Cell Therapeutics, Inc. (Nasdaq and MTA: CTIC) (the "Company") today announced the European Medicines Agency (the "EMEA") Pediatric Committee (the "PDCO") recommended the Company submit an updated Pediatric Investigation Plan ("PIP") for pixantrone following discussions with the Company 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. The Company expects to submit a revised PIP to the EMEA by the end of the second quarter of 2010. The PIP outlines how the Company proposes to study the drug in children in order to benefit child health.
"We were pleased and encouraged that the pediatric experts on the PDCO believe that there is an important need for a less toxic and effective anthracycline-like agent, not only in lymphoma and also potentially in other tumors, and that it is important that pixantrone be evaluated in a pediatric population given its potential to fulfill this need," said Jack Singer, M.D., Chief Medical Officer of the Company. "The PDCO was very helpful in outlining the type of phase I and phase II studies they would like to see included in our Marketing Authorization Application (MAA) for pixantrone and that these studies could be deferred until after the potential MAA approval next year."
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