Pixantrone Produces High Rates Of Complete Remission In Multiple Relapsed And Refractory Indolent And Aggressive Non-Hodgkin's Lymphoma

Main Category: Lymphoma / Leukemia / Myeloma
Also Included In: Clinical Trials / Drug Trials;  Pharma Industry / Biotech Industry
Article Date: 23 Oct 2009 - 2:00 PDT

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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.

About Pixantrone

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. Anthracyclines are the cornerstone therapeutic for the treatment of lymphoma, leukemia, and breast cancer. Although they are sufficiently effective to be used as first-line (initial) treatment, they cause cumulative heart damage that may result in congestive heart failure many years later. As a result, there is a lifetime limit of anthracycline doses and most patients who previously have been treated with an anthracycline are not able to receive further anthracycline treatment if their disease returns. It also can be administered through a peripheral vein rather than a central implanted catheter as required for other drugs in this class. Pixantrone has been granted fast track status designation.

About Cell Therapeutics, Inc.

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

This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the trading price of the securities of CTI. Specifically, the risks and uncertainties that could affect the development of pixantrone include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general, and with pixantrone in particular, including, without limitation, the potential failure of pixantrone to prove safe and effective (including the failure to achieve the overall response rate and complete remissions) for the treatment of relapsed or refractory, aggressive NHL as determined by the FDA , CTI's ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, costs of developing, producing and selling pixantrone, and the risk factors listed or described from time to time in CTI's filings with the Securities and Exchange Commission including, without limitation, CTI's most recent filings on Forms 10-K, 10-Q and 8-K. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.

Source: Cell Therapeutics, Inc