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|Cell Therapeutics Completes Type A Meeting With FDA's Division of Oncology Drug Products: Guidance Provided for Resubmission of Pixantrone NDA for Consideration of Accelerated Approval|
- Received guidance on information needed for resubmission and approaches to address items in complete response letter
- Confirmed 6 month review time from submission
SEATTLE, June 14, 2011 /PRNewswire via COMTEX/ --
Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC) today announced that it met with the U.S. Food and Drug Administration's (the "FDA") Division of Oncology Drug Products (the "DODP"). The meeting provided a pathway for re-submitting CTI's New Drug Application (the "NDA") for pixantrone for relapsed or refractory aggressive non-Hodgkin's lymphoma ("NHL") including the potential for accelerated approval based on the PIX301 study results. This meeting follows CTI's receipt of the FDA's Office of New Drugs' (the "OND") response to CTI's appeal as announced on May 3, 2011, which allows CTI the opportunity to resubmit the NDA. On appeal, the FDA recommended the Company 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. The DODP meeting also focused on the documents CTI proposed to provide regarding the circumstances of stopping the enrollment of the clinical trial prior to achieving the original planned patient accrual and the make-up of the new radiology expert panel. CTI also plans to address items noted in the FDA's Complete Response Letter. The DODP confirmed that the NDA would be reviewed within six months from the resubmission of the NDA. CTI anticipates filing the additional information later this year, and could obtain FDA approval in the first half of 2012.
"We are pleased to have the opportunity to meet with the review team from the DODP and to get their feedback on what will be required for a resubmission of our pixantrone NDA. We now have a pathway to move forward with resubmitting the NDA for potential accelerated approval of pixantrone in patients with multiple relapsed or refractory aggressive NHL, which is a stage of this disease for which there are no approved agents," stated Jack W. Singer, M.D., Chief Medical Officer of CTI. "We are excited to have been given this rare second opportunity for review of the NDA and we have made this resubmission our top priority."
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.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 European Medicines Agency, that accelerated approval by the FDA of pixantrone may not be possible or 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 and/or the DODP may be different than the intent of the OND and/or the DODP, that the OND and/or the DODP may change its guidance, that the PIX301 study may not be deemed successful, that upon a re-review 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 CTI may not be able to re-submit the pixantrone NDA quickly, that CTI may not be able to fill the additional information for the NDA later this year, 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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