We are pleased to hear that the US Food and Drug Administration (FDA) accepted and filed for review Cell Therapeutics’ (CTIC) New Drug Application (NDA). The company is seeking FDA approval (NDA filed in June 2009) for pixantrone for the treatment of relapsed and refractory non-Hodgkin’s lymphoma (NHL). Though an action date is yet to be published, the company expects the FDA to take a final decision regarding the review status by Sept 4.

Earlier in June, Cell Therapeutics presented encouraging results from a phase III trial of pixantrone. Although the efficacy data for pixantrone were encouraging, we are concerned about its side effects. While, neutropenia was 41.2% for pixantrone versus 19.4% for comparator, leukopenia was 23.5% for pixantrone versus 4.5% for comparator.

Although the grade 3, 4 cardiac disorder was similar among the two treatment groups (1.5% vs. 1.5%), there was a higher incidence of serious cardiac disorders in patients

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Positive interim data from phase 2 clinical trials of lead drug candidate MT103Micromet, Inc. (MITI) announced yesterday that the German Multicenter ALL Study Group presented phase 2 clinical data of lead drug candidate BiTE antibody blinatumomab (MT103) at the 14th Congress of the European Hematology Association held recently in Berlin, Germany, showing a high response rate in acute lymphoblastic leukemia (ALL) patients with minimal residual disease (MRD).The patients included in this phase 2 clinical trial were in complete hematological remission following intense chemotherapy regimens, but had retained a detectable level of ALL cancer cells in their bone marrow, so called minimal residual disease (MRD). Various studies have confirmed that ALL patients with MRD following chemotherapy have a significantly worse prognosis than patients without MRD.The ALL interim data showed an MRD response rate above 80%, which significantly exceeded the rate which was considered ...

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 ...