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Celtic Pharma Provides Update on XERECEPT(R) Clinical Program
Date:12/5/2007

hasone dose. The trial is currently enrolling eligible patients with primary or secondary (metastatic) brain tumors who have already completed one of two Phase III randomized, double-blind trials of XERECEPT(R) currently underway at 27 centers in the U.S., Canada, Australia and New Zealand.

""Side effects of high-dose corticosteroid treatment have a devastating effect on quality-of-life and potentially on life expectancy, and any option that significantly reduces the use of dexamethasone would be a major benefit to patients," said Dr. Patrick O'Connor, Head of Clinical Development at Celtic Pharma. "The interim data presented at SNO are promising and we remain optimistic about the prospects for XERECEPT(R)."

"Celtic Pharma also announced plans to initiate an imaging study, CPDS 0701, to assess more directly the effects of XERECEPT(R) on PBE. Sequential brain scans from some glioblastoma patients being treated with XERECEPT(R) suggest reduction of edema. The imaging study will aim to establish whether this observation can be substantiated over a larger patient population. The multicenter, open-label, randomized study will investigate the efficacy and safety of XERECEPT(R) for the reduction of PBE in patients with primary or metastatic brain tumors. The study is targeted to begin enrolling patients in early 2008 at investigational sites in the United States and Canada.

"Separately, Celtic Pharma announced the discontinuation of enrollment in study NTI 0302, a Phase III randomized, double-blind study comparing XERECEPT(R) to dexamethasone in first line treatment of symptoms associated with PBE in patients newly diagnosed with primary malignant glioma. The decision to discontinue enrollment for this trial was due to slower than anticipated recruitment and Celtic Pharma's conclusion that the new CPDS 0701 imaging study would be a more important contributor to the overall robustness of the XERECEPT(R) development program. No safety issues prompted thi
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SOURCE Neurobiological Technologies, Inc.
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