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|Cell Therapeutics Resubmits Pixantrone NDA to FDA for Consideration of Accelerated Approval|
SEATTLE, Oct. 25, 2011 /PRNewswire via COMTEX/ -- Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC) today announced that it has resubmitted the pixantrone New Drug Application ("NDA") to the U.S. Food and Drug Administration's ("FDA") Division of Oncology Drug Products ("DODP") for accelerated approval to treat relapsed or refractory aggressive non-Hodgkin's lymphoma ("NHL") in patients who failed two or more lines of prior therapy.
CTI had appealed the FDA's Complete Response Letter for the pixantrone NDA based on the results of the PIX301 clinical trial. In May 2011, the FDA's Office of New Drugs ("OND") responded to CTI's appeal recommending that CTI conduct an additional review of radiographs utilizing a new independent panel of radiologists to confirm the response and progression events noted in the pixantrone NDA in order to determine that efficacy had been established. CTI recently announced that a second independent radiology assessment of response and progression endpoint data confirmed the statistical robustness of the PIX301 efficacy data contained in the NDA.
In June 2011, CTI met with the DODP to review its plans for responding to the items noted in the Complete Response Letter ("CRL"), as well as its plans for addressing the items noted by the OND in response to the appeal. The Company believes the information contained within the resubmitted NDA adequately addresses the recommendations from the OND and items noted in the CRL.
"We believe the resubmitted NDA not only addresses the items in the Complete Response Letter, but confirms the reliability of the initial efficacy results, which we believe demonstrates that pixantrone does provide a clinical benefit to this patient population for which there are no currently approved therapies," said James A. Bianco, M.D., CEO of CTI.
The DODP previously confirmed that the review of the NDA would be completed within six months from the date of resubmission, which should provide CTI an FDA action date by April 2012.
Pixantrone is also under review for approval in Europe. The Company expects to receive its day 180 responses from the European Medicines Agency (the "EMA") in this quarter.
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 in an effort 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 diffuse large 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.comhttp://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 NHL and/or other tumors as determined by the FDA and/or the EMA, that accelerated approval by the FDA of pixantrone may not occur, that CTI may not be able to address satisfactorily the two key matters raised by the OND or other matters raised by the DODP, the OND and/or the FDA, that CTI's interpretation of the guidance provided by the OND, the DODP and/or the FDA may be different than the intent of the OND, the DODP and/or the FDA, that the OND, the DODP and/or the FDA may change its guidance, that the PIX301 study may not be deemed successful, that upon a re-review and/or resubmission of the NDA the FDA may find pixantrone to not be safe and/or effective, that the PIX301 study may still be deemed to be a failed study, that the FDA may require an additional clinical trial of pixantrone, that if CTI conducts an additional clinical trial, it may not demonstrate the safety and effectiveness of pixantrone, that CTI may not be able to provide satisfactory information in response to the FDA's Complete Response Letter, that the FDA may not complete the review of the NDA within six months of resubmission, that CTI may not obtain an FDA action date by April 2012, that CTI may not receive its 180 day responses from the EMA in the fourth quarter of 2011, that CTI may not obtain approval of the NDA from the FDA in the first half of 2012, 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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SOURCE Cell Therapeutics, Inc.