SEATTLE, Aug. 4 Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) today announced it has filed for a Special Protocol Assessment ("SPA") with the U.S. Food and Drug Administration ("FDA") for the design of its new phase III trial of pixantrone for patients with relapsed or refractory aggressive B-Cell non-Hodgkin's lymphoma ("NHL").
In the filing, CTI proposed to the FDA that the randomized study will compare pixantrone plus rituximab against the current standard regimens used to treat this patient group. This trial is planned to enroll relapsed or refractory aggressive B-Cell NHL patients who failed first-line to third-line treatment with standard chemotherapy and are not transplant eligible.
"We anticipate the majority of the patients for this trial will be enrolled in the U.S.," said Jack Singer, M.D., Chief Medical Officer at CTI. "There are no approved agents in this setting and no standard of care regimens so the unmet medical need is notable. We have proposed that the major endpoints for the trial will include response rate, progression free survival, as well as overall survival."
Following the FDA's feedback on the trial design and the endpoints, CTI plans to initiate this study later in 2010.
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.
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.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 market price of CTI'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, including, without limitation, the potential failure of pixantrone to prove safe and effective for the treatment of relapsed or refractory aggressive NHL and/or other tumors as determined by the FDA and/or the EMEA, that the FDA may not accept CTI's SPA and/or the proposed design for the protocol of CTI's clinical trial and/or may request additional clinical trials, that the FDA may revise or may not accept the proposed endpoints for the additional clinical trial, that if CTI conducts an additional clinical trial, it may not demonstrate the safety and effectiveness of pixantrone, that CTI cannot predict or guarantee the pace or geography of enrollment of its clinical trials, including whether or not the majority of the patients will be enrolled in the U.S., that CTI may not initiate the new trial in 2010, and 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.
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