Printer Friendly


 Additional Patients to be Treated at Higher Dose Levels;
 Original Safety Study Completed
 CAMBRIDGE, Mass., Dec. 9 /PRNewswire/ -- Cambridge NeuroScience, Inc. (NASDAQ: CNSI) today announced that based on the encouraging safety profile emerging from the initial Phase I studies of Cerestat for the treatment of stroke patients, the company is expanding the clinical trials of the drug in order to treat more patients and to administer higher doses. Preliminary results from the original multi-center Phase I trial, completed ahead of schedule, demonstrated that Cerestat is well- tolerated by patients who have experienced an acute ischemic stroke. Enrollment for the expanded portion of the trial is now underway.
 According to Dr. Michael Pessin, director, Stroke Service, New England Medical Center, one of the clinical investigators, "We are impressed by how well the drug is tolerated by patients to date -- particularly those patients treated at dosing levels which are believed to be neuroprotective. Expanding the study will provide more information on the safety of Cerestat in this population, prior to initiating large-scale efficacy trials."
 "Cerestat reaches the brain rapidly, a crucial attribute for achieving optimal benefit in these patients," said Elkan Gamzu, Ph.D., president and chief operating officer of Cambridge NeuroScience. "We are particularly pleased by how rapidly the clinical development program for Cerestat has advanced in a medical area for which no effective treatments currently exist."
 Dr. Gamzu noted that data from the entire Phase I trial will be readied for publication following the completion of this expanded portion of the study. Phase II studies of Cerestat in stroke patients are expected to begin in early 1994.
 Cerestat, an NMDA ion-channel blocker, acts to prevent nerve cell death and brain damage following stroke by preventing excessive entry of calcium into nerve cells. It is known that nerve cell death following a stroke is triggered by excessive glutamate released from damaged nerve terminals, which stimulates the massive entry of calcium into nerve cells. There are approximately 500,000 victims of stroke in the United States annually. No effective drug therapy is available to treat these patients, or to prevent the nerve damage that occurs subsequent to a stroke.
 Cerestat is also currently in development as a treatment for severe traumatic brain injury (TBI). Phase I trials designed to assess the safety and dosing regimen of the drug in brain injured patients are underway at The University of Texas Medical School at Houston and the University of Glasgow, Scotland. Phase II trials in this patient population are also planned for 1994. Approximately 500,000 people suffer TBI each year, accounting for the death of between 75,000 and 100,000 Americans annually.
 New England Medical Center, the principal teaching hospital for Tufts University School of Medicine, is a 539-bed tertiary care and referral facility that provides care to more than 17,000 patients annually. Also part of New England Medical Center is the Floating Hospital for Children, a 129-bed full service pediatric hospital. Founded in 1796 as the Boston Dispensary, New England Medical Center has a distinguished history of achievement in scientific research and offers comprehensive inpatient and outpatient care for adults and children.
 Cambridge NeuroScience is a leading neuroscience company engaged in the discovery and development of proprietary pharmaceuticals with a focus on nerve cell survival. The company is developing a number of products to treat stroke, traumatic brain injury, schizophrenia and chronic neurodegenerative disorders such as diabetic peripheral neuropathy and multiple sclerosis.
 -0- 12/9/93
 /CONTACT: Elkan Gamzu, Ph.D., president and COO of Cambridge NeuroScience, 617-225-0600; or Chris Taylor, account executive of Feinstein Partners, 617-577-8110; or Dinah Vaprin, associate director, Public Relations of New England Medical Center, 617-956-0200/

CO: Cambridge NeuroScience, Inc. ST: Massachusetts IN: MTC SU:

CM-JL -- NE005 -- 2196 12/09/93 12:05 EST
COPYRIGHT 1993 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1993 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Dec 9, 1993

Terms of use | Copyright © 2017 Farlex, Inc. | Feedback | For webmasters