CTI Reports Pixantrone Clinical Studies

Cell Therapeutics (CTI) has reported pixantrone clinical studies, including follow-up data and subgroup analyses of high risk patients, from the phase-III Extend Pix 301 clinical trial of pixantrone (the PIX 301 EXTEND trial).

The follow up data in the Pix 301 extend trial demonstrated that three additional patients in the pixantrone arm achieved a complete remission (CR). One additional patient achieved a unconfirmed complete remission (Cru) during the follow-up period of patients that received chemotherapy on the control arm.

Including the treatment and follow-up period, pixantrone had a significantly higher complete remission rate, as compared to the patients who received standard chemotherapy. CR/CRu rate=24% for pixantrone as compared to CR/CRu rate=7% for standard chemotherapy.

The overall response rate (ORR) was also significantly higher for patients treated with pixantrone and was 40% for pixantrone, as compared to 14.3% for standard chemotherapy.

James Bianco, CEO of CTI, said: It is gratifying that we are seeing more patients convert to complete remission after the initial assessment period with pixantrone compared to other agents. These additional late responders are likely to have a positive impact on analyses of progression free and overall survival and will be provided to the FDA during the 120-day update,

We plan to request priority review of the NDA from the FDA as we believe that pixantrone would provide patients and physicians with a compelling new option in treating this disease, he added.