Xerecept is an investigational new drug that may present an alternative to dexamethasone for patients with primary and metastatic brain tumors. Xerecept has shown in Phase II and Phase III studies that it may provide a safe and effective alternative to corticosteroid treatment for tumor-related brain edema and that it may also have direct anti-tumor activity.
Celtic Pharma’s objective for this trial is to demonstrate the tolerability to increasing doses of Xerecept in pediatric patients. Upon identification of the maximum tolerated dose, the study will continue to investigate the clinical benefits of Xerecept in this population, particularly with regard to reduction of dexamethasone dosing requirements and concomitant clinical benefit to the patients.
Stewart Goldman, medical director of the neuro-oncology unit in Feinberg School of Medicine at Northwestern University and principal investigator of the study, said: “I am excited to be working on this very important trial. The effects of dexamethasone dosing on these children who have brain tumors is heart wrenching and I look forward to working with Celtic Pharma in the testing of Xerecept in these patients.”
Stephen Evans-Freke, co-managing general partner of Celtic Pharma, said: “We have been in close contact with pediatric neuro-oncologists and look forward to the completion of this trial. This study is an important element of our forward development strategy for Xerecept, which we expect to be in registrational trials in the second half of 2010.”