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Biotech / Medical : CNSI Cambridge Neuroscience -- Ignore unavailable to you. Want to Upgrade?


To: molemania who wrote (305)12/16/1997 10:54:00 AM
From: TheSlowLane  Respond to of 675
 
Text of the announcement:

Cambridge NeuroScience Will Not Restart Accrual in Stroke Trial

Company Continues to Analyze Data

CAMBRIDGE, Mass., Dec. 16 /PRNewswire/ -- Cambridge NeuroScience, Inc. 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.

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. SOURCE Cambridge NeuroScience, Inc.

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Was it expected? I'm not real surprised. If anyone was still holding out hopes for Cerestat - well, it will prove beyond a doubt that hope does in fact, spring eternal. It's going to be a long road back. I would sell now if I wanted to take the tax loss, but at this point I think I'll just wait...



To: molemania who wrote (305)12/16/1997 1:05:00 PM
From: NeuroInvestment  Read Replies (3) | Respond to of 675
 
While I would have preferred to be wrong, in the October 97 issue of NI I wrote:"we see no reason to expect positive news from the full analysis of the halted stroke study (news due late 4Q). Unfortunately, this signals the death knell for Cerestat as a neuroprotectant."

So there was no surprise in today's news.It would have been a shock to hear otherwise. CN and BI will be sifting through the wreckage to see if there are any subgroups of patients who did show improvement....they may find something, but I am not betting that it will be enough to cause BI to fund another Phase III. NeuroInvestment