PixuvriTreatment for non-Hodgkin's Lymphoma
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
SEATTLE, June 14, 2011 /PRNewswire/ -- Cell Therapeutics, Inc. 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.
Lindsey Jesch Logan
Medical Information Contact:
SOURCE Cell Therapeutics, Inc.
Web Site: http://www.celltherapeutics.com
Posted: June 2011
- Cell Therapeutics Withdraws New Drug Application for Pixuvri and Plans to Resubmit in 2012 - January 30, 2012
- FDA's Oncologic Drugs Advisory Committee to Review Resubmitted Pixantrone New Drug Application on February 9, 2012 - January 3, 2012
- FDA Sets April 24, 2012 as PDUFA Goal Date for Cell Therapeutics' Resubmitted Pixantrone New Drug Application - December 6, 2011
- Cell Therapeutics Resubmits Pixantrone NDA to FDA for Consideration of Accelerated Approval - October 25, 2011
- FDA Sets Meeting Date in Early June to Discuss Re-submission of Pixantrone NDA for Accelerated Approval - May 20, 2011
- Cell Therapeutics to Re-submit Pixantrone NDA in Consideration for Accelerated Approval in Accordance with Guidance from FDA's Office of New Drugs - May 3, 2011
- Cell Therapeutics Files Appeal on FDA Decision on New Drug Application (NDA) for Pixantrone to Treat Relapsed/Refractory Aggressive Non-Hodgkin's Lymphoma - December 3, 2010
- Cell Therapeutics to Appeal FDA Decision on New Drug Application (NDA) for Pixantrone to Treat Relapsed/Refractory Aggressive Non-Hodgkin's Lymphoma - September 14, 2010
- CTI Receives Complete Response Letter from the FDA for Pixantrone NDA; CTI to File for Expanded Access for Patients With Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma - April 9, 2010
- CTI Provides Update on FDA Advisory Committee Meeting on Pixantrone for the Treatment of Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma - March 22, 2010
- FDA Sets March 22 for ODAC Meeting to Review CTI's New Drug Application for Pixantrone - March 2, 2010
- FDA Postpones Oncologic Drugs Advisory Committee Meeting to Review Pixantrone Due to Severe Weather Conditions - February 9, 2010
- Cell Therapeutics Announces FDA's Oncologic Drugs Advisory Committee to Review Pixantrone for the Treatment of Relapsed/Refractory Aggressive Non-Hodgkin's Lymphoma, February 10, 2010 - December 17, 2009
- FDA Sets Action Date of April 23, 2010 for Review of Pixantrone NDA - September 6, 2009
- FDA Accepts to File Cell Therapeutics' New Drug Application for Pixantrone - August 26, 2009
- Cell Therapeutics Completes Pixantrone NDA Submission and Requests Priority Review - June 24, 2009
- Cell Therapeutics Initiating Rolling NDA Submission For Pixantrone - April 14, 2009