Cell Therapeutics Announces Agreement for Phase II Study of Pixantrone in Metastatic Breast Cancer
SEATTLE, May 13 /PRNewswire-FirstCall/ — Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) (the “Company”) today announced an agreement with the North Central Cancer Treatment Group (NCCTG) to conduct a phase II study of pixantrone in patients with HER2-negative metastatic breast cancer who have tumor progression after at least two, but not more than three, prior chemotherapy regimens. The trial will be conducted through the NCCTG, a national network of cancer specialists at community clinics, hospitals, and medical centers in the United States and Canada. The research base for NCCTG is located at Mayo Clinic in Rochester, MN.
“We are very pleased that the NCCTG has selected pixantrone for this study. Patients with HER2-negative breast cancer who have relapsed after primary chemotherapy have a need for effective and well-tolerated new agents. Although highly active, usage of drugs in the anthracycline class as salvage agents has declined, predominantly due to concerns regarding cardiac toxicity,” said Jack Singer, M.D., Chief Medical Officer of the Company. “Based on its safety and activity in non-Hodgkin’s lymphoma, pixantrone has the potential to be an active agent in breast cancer that could be safely used in this setting. We look forward to the NCCTG initiating this trial.”
The proposed trial design is to test two different dosing schedules of pixantrone. Patients on the trial will be randomized to receive either 180 mg/m2 every three weeks, or 85 mg/m2 weekly for three weeks with a one-week break. The goal of the trial would be to test the safety and efficacy of each regimen and potentially select the one with the best benefit/risk profile for further development in a phase III trial against a standard second- or third-line treatment.
Pixantrone is a novel aza-anthracenedione that has distinct structural and physio-chemical properties that make its anti-tumor activity unique in this class of agents. Similar to anthracyclines, pixantrone inhibits Topo-isomerase II but unlike anthracyclines–rather than intercalation with DNA–pixantrone alkylates DNA–forming stable DNA adducts, with particular specificity for CpG rich, hyper-methylated sites. These structural differences resulted in significantly enhanced anti-lymphoma activity compared to doxorubicin in preclinical models. In addition, the structural motifs on anthracycline-like agents that are responsible for the generation of oxygen free radicals and the formation of toxic drug-metal complexes have also been modified in pixantrone to prevent the binding of iron and perpetuation of superoxide production,–both of which are the putative mechanism for anthracycline induced acute cardiotoxicity. These novel pharmacologic differences may allow re-introduction of anthracycline like potency in the treatment of relapsed/refractory aggressive lymphoma without unacceptable rates of cardiotoxicity.
The North Central Cancer Treatment Group (NCCTG) is a national clinical research group sponsored by the National Cancer Institute. NCCTG consists of a network of cancer specialists at community clinics, hospitals and medical centers in the United States and Canada. NCCTG is dedicated to bringing clinical trials with promising new cancer therapies to communities where patients live. NCCTG specializes in researching methods of treating and preventing cancer, and in researching methods to alleviate the side effects of cancer and cancer treatments.
For additional information on NCCTG and NCI’s Clinical Trials Cooperative Group Program please visit http://www.cancer.gov/cancertopics/factsheet/NCI/clinical-trials-cooperative-group.
About Cell Therapeutics, Inc.
Headquartered in Seattle, the Company 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.CellTherapeutics.com.
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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 Company’s securities. 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, include, without limitation, the potential failure of pixantrone to prove safe and effective for the treatment of breast cancer as determined by the U.S. Food and Drug Administration and/or the European Medicinal Agency, that the Company cannot predict or guarantee the pace or geography of enrollment of its clinical trials, the Company’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 the Company’s filings with the Securities and Exchange Commission including, without limitation, the Company’s most recent filings on Forms 10-K, 10-Q and 8-K. Except as may be required by law, the Company does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.
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