Celtic, Neurobiological Technologies begin second pivotal phase 3 trial for Xerecept brain edema

By Lisa Kerner

Erie, Pa., Feb. 6 - Celtic Pharmaceutical Holdings LP and Neurobiological Technologies, Inc. announced the enrollment of the first patient into the second of two phase 3 pivotal trials of Xerecept, corticotropin-releasing factor, for peritumoral brain edema.

This second study will compare the treatment of dexamethasone with Xerecept in patients already on low-dose steroid whose dose must be escalated to treat their symptoms, according to a company news release.

Celtic said patients completing the study will have the option of entering a third, open-label study allowing them to continue receiving Xerecept.

"Xerecept continues to hold great promise for those patients affected with the neurological symptoms related with swelling around brain cancers," Neurobiological Technologies president and chief executive officer Paul E. Frieman said in the release. "We feel that the existing treatment utilizing steroids provides an extra burden to this critically ill patient population. We believe that Xerecept represents an alternative and hope to these patients for a better quality of life."

Neurobiological Technologies sold the worldwide exclusive rights to Xerecept to Celtic in November.

The companies plan to extend clinical development into Europe and Japan this year, officials said.

Neurobiological Technologies, based in Emeryville, Calif., is a drug development company focused on neuroscience drugs.

Bermuda-based Celtic is a global private equity firm focused on the biotechnology and pharmaceutical industries.

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