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Celtic Pharma Announces Completion of Enrollment in Dose Tolerance Trial Evaluating XERECEPT(R) in Pediatric Patients with Primary and Metastatic Brain Tumors


10/3/2011 11:46:36 AM

NEW YORK, LONDON and HAMILTON, Bermuda, Oct. 3, 2011 /PRNewswire/ -- Celtic Pharmaceutical Holdings L.P. ("Celtic Pharma") is pleased to announce the completion of enrollment into a maximum dose tolerance study of investigational product Xerecept® (corticorelin acetate) in pediatric patients who were dependent on chronic Decadron (dexamethasone) dosing due to peritumoral brain edema associated with cerebral tumors. In the open label study, 100% of the subjects showed substantive reductions in daily dexamethasone dosing requirements, with approximately 25% of patients able to completely stop steroid dosing.

The study of 15 patients was conducted by Stewart Goldman M.D. at Children's Memorial Hospital in Chicago, IL and Mark Kieran M.D. at Dana-Farber Cancer Institute in Boston, MA. Both investigators commented that the Xerecept® dosing enabled pediatric patients to reduce their dexamethasone requirements even though each patient had at least two previous attempts to reduce the doses of dexamethasone prior to entry into this study. "Both the children and their families noted to me that participation in this trial and the ability to decrease Decadron dosing improved the quality of life for the patients," added Stewart Goldman, M.D.

The daily maximum tolerated dose of Xerecept® in this study was 60g (microgram) per kilogram given in divided doses subcutaneously morning and evening.

"Chronic corticosteroid dosing is not good for anyone," commented Stephen Evans-Freke, Managing General Partner of Celtic Pharma Management L.P., "but the very high doses of dexamethasone needed to control cerebral edema in pediatric brain tumor patients have severely deleterious clinical and quality of life effects on the children. This exciting new pediatric data on Xerecept obliges us to consider a separate pathway to regulatory approval for Xerecept in pediatric patients."

About Xerecept

Xerecept is a synthetic version of the natural peptide hormone 'corticotrophin releasing factor'. Xerecept is in mid-Phase III development for the treatment of cerebral edema associated with primary and metastatic brain tumors in adults, and has been demonstrated in prior trials to be an effective alternative to the use of chronic, high-dose corticosteroids in this large patient population, while offering a benign side-effect profile even over several years of chronic administration. Recent preclinical studies from leading cancer centers have indicated that Xerecept may also have direct anti-tumor effects, and may be synergistic with Avastin in certain solid tumor indications. Xerecept is expected to have significant patent protection through 2033.

About Celtic Pharmaceutical Holdings L.P.

Celtic Pharmaceutical Holdings L.P. (Celtic Pharma) is a global private equity investment 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, with offices in New York and London. Celtic Pharma has acquired and invested in late stage pharmaceutical programs and manages these programs through their development for ultimate sale to established pharmaceutical companies. Celtic Pharma is fully invested at this time. Celtic Pharma's aim has been 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 www.celticpharma.com.

SOURCE Celtic Pharmaceutical Holdings L.P.



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