Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced that Dr. Richard Van der Jagt of the Ottawa General Hospital will present at the Lymphoma and Myeloma 2009 Conference in New York an overview of CTI's pixantrone phase II and phase III clinical studies that demonstrated high rates of complete remission (CR) in relapsed/refractory aggressive and indolent non-Hodgkin's lymphoma (NHL) patients.
Highlights from the presentation include studies in which pixantrone was used in combination with other agents:
- 70% CR/CRu rate in a phase II trial in patients treated with pixantrone plus FPD-R regimen (fludarabine and rituximab) in relapsed/refractory indolent NHL
- 47% CR/CRu rate in a phase II trial in patients treated with CPOP regimen (cyclophosphamide, pixantrone, vincristine, prednisone) for patients that failed CHOP (cycophosphamide, doxorubicin, vincristine, prednisone) regimen with relapsed/refractory aggressive NHL
- 35% CR rate in a phase III trial in patients treated with pixantrone plus rituximab in relapsed/refractory indolent NHL
The most common (incidence greater than or equal to 10%) grade 3-4 adverse events reported for pixantrone-treated subjects across the studies were neutropenia and leucopenia. Other common adverse events (any grade) included infection, anemia, leucopenia, thrombocytopenia, asthenia, pyrexia, and cough.
"Complete remission is the gold standard in relapsed/refractory NHL beyond second relapse. Complete remissions are relatively infrequently achieved with current combination regimens in this patient group. The results from the pixantrone clinical trials are impressive and indicate the potential for this drug to meet a significant unmet medical need in patients with relapsed or refractory NHL," said Dr. Gary Schiller of the UCLA School of Medicine. "These patients have few options and the availability of an effective treatment would be well received."
Pixantrone is a fast track designated product which has been accepted for review by the U.S. Food & Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) date of April 23, 2010.