut.
This press release contains forward-looking statements based on the current
expectations of management. There are certain important factors that could cause
results to differ from those anticipated by the statements made above,
including, but not limited to, the continued funding of the Company's
development program from Boehringer Ingelheim under the Boehringer Ingelheim
collaborative agreement, the rate of enrollment of patients in the Company's
current and future clinical trials, the results of clinical trials, and the
acceptance by regulatory authorities of the Company's clinical trial outcomes as
a basis for marketing approval.
