Cell Therapeutics, Inc. (the "Company") (Nasdaq and MTA: CTIC) today reported exploratory analyses of the data at study completion from the Company's pivotal PIX301 trial of Pixuvri(TM) (pixantrone dimaleate), the first randomized controlled trial in patients with relapsed or refractory, aggressive non-Hodgkin's lymphoma ("NHL"). These analyses demonstrated that patients who achieved a complete response (CR)/unconfirmed complete response (CRu) to Pixuvri had up to a 63% probability of being alive at 24 months compared to a 20% probability for patients treated with comparator agents. The study showed a 21% improvement in overall survival for all patients who received Pixuvri that was independent of factors known to influence survival like prior rituximab use, international prognostic index (IPI) score, prior stem cell transplant, baseline level of LDH (lactate dehydrogenase), or refractory status based on univariate Cox regression analyses of survival. These data were presented at a Company-sponsored lymphoma expert panel during the 15th Congress of the European Hematology Association.
"The overall strength of evidence, including the significant increases observed in clinically-important parameters like overall response rates (ORR) and progression free survival (PFS), provides important support to the clinical benefit of Pixuvri compared to current single-agent treatment in a setting where there are no approved or consensus therapies for relapsed or refractory aggressive NHL," said Dr. Andreas Engert, University Hospital of Cologne. "The updated end-of-study survival data demonstrates a lasting benefit of achieving a CR/CRu with Pixuvri, with 8 of the 12 patients known alive at end of study having achieved a CR/CRu. It is particularly notable that overall survival was not influenced by important risk factors, and also that 76% of the patients who achieved a CR/CRu with Pixuvri failed to respond to or had a lesser response to their last multi-agent therapy. I look forward to working with the Company as it prepares for submission of its Marketing Authorization Application ("MAA") for Pixuvri to the European Medicines Agency ("EMEA")."
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