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CTI Announces Enrollment Completion of NCI-Sponsored Cooperative Group Phase III Trial of TRISENOX Consolidation in Treatment of Newly Diagnosed Patients With Acute Promyelocytic Leukemia

- Study Results May Provide Basis for Supplemental NDA (sNDA)

SEATTLE, April 5 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; Nuovo Mercato) announced today that a phase III study of TRISENOX consolidation treatment in patients with newly diagnosed acute promyelocytic leukemia (APL) completed enrollment with approximately 500 patients. The study is being conducted under the Cooperative Research and Development Agreement (CRADA) between CTI and the U.S. National Cancer Institute (NCI) and involves three of the largest adult cooperative groups; the Eastern Cooperative Oncology Group (ECOG), the Southwest Oncology Group (SWOG), and the Cancer and Leukemia Group B (CALGB), along with the National Cancer Institute of Canada (NCIC) and the Children's Oncology Group (COG).

If TRISENOX improves event-free survival, CTI may explore the potential to use the results to file a sNDA for TRISENOX in first-line, consolidation for APL patients. CTI markets TRISENOX (arsenic trioxide) in the United States and Europe for the treatment of patients with APL who have relapsed from or who are refractory to standard chemotherapy.

"ATRA plus an anthracycline followed by maintenance ATRA and combination chemotherapy remains the cornerstone for curative treatment of most patients with newly diagnosed, untreated APL, however, between 20 and 30 percent of patients still relapse," stated Jack W. Singer, Chief Medical Officer of CTI. "As a single agent in relapsed/refractory APL, TRISENOX produces a high rate of complete remissions (CRs), mostly molecular CRs and it may be curative as single-agent therapy for some of these patients who have remained relapse-free for several years.

This study seeks to determine whether the addition of two, 25 day cycles of TRISENOX consolidation following standard induction therapy can increase the event-free survival for adult patients with APL. If positive, results from this study may provide a basis for inclusion of TRISENOX in first-line therapy of APL, particularly in patients known to be at higher risk for relapse."

About the study

The study, which was initiated in June 1999, seeks to determine if TRISENOX consolidation therapy prolongs the event-free survival of untreated, newly diagnosed APL patients when added to the standard induction regimen of ATRA and chemotherapy compared to standard ATRA and chemotherapy alone. A secondary endpoint of the study is to examine the effectiveness of adding chemotherapy to maintenance ATRA therapy compared to maintenance ATRA alone.

About TRISENOX®

TRISENOX® (arsenic trioxide) is marketed by CTI. TRISENOX was approved for marketing in 2000 by the U.S. Food and Drug Administration to treat patients with relapsed or refractory acute promyelocytic leukemia (APL), a rare, life-threatening form of cancer of the blood. TRISENOX was granted marketing authorization from the European Commission in March 2002. APL, one of eight subtypes of acute myeloid leukemia (AML), represents 10-15 percent of the more than 20,000 patients diagnosed with AML each year. TRISENOX is currently being studied in more than 40 clinical and investigator-sponsored trials in a variety of cancers.

U.S. marketing approval for TRISENOX was granted based on results from a U.S. multicenter study in which 40 relapsed APL patients were treated with TRISENOX 0.15 mg/kg until bone marrow remission or a maximum of 60 days. Thirty-four patients (85 percent) achieved complete remission. When the results for these 40 patients were combined with those for the 12 patients in a pilot trial, an overall response rate of 87 percent was observed.

WARNING: TRISENOX should be administered under the supervision of a physician who is experienced in the management of patients with acute leukemia. Some patients with APL treated with TRISENOX have experienced APL differentiation syndrome -- with symptoms similar to retinoic acid-acute promyelocytic leukemia (RA-APL) syndrome. Arsenic trioxide can cause QT prolongation (which can lead to torsade de pointes) and complete atrioventricular block.

The most common adverse events associated with TRISENOX have been generally manageable, reversible and usually did not require interruption of therapy. These have included hypokalemia, hypermagnesemia, hyperglycemia and thrombocytopenia as reported in 13 percent of the patients (n=40). Abdominal pain, dyspnea, hypoxia, bone pain and neutropenia were reported in 10 percent of these patients, while arthralgia, febrile neutropenia and disseminated intravascular coagulation were reported in eight percent of patients.

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. For additional information, please visit www.cticseattle.com.

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. Specifically, the risks and uncertainties that could affect the development of TRISENOX in APL include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with CTI's products under development in particular including, without limitation, the potential failure of TRISENOX to prove safe and effective for treatment of APL, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling TRISENOX, and the risk factors listed or described from time to time in the Company's filings with the Securities and Exchange Commission including, without limitation, the Company's most recent filings on Forms 10-K, 8-K, S-3 and 10-Q. CTI is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.

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Source: Cell Therapeutics, Inc.

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