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

s two through five of treatment), the study demonstrated a strong trend in favor of XERECEPT(R), though it did not reach statistical significance (p=0.1). Placebo patients tolerated a 50 percent reduction in dexamethasone dosing much better than anticipated over this time frame.

However, at weeks two, five, and eight, the XERECEPT(R) treatment group demonstrated an improved overall response rate based on the primary endpoint that was statistically significant at each time point. XERECEPT(R) demonstrated a highly statistically significant (p=0.001) improvement compared to placebo over the twelve weeks of study duration in reducing dexamethasone dose levels. Fifteen percent of patients on XERECEPT(R) were able to reach 0 mg of dexamethasone (p= 0.04) within the twelve week period.

Approximately 20 percent of the patients enrolled in NTI-0303 had metastatic brain tumors (secondary to primary tumors in the breast, lung or elsewhere). In this patient population, the primary and all secondary endpoints achieved a statistically significant advantage for XERECEPT(R) treated patients, exceeding the results observed in the overall patient cohort. This is an important finding given the 360,000 patients diagnosed annually with metastatic brain tumors in North America and Europe; moreover, patient prognosis is very poor and the treatment options are very limited.

In addition, the NTI-0303 trial showed that use of XERECEPT(R) leads to statistically significant reductions in steroid-related adverse events of myopathy (muscle weakness) and Cushingoid syndrome. Specifically, patients demonstrated a statistically significant increase in Ileopsoas muscle strength. These findings show a medically important clinical benefit for patients on XERECEPT(R).

NTI-0501

Results from NTI-0501, a Phase III open label extension study of patients rolling over from the 0302 and 0303 studies, demonstrated the
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SOURCE Neurobiological Technologies, Inc.
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