Cell Therapeutics, Inc (CTI) announced that it has closed the data set for preliminary analysis of the primary endpoint in the phase-III EXTEND (PIX301) trial of pixantrone (BBR2278) for patients with relapsed diffuse large B cell non-Hodgkin's lymphoma (NHL) and it has provided Novartis notice that the data set has been closed. The primary endpoint for the study is the complete remission (CR) and unconfirmed complete remission (uCR) rate in patients receiving either pixantrone or another single agent chemotherapeutic drug. CTI plans to report top-line results in November.
"We are excited to have reached the end of the treatment phase and follow-up period for the pixantrone pivotal study and look forward to reporting top-line results in November," said James A. Bianco, CEO of Cell Therapeutics. "Complete remissions in this patient population with end stage advanced disease are seldom accomplished with the current standard of care. Pixantrone, if successful in achieving the study objectives, could offer these patients a significant benefit, and we would work with the FDA to submit an NDA in 2009."
CTI has an existing license and co-development agreement with Novartis for Opaxio (paclitaxel poliglumex, CT-2103), which also provides Novartis with an option to enter into an exclusive worldwide license to develop and commercialize pixantrone based upon agreed terms.
The EXTEND clinical trial is a phase-III single agent trial of pixantrone for patients with relapsed, aggressive non-Hodgkin's lymphoma who received two or more prior therapies and who were sensitive to treatment with anthracyclines.
Pixantrone (BBR 2778), a DNA intercalating antitumor agent that contains an aza-anthracenedione molecular structure, differentiating it from anthracycline chemotherapy agents, was discovered by our scientists in Bresso, Italy.
Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable.