Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that it has submitted an expanded Pediatric Investigation Plan ("PIP") to the European Medicines Agency ("EMEA"), as part of the process for its submission for a Marketing Authorization Application ("MAA") for pixantrone in the E.U. for the treatment of relapsed or refractory, aggressive non-Hodgkin's lymphoma (NHL). CTI intends to file the MAA 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.
CTI submitted the original PIP in September 2009. In April 2010, the EMEA Pediatric Committee (the "PDCO") recommended CTI expand the PIP because of 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.
"Our discussions with the pediatric experts on the PDCO indicated that they agree with our belief that the need for a less toxic, more effective anthracycline-like agent is significant, not only in lymphoma, but potentially in other tumors. We were pleased to accommodate their suggestions and have adjusted the PIP accordingly," said Jack Singer, Chief Medical Officer of CTI. "Filing the updated PIP puts us one step closer to completing the MAA submission process, and moves us towards our goal of making pixantrone available to suitable patients."
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