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news.Cell Therapeutics, a biopharmaceutical company, has reported preliminary progression-free survival results from its pivotal Phase III Extend trial of pixantrone that show patients with advanced, relapsed aggressive non-Hodgkin's lymphoma treated with pixantrone experienced a statistically significant improvement in median progression-free survival, compared with other single-agent chemotherapeutic based on an intent to treat analysis.
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Progression-free survival (PFS) was a prospectively defined secondary endpoint in the study. 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.
The trial enrolled 140 patients and patients were randomized to receive either pixantrone or another single-agent drug currently used for the treatment of this patient population and selected by the physician. The trial was designed to examine the complete remission or unconfirmed complete remission rate, overall survival and progression-free survival.
The company expects to begin submission of a rolling NDA and request priority review for pixantrone to treat relapsed aggressive non-Hodgkin’s lymphoma in the first quarter of 2009.
James Bianco, CEO of Cell Therapeutics, said: Pixantrone is the first agent in this patient population to demonstrate a significant and meaningful PFS advantage. We believe these data will support a priority review designation on our NDA once we share them with the FDA.