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| |  AAN: Patients With Peritumoral Brain Edema Improve With Xerecept (Human Corticotropin-Releasing Factor) RICHMOND, CA -- May 10, 2000 -- The results of a Phase II trial of Xerecept(TM) (human corticotropin-releasing factor (hCRF)) in patients with peritumoral brain edema were presented by Dr. Subramanian Hariharan, Director of Neuro-Oncology at JFK Neuroscience Institute, at the annual meeting of the American Academy of Neurology held in San Diego April 30-May 5. In a randomized, double-blind, positive-controlled, triple dummy, dose-ranging study conducted by Neurobiological Technologies, Inc. (NTI(R)) in which two different doses of hCRF and a dexamethasone control group were compared, responders were found in the hCRF groups only. The primary neurologic evaluations were significantly improved in the higher dose, 1mg hCRF group, compared to the dexamethasone control. No major safety concerns were identified in the hCRF groups. Since the number of subjects enrolled was small (a total of 33 patients), no rigorous statistical analysis could be performed. A more definitive trial of hCRF for this indication would require at least 50 patients per treatment group to evaluate 1mg hCRF compared to dexamethasone standard therapy. These findings support those of previous trials of smaller magnitude. In those trials, six out of seven patients and 10 out of 15 patients suffering from peritumoral brain edema showed improvement in neurological function under hCRF therapy. In the United States, approximately 30,000 patients are diagnosed every year with brain tumors. Patients with this condition are in need of a safe alternative to corticosteroids, which have serious adverse effects at the high, chronic doses required for efficacy. The FDA has approved NTI's application for orphan drug designation for Xerecept to treat this unmet medical need. Orphan drug designation provides NTI with seven years market exclusivity and makes the company eligible to receive federal monies for clinical research under the Orphan Drug Grant program. During fiscal 1999, NTI was awarded a Small Business Innovative Research grant of approximately $100,000 from the NIH for clinical development of Xerecept for peritumoral brain edema. In addition, NTI is currently developing its second product, Memantine, for multiple neurological conditions. The company recently announced statistically significant results from a Phase IIB trial in diabetic neuropathy. Memantine is also being investigated in a Phase II trial to treat AIDS-related dementia by the AIDS Clinical Trial Group of the National Institutes of Health. NTI is an emerging drug development company focused on the clinical evaluation and regulatory approval of neuroprotective drugs. The company's strategy is to in-license and develop early-stage drug candidates that target major medical needs and which can be rapidly commercialized. Related Link: Neurobiological Technologies, Inc.
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