Cell Therapeutics, Inc. ("the Company") (Nasdaq and MTA: CTIC) today announced new pixantrone end of study ("EOS") follow up results from the Company's pivotal phase III PIX301 trial, which results form the basis for the Company's recent Marketing Authorization Application (the "MAA") currently under review by the European Medicines Agency ("EMA").
The end-of-study results showed continued improvement in the trial's primary and secondary endpoints with increased statistical confidence around the endpoint results. At EOS, CR/CRu (Complete Response ("CR")/Complete Response unconfirmed) rate increased to 24% in the pixantrone arm compared to 7% among comparator recipients>Ruth Pettengell, M.D. of St. George's Hospital, University of London, the lead investigator for the phase III PIX301 EXTEND trial.
"The end of study results strengthen the confidence and stability across the primary and secondary measures of efficacy," noted Dr. Pettengell. "The magnitude of complete and durable responses and PFS demonstrated by pixantrone are currently not achievable using standard of care and we would welcome the opportunity to utilize this new drug for the benefit of our patients."
The poster from the conference is available at www.celltherapeutics.com/investor_updates.
To demonstrate that the dose and schedule utilized in the PIX301 trial and proposed for the follow on PIX306 study, is an appropriate dose and exposure for maximizing efficacy while minimizing side effects, the Company had an expert pharmacokinetic exposure safety and efficacy analysis conducted on data from all of its phase I, II and III trials including relapsed refractory patients with solid tumor malignancies. At an investor meeting at ASH those data were presented demonstrating that the dose of pixantrone used in PIX301 and proposed for PIX306 is an appropriate dose demonstrating a significant correlation between exposure to pixantrone and enhanced anti-tumor response (Progression-Free Survival ("PFS")) while minimizing the risk for side effects (neutropenia). The PIX306 trial is currently planned to be a randomized, single-blind study comparing pixantrone + rituximab to combination gemcitabine + rituximab in patients with relapsed or refractory aggressive B-cell non-Hodgkin's lymphoma ("NHL") who are not candidates for myeloablative chemotherapy and stem cell transplant.
A summary status update on the PIX203 front line trial of CPOP-rituximab versus CHOP-rituximab in high risk and elderly DLBCL was also presented at an investigator meeting at ASH. Given that median PFS has not yet been reached for the CPOP-R arm and the median OS has not yet been reached for both treatment arms the Company only provided a brief update on patient demographics, while summarizing key efficacy and safety endpoints of the study. The Company anticipates submitting the PIX203 data for presentation at scientific meetings once the survival and PFS data are mature.
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