Cambridge NeuroScience Initiates Second Phase I Study of CNS 5161 and Announces Successful Completion of First Phase I Trial
October 21, 1997 08:29 AM
CAMBRIDGE, Mass., Oct. 21 /PRNewswire/ -- Cambridge NeuroScience, Inc. CNSI announced today the initiation of a second Phase I study of the ion-channel blocking small molecule CNS 5161, for the treatment of neuropathic pain and migraine. The Company also announced the successful completion of the first Phase I trial for 5161, which began in August. Dosing for the second Phase I study has been initiated.
The completed Phase I trial was conducted at the Western Infirmary associated with the University of Glasgow in Scotland, and tested the safety and pharmacokinetics of CNS 5161 in 32 healthy volunteers. Lead investigator of the trial, Kennedy Lees, M.D., Clinical Director of the Acute Stroke Unit at Western Infirmary, said "this was the first time CNS 5161 was administered to humans and the compound was well tolerated. The results of the first Phase I trial support the safety of the compound as a potential therapeutic for the treatment of neuropathic pain and migraine."
The second Phase I trial will compare the effects of 5161 to those of morphine and placebo, in an accepted model of centrally mediated pain. Six healthy volunteers will each receive two different doses of 5161, a dose of morphine with known action, and placebo. The treatments will be delivered in a double-blind fashion, during four separate sessions and the subject response will be measured using a standard computerized technique.
"We are pleased with the results of the first Phase I trial and have initiated the second Phase I study to further demonstrate the safety and potential efficacy of CNS 5161," commented Elkan R. Gamzu, Ph.D., President and Chief Executive Officer of Cambridge NeuroScience. "We expect to have the results from the second Phase I trial in early 1998."
Animal studies have shown that CNS 5161 can prevent the development of a delayed pain response, which is thought to be related to the development of centrally mediated pain in humans following viral infection, surgery or trauma. Estimates of the potential market for the prevention of neuropathic pain range from 400,000 to 900,000 patients annually in the United States alone. CNS 5161 is a compound belonging to a class of agents called NMDA ion- channel blockers. Clinical experiments on drugs with similar mechanisms of action have demonstrated superiority over morphine in the attenuation of persistent pain.
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.
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 results of the scientific research programs described above, the strategic interests of Cambridge NeuroScience in pursuing the project as well as the results of future 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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