NeoPharm Inc announced further progress in its clinical development program for IL13-PE38, NeoPharm's novel tumor-targeted agent. Enrollment has begun in the first global Phase I/II clinical trial of IL13- PE38; the third clinical study to date in patients with recurrent or progressive malignant glioma.
The trial is being conducted at six participating sites including University Hospital Eppendorf and University Hospital Kiel in Germany, Chaim Sheba Medical Center and Dana Hospital Tel Aviv in Israel, Cleveland Clinic and University of Colorado in the United States. The trial's first cohort of three patients was enrolled in the first month of operation.
James M. Hussey, NeoPharm's President and CEO commented: "The vast unmet global need for an effective treatment for malignant glioma has influenced our clinical development strategy. Premier research sites outside the United States have joined our cadre of U.S. centers to help expedite the world-wide development of IL13-PE38."
NeoPharm has exclusively licensed IL13-PE38 from the National Cancer Institute and the FDA, and is developing the agent under a Cooperative Research and Development Agreement (CRADA) with the FDA's Center for Biologics Evaluation and Research (CBER). The compound received orphan drug designation from the FDA in November 2001 and EC in May 2002. Additionally, the IL13-PE38 development program has received fast track designation by the FDA.