23-05-2012: Celtic Pharmaceutical Holdings L.P. announced that it has completed a successful Phase I/II study of the investigational new drug Xerecept® (corticorelin acetate) in pediatric patients who are dependent on the steroid Decadron (dexamethasone) to treat peritumoral brain edema associated with cerebral tumors. Initial indications are that Xerecept® can reduce or eliminate the need for Decadron use and provide significant quality of life improvements.
The study, involving 15 children, 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. All of the children enrolled on the study had severe steroid-induced side effects and had been unable to decrease dexamethasone dosing in spite of two attempts by the attending physicians to reduce the daily steroid dose levels.
Consistent with responses seen in the adult clinical trials of Xerecept®, nearly all of the pediatric patients were able to substantially reduce their dose of dexamethasone from baseline. Many of these patients were able to eliminate steroid use altogether for significant periods. The daily maximum tolerated dose of Xerecept® in this study was 60μg per kilogram given in divided doses subcutaneously morning and evening.
The benefit of Xerecept® was also seen with clinically important improvements in patient functioning being recorded utilizing the PedsQL, a quality of life instrument which has been validated for use in pediatric patients with cerebral tumors. No significant drug-related side effects were observed in any of these patients.
Subsequent to completion of the study, Celtic Pharma has held an end of Phase II meeting with the FDA’s Oncology Division, to discuss the pathway for registration of Xerecept® in this pediatric indication and the appropriate primary end-point for a follow on pivotal study. The FDA has provided good guidance on these points, and it was agreed that Celtic Pharma would submit a detailed protocol for a pivotal study in pediatric patients for review by the Agency in the near future.
Celtic Pharmaceutical Holdings L.P. announced that it has completed a successful Phase I/II study of the investigational new drug Xerecept® (corticorelin acetate) in pediatric patients who are dependent on the steroid Decadron (dexamethasone) to treat peritumoral brain edema associated with ... more
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