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Title: Celtic Pharma and Neurobiological Technologies Present an Update on Corticorelin Acetate Injection for Peritumoral Brain Edema
URL: http://www.pslgroup.com/dg/2054AE.htm
Doctor's Guide
November 17, 2006


Study presented at the 11th Annual Meeting of the Society For Neuro-Oncology

NEW YORK, LONDON, and HAMILTON, BERMUDA -- November 17, 2006 -- Celtic Pharmaceutical Holdings, L.P. and Neurobiological Technologies Inc. announced today that they presented a poster at the 11th Annual Meeting of the Society For Neuro-Oncology (SNO) taking place in Orlando, Florida through November 19, 2006.

The poster provided an interim report of an open-label extension study as part of an ongoing phase 3 clinical program for Xerecept(R) (corticorelin acetate injection). The open-label extension study is evaluating Xerecept's long-term safety and tolerability as a new potential treatment for peritumoral brain edema (PBE), or tumor-related brain swelling.

Xerecept is an investigational new drug that may present a steroid-sparing alternative to dexamethasone. Dexamethasone is currently the standard treatment for PBE, but is associated with debilitating side effects including vision problems, muscle and bone loss, impaired wound healing and opportunistic infections. Preclinical studies have also shown dexamethasone may increase brain tumor cell resistance to chemotherapy, inhibiting the efficacy of these targeted cancer therapies.

The interim report presented at SNO included 20 subjects who took corticorelin acetate for at least 4 weeks in the ongoing extension study. Of the subjects, 11 reduced their dexamethasone dosage during the study and 2 took no concomitant dexamethasone. Improvement or resolution of steroid related conditions was observed in 8 of 18 (45%) of subjects with such conditions at baseline. Typically refractory subjects whose dexamethasone dose was reduced included subjects who were more than 55 years of age, had recurrent brain tumors, or had failed previous attempts at dexamethasone reduction. Several of the patients showing clinical benefit from corticorelin acetate are individuals with metastatic brain tumors originating from a primary tumor elsewhere in the body. No subject required early discontinuation of treatment due to adverse events related to corticorelin acetate.

The open-label extension study is currently enrolling eligible PBE patients with primary or secondary (metastatic) brain tumors who have completed one of two Phase III randomized, double-blind trials. These trials are presently enrolling at 21 centers in the U.S. and Canada.


SOURCE: Celtic Pharmaceutical Holdings, L.P.

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