Cell Therapeutics, Inc (CTI) has submitted an expanded Paediatric 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 EU for the treatment of relapsed or refractory, aggressive non-Hodgkin's lymphoma (NHL). CTI intends to file the MAA later this year. The paediatric programme will study pixantrone in paediatric patients aged six months to 18 years with the goal of determining the comparative safety and effectiveness of pixantrone compared to doxorubicin in paediatric lymphoid cancers.
CTI submitted the original PIP in September 2009. In April 2010, the EMEA Paediatric 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 haematologic cancer.
"Our discussions with the paediatric 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 tumours. 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."
Pixantrone is a novel aza-anthracenedione that has distinct structural and physio-chemical properties that make its anti-tumour activity unique in this class of agents.
CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable.