More MS news articles for December 2000

Neurocrine Biosciences starts anxiety drug Phase 1 trials

http://www.individual.com/browse/story.shtml?story=b1222011.9rg&level1=46610&level2=46618&level3=2917&date=20001227

December 27, 2000
Sanjib Dutta, BridgeNews

New York--Dec. 22--Neurocrine Biosciences Inc. started the Phase I clinical trials of Corticotropin Releasing Factor1, a receptor antagonist compound, in 48 volunteers. Corticotropin is for the treatment of anxiety and depression.

The following is the text of today's announcement with emphasis added by BridgeNews. BridgeStation links to company data have been inserted at the end:

Neurocrine Biosciences Announces Initiation of Phase I Clinical Trial in Anxiety and Depression With Proprietary CRF1 Receptor Antagonist

SAN DIEGO--(BW Healthwire)--Dec. 22, 2000--

Janssen Collaboration Also Moves Forward With CRF1 Development

Compound

NEUROCRINE BIOSCIENCES INC. (NASDAQ:NBIX) TODAY ANNOUNCED THE INITIATION OF A PHASE I CLINICAL TRIAL WITH ITS PROPRIETARY CORTICOTROPIN RELEASING FACTOR1 (CRF1) RECEPTOR ANTAGONIST COMPOUND FOR THE TREATMENT OF ANXIETY AND DEPRESSION.

THIS TRIAL IS BEING CONDUCTED IN 48 NORMAL, HEALTHY VOLUNTEERS AND IS DESIGNED TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS INCLUDING ENDOCRINE PROFILES OVER A RANGE OF ESCALATING DOSES. TO DATE, THE TWO DOSING GROUPS INVOLVING 16 SUBJECTS HAVE COMPLETED TREATMENT AND INITIAL KINETIC EVALUATION INDICATE GOOD AND RAPID ABSORPTION WITH NO OBSERVABLE SIDE EFFECTS OR SAFETY CONCERNS. AFTER SUCCESSFUL COMPLETION OF THIS STUDY IN FEBRUARY, A MULTIPLE DOSE ESCALATING TRIAL WILL BE INITIATED TO FURTHER EVALUATE THE SAFETY AND ENDOCRINE PROFILES OF THIS COMPOUND FOLLOWED BY PHASE II STUDIES IN ANXIETY AND DEPRESSION. WITH THE INITIATION OF THIS TRIAL, NEUROCRINE NOW HAS FIVE CLINICAL DEVELOPMENT PROGRAMS INCLUDING INSOMNIA, MALIGNANT GLIOMA, DIABETES AND MULTIPLE SCLEROSIS WITH TWO ADDITIONAL COMPOUNDS PLANNED TO ENTER NEW PHASE I STUDIES IN 2001.

"Enthusiasm for the utility of CRF receptor antagonist for anxiety and depression has gained significant momentum in the past few years. Early preliminary success with the first generation CRF antagonist has intensified the excitement around this novel mechanism in psychiatry," said Dr. Stan Watson, co-director and senior research scientist at the Mental Health Research Institute at the University of Michigan and member of the Scientific Advisory Board of Neurocrine Biosciences.

IN ADDITION, NEUROCRINE'S PARTNERED CRF RECEPTOR ANTAGONIST COMPOUND (NBI 37582) HAS ACHIEVED AN IMPORTANT MILESTONE AND HAS BEEN NOMINATED FOR FULL SCALE DEVELOPMENT BY PARTNER JANSSEN PHARMACEUTICA (A SUBSIDIARY OF JOHNSON & JOHNSON). NBI 37582 has been advanced to development status and is expected to move into Phase I clinical trials by 3rd Quarter 2001 following completion of GLP (Good Laboratory Practices) and GMP (Good Manufacturing Practices) studies. This will complete the research phase of Neurocrine's collaboration with Janssen Pharmaceutica.

"It is our goal to remain the world leader in the CRF field. We are pleased with the progress we have made with our new second generation CRF receptor antagonist programs this year," said Gary Lyons, president & CEO of Neurocrine. "The Janssen program and our internal proprietary programs represent two independent programs for the discovery and development of novel therapeutics for the treatment of anxiety and depression and demonstrates our commitment to this field. It remains our strategy to advance several proprietary CRF compounds into clinical development so as to select the compound with the best safety and efficacy profile for definitive Phase II trials. Our research in this area has also expanded this year and has demonstrated utility of CRF antagonists in Irritable Bowel Syndrome, pain and neuro-protection."

CRF was first identified and cloned by Neurocrine co-founder, Dr. Wylie Vale, and his colleagues at the Salk Institute. CRF functions as a neurotransmitter in the brain and plays a critical role in coordinating the body's response to stress. The CRF1 receptor subtype largely mediates these effects. In preclinical models, selective CRF1 receptor antagonists block stress-related responses providing further evidence that this novel mechanism may result in improved anti-anxiety and anti-depressant properties. In addition, some data suggests that CRF1 antagonists may have a more rapid onset of action and a reduced side effect profile compared to currently marketed anti-depressants.

Neurocrine Biosciences is a neuroscience based research and development biopharmaceutical company focused on the development of therapeutic products in the areas of anxiety, depression, insomnia, malignant brain tumors, diabetes and multiple sclerosis.

Neurocrine Biosciences Inc. news releases are available through the company's Web site via the Internet at http://www.neurocrine.com

In addition to historical facts, this press release contains forward-looking statements that involve a number of risks and uncertainties. Among the factors that could cause actual results to differ materially from those indicated in the forward looking statements are risks and uncertainties associated with Neurocrine's research and development programs and business and finances including, but not limited to, risks and uncertainties associated with, or arising out of, drug discovery, pre-clinical and clinical development of products including risk that research may not generate development candidates, development candidates will not successfully proceed through early clinical trials or that in later stage clinical trials will not show that they are effective in treating humans; determinations by regulatory and governmental authorities; changes in relationships with strategic partners and dependence upon strategic partners for performance of clinical and commercialization activities under collaborative agreements including potential for any collaboration agreement to be terminated without any product success; uncertainties relating to patent protection and intellectual property rights of third parties; impact of competitive products and technological changes; availability of capital and cost of capital; and other material risks. A more complete description of these risks can be found in the company's Form 10K for the year ended Dec. 31, 1999, as amended, the current form 10Q and its most recent registration statement, as filed with the Securities and Exchange Commission, each of which should be read before making any investment in Neurocrine common stock. Neurocrine undertakes no obligation to update the statements contained in this press release after the date hereof.

CONTACT: Neurocrine Biosciences
Claudia Jones or Paul Hawran, 858/658-7600
 

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