SAN DIEGO, March 26 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced completion of a Phase I clinical trial in multiple sclerosis (MS) with its lead compound NBI-5788. Neurocrine conducted this study in collaboration with Novartis Pharma AG (Basel, Switzerland) in 30 patients with multiple sclerosis in five medical centers in the United States and Canada. In this study, comprehensive safety assessment, including an assessment of neurologic status and magnetic resonance imaging (MRI) scans of the brain were performed. An independent safety board reviewed clinical safety and MRI data and recommended continued evaluation of the effect of NBI- 5788 in MS patients. Novartis and Neurocrine plan to initiate multinational Phase II trials in patients with relapsing-remitting MS in mid-1997 and progressive MS later in the year. These trials will evaluate the effect of different dose levels of NBI-5788 on clinical, immunologic and MRI outcomes.
In addition, Neurocrine announced the appointment of Stephen G. Marcus, M.D., to the newly created position of Senior Vice President, Clinical and Regulatory Affairs and Chief Medical Officer. In this capacity, Dr. Marcus will be responsible for assisting Neurocrine and its collaborative partners in designing and conducting human clinical studies and additionally will manage the regulatory process for new products.
Throughout his career, Dr. Marcus has been successful in obtaining marketing approvals in the United States, Europe and Canada, has filed many Investigational New Drug (IND) applications and initiated human clinical studies for several immunologic diseases as well as oncology indications including malignant brain tumors. He has extensive experience in immunologic diseases, one of the areas of Neurocrine's primary focus, and was directly responsible for the development and management of clinical research for the pivotal studies leading to the approval of Betaseron for multiple sclerosis (MS). Dr. Marcus, most recently was vice president, clinical and regulatory affairs for Genetic Therapy, Inc., a wholly-owned subsidiary of Novartis, focused on gene therapy. At Genetic Therapy, Inc. Dr. Marcus was responsible for managing the development of the first clinical studies for several gene therapy products, including a gene therapy compound currently in Phase III for malignant brain tumors.
"Dr. Marcus brings to Neurocrine a wealth of experience in clinical research and development of new drugs," said Gary A. Lyons, president and chief executive officer of Neurocrine Biosciences. "We look forward to benefiting from his experience directing clinical development as two of our products enter late stage development for the treatments of MS and Alzheimer's disease. Dr. Marcus' addition to our scientific staff gives Neurocrine additional strength in the area of neurological and immune diseases."
Neurocrine Biosciences is a leading neuroimmunology company focused on the discovery and development of novel therapeutics to treat diseases and disorders of the central nervous and immune system such as anxiety, depression Alzheimer's disease, obesity and multiple sclerosis.
This press release contains certain forward looking statements based upon
current expectations. Actual results could differ materially from those
indicated in the forward looking statements as a result of several factors,
including those factors outlined in "Risk Factors" and elsewhere in the
Company's registration statement in form S-1 and prospectus, dated May 23,
1996, constituting a part thereof.
SOURCE Neurocrine Biosciences, Inc.
CONTACT: Elizabeth Foster or Paul Hawran, both of Neurocrine Biosciences, 619-658-7600