Navigation Links
The European Medicines Agency Validates and Accepts Cell Therapeutics' Marketing Authorization Application for Pixuvri™
Date:11/18/2010

SEATTLE, Nov. 18, 2010 /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that CTI's Marketing Authorization Application ("MAA") seeking approval for Pixuvri™ (pixantrone dimaleate) for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin's lymphoma ("NHL") was validated and accepted for review by the European Medicines Agency ("EMA"). Validation indicates that the application is complete and that the EMA's review process has begun.

"We look forward to working with our rapporteurs and the EMA during their review process in an effort to bring pixantrone to patients for whom there are currently no available drugs in this setting," said James A. Bianco, M.D., CEO of CTI.

The EMA's review of the MAA will follow the centralized marketing authorization procedure and, if the MAA is approved, Pixuvri expects to receive marketing authorization in the E.U. member states.

The Company also plans, in 2011, to submit a marketing application in selected other countries beginning with Switzerland.

Pixantrone was initially granted orphan drug status by the EMA for the treatment of diffuse large B-cell lymphoma (DLBCL), but based on the expansion of the current MAA to the broader aggressive NHL population, CTI has agreed to withdraw the orphan designation from the E.U. register.

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. We believe that these structural differences resulted in significantly enhanced anti-lymphoma activity compared to doxorubicin in preclinical models. In addition, we believe 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 http://www.celltherapeutics.com/.

Sign up for email alerts and get RSS feeds at CTI's 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 trading 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 and/or less toxic and effective for the treatment of relapsed or refractory, aggressive NHL and/or other tumors as determined by the EMA, that the EMA may not approve CTI's MAA after review, that Pixuvri may not prove effective as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive NHL, that CTI may not submit a marketing application in selected other countries in 2011, and 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/investorsMedical Information Contact:T: 800.715.0944E: info@askarm.com
'/>"/>

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

Related medicine technology :

1. CV Therapeutics Announces Eight Abstracts Accepted for Presentation at the European Society of Cardiology Congress 2007
2. Boston Scientific Announces Schedule for European Society of Cardiology Congress 2007
3. European Experts Recommend Pregnant and Nursing Women Take More DHA - Every Day
4. Genasense(R) Data in Melanoma to be Presented in Opening Session at First Worldwide Melanoma Center Meeting of the European Association of Dermato-Oncology
5. Terumo Heart to Announce Results of European Clinical Trial of DuraHeart(TM) LVAS at European Association of Cardiothoracic Surgeons Meeting in September
6. Threshold Pharmaceuticals Announces Two Presentations on Glufosfamide at the 2007 European Cancer Conference (ECCO)
7. Study Results for Aclidinium Bromide, a Novel Anticholinergic, Presented at European Respiratory Society Annual Congress
8. Life Recovery Systems Receives European CE Mark Approval for Its ThermoSuit(R) System
9. Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer
10. European Unions CHMP Issues Positive Opinion on PEGINTRON(TM) Combination Therapy for Retreating Hepatitis C Patients Who Failed Previous Therapy
11. Positive Xeloda(R) Five-Year Overall Survival Study Data in the Adjuvant Treatment of Colon Cancer Presented at Leading European Cancer Meeting
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/4/2017)... Centers for Disease Control and Prevention (CDC), influenza vaccination should take ... communities across Massachusetts , Connecticut , ... through the end of the month. *Some exclusions apply ... ... by the end of October, according to the Centers for Disease Control ...
(Date:10/2/2017)... , Oct. 2, 2017  AllianceRx Walgreens Prime, ... formed by Walgreens and pharmacy benefit manager Prime Therapeutics ... new brand, which included the unveiling of new signage ... , as well as at a few other company-owned ... new brand to patients, some of whom will begin ...
(Date:9/28/2017)... , Sept. 28, 2017 Cohen Veterans ... advance the use of wearable and home sensors for ... disorders. Early Signal Foundation, a nonprofit organization focused on ... will provide an affordable analytical system to record and ... ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... 2017 , ... The International Association of Eating Disorders Professionals ... the field of eating disorders, announces the opening of early registration for the ... at the Omni Resort at ChampionsGate. , The annual iaedp™ Symposium ...
(Date:10/13/2017)... ... October 13, 2017 , ... ... Randall, PharmD ‘17, and Jennifer Huggins, PharmD ’17, along with clinical associate ... primary prevention of cardiovascular diseases during the 15th Annual Women’s Health Conference. ...
(Date:10/13/2017)... (PRWEB) , ... October 13, 2017 , ... Apple ... care services, staged a mock evacuation of the facility as part of a disaster ... Fire Department, Echo Hose EMS and Shelton City Emergency Manager, as well as the ...
(Date:10/13/2017)... ... October 13, 2017 , ... The Visiting Nurse Association (VNA) of Somerset Hills ... specialty vendors and unique items from across the nation, this holiday-themed event will raise ... offered by the VNA. The boutique will be open Saturday, November 4 (10:00 ...
(Date:10/13/2017)... ... October 13, 2017 , ... Global Healthcare Management’s 4th Annual Kids Fun Run ... This free event, sponsored by Global Healthcare Management’s CEO, Jon Letko, is aimed ... geared towards children of all ages; it is a non-competitive, non-timed event, which is ...
Breaking Medicine News(10 mins):