Release Details

SAN DIEGO, June 8 /PRNewswire/ -- Neurocrine Biosciences, Inc. (Nasdaq: NBIX) today announced that data from a Phase I/II study of IL-4 Fusion Toxin (NBI-3001) in patients with glioblastoma (malignant brain tumors) were presented at The 50th Annual Meeting of the German Society of Neurosurgery in Munich, Germany. While the Phase I/II study with NBI-3001 was only designed to measure drug safety, the patient MRI scans demonstrated dramatic changes, suggestive of tumor necrosis (cell death) in major portions of the malignant brain tumors. In addition, the results presented showed that dose limiting toxicities have not been identified in this study.

Dr. Friedrich Weber, principal investigator of the European clinical program for NBI-3001 who presented the data at the neurosurgeon's meeting commented, "We saw dramatic changes on MRI scans, showing evidence of acute destruction of major portions of the tumor. These results are encouraging and we will follow these patients to look for evidence of extended progression-free survival or other signs of therapeutic activity."

"This new agent may prove to be a powerful treatment for one of the most aggressive forms of brain cancer for which there is limited treatment and the average survival rate is less than one year. These positive results support Neurocrine's decision to pursue an accelerated clinical development strategy. We expect to initiate expanded randomized pivotal trials in early 2000," said Stephen G. Marcus, M.D., Senior Vice President of Clinical and Regulatory Affairs and Chief Medical Officer.

Neurocrine is currently conducting the advanced safety and efficacy portion of the Phase I/II clinical trial with NBI-3001 in patients with malignant brain tumors. This trial, being conducted at 10 centers in the U.S. and Germany, is expected to complete by year-end 1999.

Preclinical data suggest that when infused directly into the glioblastoma, IL-4 Fusion Toxin kills the tumor cells but not the healthy brain cells. IL-4 Fusion Toxin is a protein in which a blood cell derived growth factor (IL-4) has been joined with a Pseudomonas exotoxin, a potent toxin that can destroy cancer cells. IL-4 has very high affinity for-IL-4 receptors, which are highly localized on malignant brain tumors, but do not exist, on normal brain cells. IL-4 binds tightly to the IL-4 receptors on the surface of the glioblastoma cells and delivers the exotoxin directly into the cell, resulting in cell death. IL-4 Fusion Toxin is administered via a special catheter that permits delivery directly into the brain tumor.

IL-4 Fusion Toxin was discovered and developed by Dr. Raj Puri from the Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration (FDA) in collaboration with Drs. Ira Pastan and Robert Kreitman from the Laboratory of Molecular Biology of the National Institutes of Health (NIH). Neurocrine Biosciences licensed exclusive worldwide rights to IL-4 Fusion Toxin in May 1998.

Including this program, Neurocrine has five programs in clinical development. The Company's CRF receptor antagonist is currently in Phase II clinical development with its partner, Janssen Pharmaceutica, for anxiety/depression. Neurocrine and its partner, Novartis Pharmaceuticals, are conducting their second Phase II clinical trial with Neurocrine's APL compound in patients with multiple sclerosis. Neurocrine is also conducting a Phase II trial with NBI-34060 for insomnia and has commenced a Phase I trial with a second APL compound (NBI-6024) for diabetes.

Neurocrine Biosciences is a leading neuroscience company focused on the discovery and development of novel therapeutics for neuropsychiatric, neuroinflammatory and neurodegenerative diseases and disorders. The Company's neuroscience, endocrine and immunology disciplines provide a unique biological understanding of the molecular interaction between central nervous, immune and endocrine systems for the development of therapeutic interventions for anxiety, depression, Alzheimer's disease, insomnia, stroke, malignant brain tumors, multiple sclerosis, obesity and diabetes.

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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 December 31, 1998 and the current form 10Q 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.
SOURCE Neurocrine Biosciences, Inc.
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