Cell Therapeutics, Inc (CTI) released updated 18-month follow-up clinical data for its phase-III Extend (PIX 301) trial of pixantrone (BBR2778) for patients with advanced, relapsed or refractory, aggressive non-Hodgkin's lymphoma (NHL). Responses were evaluated by an Independent Assessment Panel that was blinded to patient assignment.

The table below shows the primary end of treatment data analyses previously reported and the new updated 18 month efficacy data analyses. This data is part of CTI's presentation today at the BioCentury NewsMakers conference at 10:30 AM ET.

"We continue to be impressed by the durability of responses in the pixantrone treatment arm which seemed to improve during the study follow up period, compared to the standard chemotherapy recipients - whose responses and duration of response are largely unchanged from the initial assessment period," noted James A Bianco, chief executive officer of CTI. "We are also encouraged by the increase in the overall survival estimates, especially among those patients whose histologic diagnosis was verified by independent pathologists where 40 per cent of pixantrone recipients were alive, compared to 27 per cent for standard chemotherapy at the 1 year landmark period. We plan to submit these updated safety and efficacy data to our NDA as part of the 120 Day update."

The FDA typically receives updated clinical study data 120 days following the initial NDA submission.

The most common (incidence greater than or equal to 20 per cent) adverse reactions reported for pixantrone-treated subjects were neutropenia, infection, anaemia, leucopenia, thrombocytopenia, asthenia, pyrexia, and cough.

Pixantrone has been accepted for standard review by the Food & Drug Administration (FDA), with fast track status with a Prescription Drug User Fee Act (PDUFA) date of April 23, 2010.

The Extend clinical trial is a phase-III single agent trial of pixantrone for patients with relapsed or refractory, aggressive nonHodgkin's lymphoma who received two or more prior therapies and who were sensitive to treatment with anthracyclines.

Pixantrone (BBR 2778), is a novel topoisomerase II inhibitor with an aza-anthracenedione molecular structure that differentiates it from the anthracyclines and other related chemotherapy agents.

Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable.