Navigation Links
FDA's Office of New Drugs Meets With Cell Therapeutics on its Appeal on Pixantrone
Date:3/3/2011

SEATTLE, March 3, 2011 /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) today announced that it has met with officials of the FDA's Office of New Drugs ("OND") in Maryland and presented its arguments supporting the Company's belief that the data contained in its New Drug Application ("NDA") 22-481 support the conclusion that pixantrone is effective for its planned use.

"We appreciate OND's consideration of our appeal.  While we understand disputes of this type are a challenging process, we felt compelled to seek this review based on the PIX301 results and lack of approved therapies for these patients with an unmet medical need.  CTI is committed to the advancement of pixantrone," said James A. Bianco, M.D., CEO of CTI.

At the meeting, the OND requested additional analyses from the PIX301 Phase III clinical study.  CTI intends to submit the requested information and expects that this will reset the time period for OND to provide its decision on the appeal.  CTI anticipates a decision in the second quarter of 2011.

About PixantronePixantrone 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.

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 aggressive NHL and/or other tumors as determined by the FDA and/or the EMA, that the FDA may request additional clinical trials, 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, that CTI may not initiate a new clinical trial for pixantrone in 2011, that CTI cannot predict the outcome of the formal dispute resolution process, that the FDA may not make its decision on the appeal in the second quarter of 2011, that CTI's appeal may not be successful, that the EMA may not approve CTI's MAA after review, 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: 206.272.4343C: 206.854.1200E: deramian@ctiseattle.comwww.CellTherapeutics.com/press_roomInvestors Contact:Ed BellT: 206.282.7100Lindsey Jesch LoganT: 206.272.4347F: 206.272.4434E: invest@ctiseattle.comwww.CellTherapeutics.com/investors
'/>"/>

SOURCE Cell Therapeutics, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. PDL BioPharma Announces European Patent Office Determination of Validity of PDLs European Patent is Final
2. Thomas, McNerney & Partners Expands Team and Moves West Coast Office to San Diego
3. Masters Pharmaceutical, Inc. Appoints Wayne A. Corona to President and Chief Operating Officer
4. ERT Announces the Appointment of Eric Schwartz as Chief Legal Officer
5. Siemens Appoints Overhage as New Chief Medical Informatics Officer
6. Dr. Jeffrey Freitag Appointed Chief Medical Officer of PharmaNet
7. AVANIR Pharmaceuticals Appoints Gregory J. Flesher to Senior Vice President and Chief Business Officer
8. Orexigen® Therapeutics, Inc. Announces Upcoming Departure of Chief Financial Officer
9. Baxano, Inc. Names George A. Harter, Jr. as Chief Financial Officer
10. Arena Pharmaceuticals Announces Upcoming Departure of Chief Financial Officer
11. 3-V Biosciences Promotes Stephen R. Brady to Chief Business Officer
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/5/2016)... Dec. 5, 2016  New research by the ... Institute and the U.S. Department of Health and ... Preparedness and Response (ASPR), published online today in ... pharmacy notifications encourage patients with chronic conditions to ... The study also affirms that public-private partnerships can ...
(Date:12/5/2016)... Dec. 5, 2016  BD (Becton, Dickinson and Company) ... technology company, will demonstrate an enhanced technology platform designed ... including the company,s leading Pyxis™ and Alaris™ systems, at ... 2016 Midyear Meeting being held in ... While national data show that approximately 68 percent of ...
(Date:12/5/2016)... 5, 2016 Research and Markets has announced the ... Forecast to 2021" report to their offering. ... , , The global ... by 2021, at a CAGR of 5.3% from 2016 to 2021. Factors ... obesity cases, increasing government spending on healthcare, and rising income levels are ...
Breaking Medicine Technology:
(Date:12/5/2016)... ... , ... Sideline Products is a Southern York County Pennsylvania-based premier designer and ... the horse. Smaller saddles can pinch and irritate the horse creating safety issues and ... fitted western saddle so it does not impact the comfort or performance of the ...
(Date:12/5/2016)... ... December 05, 2016 , ... Airy Jeanine ... with prolific Songwriter-Producer Corey “Chorus” Gibson who has worked on hits by mega-artists ... a few.     https://twitter.com/coreychorus , The sessions taking place in North Jersey’s ...
(Date:12/5/2016)... ... , ... As renowned, board-certified dermatologists, Dr. Sabrina G. Fabi and Dr. Douglas ... not do their research and undergo cosmetic dermatology treatments from unqualified practitioners or worse, ... renaissance and every other month a new treatment or device is launched, promising everlasting ...
(Date:12/5/2016)... Columbus, OH (PRWEB) , ... December 05, 2016 ... ... novel engineering solution called the CardioQuick Patch® significantly improves the reproducibility and accuracy ... usability in various healthcare settings. , Over the last 60 years, studies ...
(Date:12/4/2016)... , ... December 03, 2016 , ... While James Earl ... serving as host for in a show called "Front Page". One of the forthcoming ... years, breast cancer rates have plummeted in large part due to early detection. Like ...
Breaking Medicine News(10 mins):