Neurobiological Technologies' Partner, Celtic Pharma, Announces Results of XERECEPT(R) Phase 3 Clinic...(long-term tolerability of XERECEPT(R). ...),Health

Date:6/1/2009

long-term tolerability of XERECEPT(R). Of the 113 patients enrolled, a total of 32 patients have completed one year or more of treatment in the study. Dexamethasone dosing of all patients on study was reduced progressively over time. Patients from the placebo cohort in the blinded studies entered this study with approximately double the mean dexamethasone dosing of patients from the prior active treatment cohort. The patient dosing of dexamethasone was reduced sharply once on XERECEPT(R), such that the difference between the two was no longer significant at 4 weeks. More than 50 percent of patients completing six months on study were able to achieve a virtual or complete elimination of corticosteroid treatment, and to sustain this for extended periods of time. The NTI-0501 study also showed that XERECEPT(R) therapy was well tolerated over extended periods up to two years or more.

"We are delighted to see the results from the three Phase III studies, the analysis of the brain scans from these studies, and the intriguing preclinical data regarding XERECEPT(R)," said Stephen Evans-Freke, co-Managing General Partner of Celtic Pharma. "We are especially interested in the data from the blinded and open-label studies indicating that XERECEPT(R) may offer significant clinical benefit for metastatic patients, given the very poor options available now for this substantial patient population. We look forward to reviewing these results with FDA and their European and Japanese counterparts before determining the forward path for this promising drug."

NTI-0302

NTI-0302, a Phase III randomized, double-blind study comparing XERECEPT(R) to dexamethasone for the control of acute symptoms associated with peritumoral edema, was discontinued due to slow enrollment. The study results from the 37 patients who enrolled show that XERECEPT(R) was as effective as 4mg/day of dexamethasone in the treatment of patients presenting with an a
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SOURCE Neurobiological Technologies, Inc. Copyright©2009 PR Newswire. All rights reserved

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