Cell Therapeutics, Inc. announced today that it has received notice that the European Medicines Agency (“EMEA”) has validated the expanded Pediatric Investigation Plan (“PIP”) that CTI filed in July for pixantrone for the treatment of relapsed or refractory, aggressive non-Hodgkin’s lymphoma (NHL). Following the validation, the EMEA Pediatric Committee (the “PDCO”) will review and comment or approve the content of pediatric plan. Once the PIP is approved, CTI will submit the Marketing Authorization Application (“MAA”) for pixantrone in the E.U. later this year. The pediatric program will study pixantrone in pediatric patients aged 6 months to 18 years with the goal of determining the comparative safety and effectiveness of pixantrone compared to doxorubicin in pediatric lymphoid cancers.
“We are very pleased that the EMEA has validated the expanded PIP for pixantrone, as there is a real need for a less toxic, more effective anthracycline-like treatment option not only in lymphoma, but also possibly in other tumors,” said Jack Singer, Chief Medical Officer of CTI. “We look forward to completing the MAA submission, and continuing to pursue our goal of providing pixantrone as a treatment option to the patients who need it most.” CTI submitted the updated, expanded PIP in July 2010 after the PDCO recommended CTI expand the original PIP of September 2009 to include pixantrone’s potential, but unproven, clinical benefit to children in reducing long-term cardiotoxicity associated with current curative therapies. The recommendation from the PDCO came following discussions with CTI about the preclinical and clinical pixantrone data, including PIX301, and the desire to explore the potential benefits pixantrone may offer to children with hematologic cancer.