Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) today 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.
"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, M.D., 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% of pixantrone recipients were alive, compared to 27% 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%) adverse reactions reported for pixantrone-treated subjects were neutropenia, infection, anemia, 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.