Opaxio awaits EMEA approval by the end of 2009 There is some good news for Cell Therapeutics (CTIC) as the European Medicines Agency (EMEA) today agreed to an oral explanation in support of the Opaxio Marketing Authorization Application (MAA) in September, 2009. The agency has extended the timeframe for review by the Committee for Medicinal Products for Human Use (CHMP) regarding the approval until the fourth quarter of 2009. Earlier, in April, 2008 the EMEA accepted for review the MAA of Opaxio for the treatment of patients with advanced non-small cell lung cancer (NSCLC). The meeting with the EMEA was scheduled to take place on June 2009, but did not occur as the company was busy submitting the pixantrone (for the treatment of NHL) New Drug Application (NDA). Although Opaxio was undergoing clinical trials since 2005, all of them failed to meet the primary end-point ...

Surge of CTIC on PIX301 Trial Data: Sustainable?Pixantrone is more efficacious than comparators but with safety concernsYesterday afternoon (June 1), Cell Therapeutics, Inc. (CTIC) presented updated final results of its pivotal phase III EXTEND (PIX301) trial of Pixantrone in relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL) at the 2009 American Society for Clinical Oncology (ASCO) Annual Meeting held in Orlando, Florida.The PIX 301 EXTEND trial was a phase III single-agent trial of Pixantrone for patients with relapsed or refractory aggressive NHL who received two or more prior therapies and who were sensitive to treatment with anthracyclines. The trial enrolled 140 patients and patients were randomized to receive either Pixantrone (N=70) or another single-agent drug (N=70) currently used for the treatment of this patient population and selected by the physician.Efficacy data encouragingThe efficacy data were encouraging. Patients treated with ...