Navigation Links
FDA Sets April 24, 2012 as PDUFA Goal Date for Cell Therapeutics' Resubmitted Pixantrone New Drug Application
Date:12/6/2011

SEATTLE, Dec. 6, 2011 /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC) today announced that the U.S. Food and Drug Administration's ("FDA") Division of Oncology Products 1 ("DOP1") has notified CTI that CTI's October 2011 resubmitted New Drug Application ("NDA") is considered a complete, Class 2 response to the FDA's April 2010 complete response letter ("CRL"). The FDA has set a Prescription Drug User Fee Act ("PDUFA") goal date of April 24, 2012 for a decision on the NDA.   The NDA seeks accelerated approval of pixantrone to treat relapsed or refractory aggressive non-Hodgkin's lymphoma ("NHL") in patients who failed two or more lines of prior therapy.

Pixantrone is also under review for marketing approval in Europe with a Committee for Human Medicinal Products ("CHMP") opinion on the application tentatively scheduled on January 19, 2012.

"We look forward to working with the FDA and the European Medicines Agency ("EMA") to bring this drug to patients for whom there are currently no approved therapies," James A. Bianco, M.D. Chief Executive Officer stated.

CTI appealed the CRL for the pixantrone NDA based on the results of the PIX301 clinical trial. The FDA's Office of New Drugs ("OND") responded to CTI's appeal by providing CTI with an opportunity to resubmit the NDA with additional information, but without conducting an additional clinical trial. In June 2011, CTI met with the DOP1 to review CTI's plans for responding to the items noted in the CRL including CTI's plans for addressing the items noted by the OND in response to the appeal.

About Pixantrone

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 http://www.CellTherapeutics.com.

Sign up for email alerts and get RSS feeds at our Web site, http://www.CellTherapeutics.com/investors_alert

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 DOP1, the OND and/or the FDA, that CTI's interpretation of the guidance provided by the OND, the DOP1 and/or the FDA may be different than the intent of the OND, the DOP1 and/or the FDA, that the OND, the DOP1 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 CRL, that the FDA may not complete the review of the NDA by the PDUFA goal date of April 24, 2012, that the CHMP may not render an opinion on CTI's application for pixantrone with the EMA by January 19, 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.

Media Contact:

Dan Eramian
T: 206.272.4343
C: 206.854.1200
E: deramian@ctiseattle.com

Investors Contact:

Ed Bell
T: 206.272.4345
Lindsey Jesch Logan
T: 206.272.4347
F: 206.272.4434
E: invest@ctiseattle.com
www.CellTherapeutics.com/investors

Medical Information Contact:

T: 800.715.0944
E: info@askarm.com


'/>"/>
SOURCE Cell Therapeutics, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Alseres Pharmaceuticals, Inc. to Address a Congressional Briefing on Paralysis Research and the Spinal Cord Injury Community at Working 2 Walk in Washington, DC, April 13-15, 2008
2. ViroPharma to Release 2008 First Quarter Financial Results on April 30, 2008
3. April 16th Congressional Hearing on Hospital Infections
4. The COSHAR Foundation Launches National Childhood Immunization Awareness Campaign During National Infant Immunization Week (April 19-26)
5. PharmAthene to Host a Conference Call and Webcast on Wednesday, April 29th at 4:30 PM to Provide an Update on the SparVax(TM) rPA Anthrax Vaccine Program
6. FDA Sets Action Date of April 23, 2010 for Review of Pixantrone NDA
7. 2nd Annual Orthopedic Design & Technology Forum Returns April 28 to the FedEx Institute of Technology, University of Memphis
8. Stryker to Host Conference Call on April 20, 2010
9. FDA Consumer Health Information - Generic Drug Roundup: April 2010
10. United Therapeutics Corporation To Announce First Quarter 2010 Financial Results Before Market Open on Thursday, April 29, 2010
11. CardioGenics to be Spotlighted in Three Publications During Month of April
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/24/2017)...   The Accreditation Council for Medical Affairs ... the pharmaceutical industry has appointed Dr. Jane ... formed scientific advisory board. Dr. Chin will be ... ever medical affairs think tank within the pharmaceutical ... ACMA, please visit  www.medicalaffairsspecialist.org .  Connect with ...
(Date:3/24/2017)... , Mar. 24, 2017 Research and Markets ... Pipeline Analysis, 2016" report to their offering. ... The IPF pipeline is very strong with a ... Merck & Co., Inc., Biogen and Sanofi are involved in the development ... of which one is in Phase III stage, 15 are in Phase ...
(Date:3/24/2017)... March 24, 2017 Today Stock-Callers.com have ... which are: Neovasc Inc. (NASDAQ: NVCN), Hologic Inc. (NASDAQ: HOLX), ... SSH ). These companies are part of the ... on Thursday, March 23 rd , 2017, with the NYSE ... of health care companies in the S&P 500 were down ...
Breaking Medicine Technology:
(Date:3/24/2017)... NY (PRWEB) , ... March 24, 2017 , ... ... scale; from third world countries to hospitals in the United States, it’s a ... conversation on the current obstacles facing infection prevention and offers strategies for the ...
(Date:3/24/2017)... ... March 24, 2017 , ... According to a new study by NCPA ... does not obey the rules Congress has directed the CBO to follow. The CBO ... reform would restore. Yet, it estimates a reduction in employer-based coverage due to the ...
(Date:3/24/2017)... , ... March 24, 2017 , ... ... planning, and related services to families and business owners across eastern Michigan, is ... feeding regional families struggling with financial difficulties. , The Oxford/Orion FISH Food Pantry ...
(Date:3/24/2017)... , ... March 24, 2017 , ... ... Society (ONS) wanted to create a communications platform that positions them as the ... Elliance and ONS reinvented their online publication as an always-on, always-fresh news, views ...
(Date:3/24/2017)... Westchester County, NY (PRWEB) , ... March 24, 2017 , ... ... in Somers and White Plains, N.Y., is pleased to announce Westchester resident Lauren C. ... as a law clerk for the firm, will concentrate her practice in elder law, ...
Breaking Medicine News(10 mins):