Start Of Second Pivotal Phase III Clinical Trial For XERECEPT(R), A Therapy For Peritumoral Brain Edema, Celtic Pharma And Neurobiological Technologie

Main Category: Neurology / Neuroscience
Also Included In: Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 07 Feb 2006 - 7:00 PDT

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Celtic Pharmaceutical Holdings L.P. ("Celtic Pharma") and Neurobiological Technologies, Inc. (Nasdaq: NTII) ("NTI") today announced the enrollment of the first patient into the second of two Phase III pivotal trials of XERECEPT(R), Corticotropin-Releasing Factor, for the indication of peritumoral brain edema. This second study, termed the Acute Trial, will compare the treatment of dexamethasone with XERECEPT in patients already on low dose steroid whose dose must be escalated to treat their symptoms. Once patients complete the study, they have the option of entering a third, open-label, study allowing them to continue receiving XERECEPT. In November 2005, NTI sold the worldwide exclusive rights to XERECEPT to Celtic Pharma, and provides Celtic with contractual services surrounding the development of XERECEPT.

Paul E. Freiman, President and CEO of NTI said, "XERECEPT continues to hold great promise for those patients affected with the neurological symptoms related with swelling around brain cancers. 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."

"We are delighted to see this exciting drug candidate now in three Phase III programs, and we look forward to extending its clinical development into Europe and Japan in the course of this year. This product fits the Celtic Pharma mandate in that, if we can receive regulatory approval and bring it to market succesfully, we believe it could represent a substantive improvement over current therapeutic options for the treatment of edema, thus representing a potentially large commercial opportunity", said Stephen Evans-Freke, Managing General Partner, Celtic Pharmaceutical Holdings L.P.

About Celtic Pharmaceutical Holdings L.P.

Celtic Pharmaceutical Holdings L.P. (Celtic Pharma) is a global private equity firm focused on the biotechnology and pharmaceutical industries. Celtic Pharma was founded by Stephen Evans-Freke and John Mayo, CBE and is based in Bermuda. Celtic Pharma acquires late stage pharmaceutical programmes and drives these programmes through the final stages of regulatory approval. Celtic Pharma's aim is to bridge the gap between the established pharmaceutical companies' new product pipeline crisis and the biotech industry's capital drought. For further information, please visit Celtic Pharma's website at http://www.celticpharma.com.

About Neurobiological Technologies, Inc.

NTI is a drug development company focused on the clinical evaluation and regulatory approval of neuroscience drugs. The company's strategy is to in-license and develop early- and later-stage drug candidates that target major medical needs and which can be commercialized. NTI expects to continue to acquire and develop brain drug candidates and intends to develop the resources to market these drugs in selected world regions. NTI's goal is to develop and market drug candidates in the United States, Europe and Asia and may seek partnerships with pharmaceutical and biotechnology companies to assist in development and marketing. For further information, please visit NTI's website at http://www.ntii.com.