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Neurobiological Technologies' Partner, Celtic Pharma, Announces Results of XERECEPT(R) Phase 3 Clinical Program
Date:6/1/2009

III studies of XERECEPT(R) (corticorelin acetate), compared to dexamethasone, the current standard of care in the treatment of cerebral edema associated with brain tumors, and an open-label rollover Phase III study of XERECEPT's long-term safety and effectiveness in these patients. Celtic Pharma believes these studies demonstrate that XERECEPT(R) was well tolerated and enabled clinically significant reductions in corticosteroid use in patients with cerebral edema associated with both primary and metastatic brain tumors. The Company also announced the results of several preclinical studies demonstrating potential anti-tumor and angiogenesis inhibition effects of XERECEPT(R).

"The ability to reduce the use of steroids and concomitant reduction in adverse side effects in the treatment of patients with brain tumors is an important goal," said Lawrence Recht, MD, Professor of Neurology and Neurological Sciences, Stanford University Medical Center. "The results of these late-stage studies are encouraging, both in terms of lowering dexamethasone use over the longer-term and the impact seen in metastatic patients, a large group with limited treatment options. The preclinical tumor model studies indicate that XERECEPT(R) also has anti-tumor activity."

NTI-0303

The results from NTI-0303, a Phase III multi-center, placebo-controlled, randomized clinical study conducted at more than 25 sites in the US and Canada, showed that XERECEPT(R) enabled substantial decreases in steroid usage and its associated side effects in both acute and long-term treatment of patients with edema associated with either primary or metastatic brain tumors. The primary endpoint of this study was a composite of three factors during weeks two through five: a 50 percent reduction in dexamethasone, stable or improved Karnofsky performance status and stable or improved 10-item Neurological Examination Scores. On the primary endpoint (during week
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SOURCE Neurobiological Technologies, Inc.
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