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Contact:
Harry W. Wilcox Pamela S. DeMala
Sr. VP Business Development and CFO Director, Public Affairs
Cambridge NeuroScience, Inc. Boehringer Ingelheim
(617) 225-0600 ext. 119 (203) 798-4700
Michelle L. Linn
Manager
Feinstein Partners Inc.
(617) 577-8110
FOR IMMEDIATE RELEASE
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CAMBRIDGE NEUROSCIENCE AND BOEHRINGER INGELHEIM INITIATE PIVOTAL TRIAL OF
CERESTAT(1) IN STROKE
- SECOND PIVOTAL TRIAL OF CERESTAT INITIATED THIS YEAR -
CAMBRIDGE, MASSACHUSETTS, JULY 16, 1996 -- Cambridge NeuroScience, Inc.
(Nasdaq: CNSI) and its partner Boehringer Ingelheim announced today that they
have initiated a pivotal trial of the efficacy of CERESTAT- in stroke patients.
This international trial is planned to enroll 900 patients and will compare two
doses of CERESTAT to placebo in patients who have had a stroke within the prior
six hours. This is the second pivotal trial of CERESTAT to begin in 1996, and
the second indication for which efficacy is being assessed. Earlier this year
the partners initiated a Phase III trial of CERESTAT in 700 patients with
traumatic brain injury. The stroke trial, which is being managed by Boehringer
Ingelheim, will be conducted at approximately 100 sites in the United States,
Canada, Australia, and South Africa.
Cambridge NeuroScience and Boehringer Ingelheim entered into a
collaboration in March of 1995 to jointly develop CERESTAT for stroke and
traumatic brain injury. Under the terms of the collaborative agreement,
Boehringer Ingelheim pays for at least 75% of the development costs and has
exclusive marketing rights, subject to a royalty. Cambridge NeuroScience has the
right to co-promote the product in the United States.
"If the trials of CERESTAT are successful, it will be a significant step
forward in our ability to treat patients who have had a stroke or traumatic
brain injury," said Joseph Martin, M.D., Ph.D., Professor of Neurology,
Chancellor of the University of California San Francisco and a member of the
Board of Directors of Cambridge NeuroScience. "This trial will give us important
information regarding the ability of drugs of this type to reduce the
devastating brain damage caused to patients who have suffered a stroke."
Over 450 patients and volunteers have participated in CERESTAT clinical
trials over the last three years, including more than 350 treated with CERESTAT.
It is known that nerve cell death following a serious head injury or stroke is
triggered by excessive glutamate released from damaged
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nerve terminals which stimulates the massive entry of calcium into nerve cells.
CERESTAT is designed to prevent nerve cell death and brain damage following head
injury or stroke by preventing the excessive entry of calcium into nerve cells.
There are approximately 500,000 victims of stroke in the United States annually.
Recently, Genentech's Activase(2) received FDA approval for the treatment
of patients with occlusive stroke, if they can be assessed by CT or MRI and
treated within 3 hours of the stroke. Activase is a thrombolytic agent that can
dissolve blood clots. Besides Activase, no other effective drug therapy is
available to prevent the nerve cell damage that occurs subsequent to a stroke or
traumatic brain injury. Boehringer Ingelheim and Cambridge NeuroScience believe
that approval of Activase should result in increased awareness of the
availability of stroke treatments and therefore result in a higher percentage of
patients being eligible for all stroke clinical trials, including the CERESTAT
trial.
"The initiation of a second pivotal trial in less than six months is an
impressive accomplishment," according to Elkan Gamzu, President and Chief
Executive Officer of Cambridge NeuroScience. "I am very pleased that with our
partner Boehringer Ingelheim, in the first half of the year, we have been able
to start two trials that will involve more than 1,500 patients."
According to Dr. Andreas Barner, Head of Corporate Medicine at Boehringer
Ingelheim, "This achievement demonstrates that by working together the two
companies have demonstrated considerable progress in the development of
CERESTAT, both preclinically and clinically, and that the partnership with
Cambridge NeuroScience adds value to our central nervous system research."
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
neuropathies, multiple sclerosis and other degenerative diseases.
Boehringer Ingelheim, with headquarters in Ingelheim, Germany, is an
international R&D-oriented pharmaceutical company with total worldwide sales of
6.5 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 Corporation, 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, and the acceptance by regulatory authorities
of the Company's clinical trial outcomes as a basis for marketing approval.
(1) CERESTAT is a registered trademark of Boehringer Ingelheim International
GmbH.
(2) Activase is a registered trademark of Genentech, Inc.
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