Navigation Links
FDA Sets Action Date of April 23, 2010 for Review of Pixantrone NDA
Date:9/5/2009

SEATTLE, Sept. 5 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that the U.S. Food and Drug Administration (FDA) has notified CTI that a Prescription Drug User Fee Act (PDUFA) action date of April 23, 2010 under standard review has been established regarding CTI's NDA for pixantrone as potential treatment for relapsed or refractory aggressive non-Hodgkin's lymphoma (NHL). Pixantrone has fast track designation for the relapsed / refractory aggressive NHL application.

"The 18 month follow up PIX 301 pivotal trial data continues to demonstrate further improvement in primary and secondary endpoints including Complete Remission / Complete Remission unconfirmed(CR/CRu), Progression Free Survival (PFS) and Overall Survival over standard chemotherapy. We look forward to providing the four month safety and efficacy update to the FDA and working with them toward potential approval," said James A. Bianco, M.D., Chief Executive Officer of CTI.

Based on the user fee goal date, if pixantrone is approved, CTI estimates that pixantrone could be available to patients in the U.S. early in the second quarter of 2010.

About Pixantrone

Pixantrone (BBR 2778), is a novel topoisomerase II inhibitor with an aza-anthracenedione molecular structure that differentiates it from the anthracyclines and other related chemotherapy agents. Anthracyclines are the cornerstone therapeutic for the treatment of lymphoma, leukemia, and breast cancer. Although they are sufficiently effective to be used as first-line (initial) treatment, they cause cumulative heart damage that may result in congestive heart failure many years later. As a result, there is a lifetime limit of anthracycline doses and most patients who previously have been treated with an anthracycline are not able to receive further anthracycline treatment if their disease returns.

About Fast Track

Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious diseases and fill an unmet medical need. Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially superior to existing therapy.

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_news.htm

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 our 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 as determined by the FDA, and that a decision by the FDA is not rendered by April 23, 2010, and that pixantrone may not be available to patients in the second quarter of 2010, the possibility that the follow-up data does not demonstrate continued improvement in the primary and secondary endpoints, 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
    www.CellTherapeutics.com/media.htm

    Investors Contact:
    Ed Bell
    T: 206.282.7100
    Lindsey Jesch
    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©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Real-World Study Showed Cost Savings for VTE Prophylaxis with Enoxaparin Compared with Unfractionated Heparin (UFH)
2. Mars, Incorporated Commits Over $2 Million to Federal Agency for Human-Animal Interaction Research
3. Shire Reports Positive Results From First of Three Phase III Trials of velaglucerase alfa for Type 1 Gaucher Disease and Provides Important Updates on Interactions With FDA
4. Novel Valortim(R) Mechanism of Action Data Presented at the Keystone Symposia on Molecular and Cellular Biology
5. Shareholder Class Action Filed Against Rigel Pharmaceuticals, Inc. by the Law Firm of Barroway Topaz Kessler Meltzer & Check, LLP
6. ASGE and The Pancreatic Cancer Action Network Partner to Raise Awareness About Pancreatic Cancer
7. Nebulized Perforomist(TM) Inhalation Solution Provided Prolonged Bronchodilation and Increased Patient Satisfaction Compared to Albuterol/Ipratropium MDI
8. APTA Supports Surgeon Generals Call to Action to Prevent Deep Vein Thrombosis and Pulmonary Embolism
9. Surgeon Generals Call to Action to Prevent DVT/PE Praised by NATT as Turning Point
10. U.S. FDA Issues Action Letter for Sugammadex
11. Medivation Presents Positive New Data on Dimebons Long-Term Efficacy and Novel Mechanism of Action at the International Conference on Alzheimers Disease
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/23/2017)... PLEASANTON, Calif. , May 23, 2017 /PRNewswire/ ... world,s most innovative medical devices for pressure ulcer ... at the American Association of Critical Care Nurses, ... Houston May 22-25. The Leaf Patient ... designed specifically for the hospital environment.  The system ...
(Date:5/22/2017)... MAITLAND, Fla. , May 22, 2017 /PRNewswire/ ... industry as a whole continue to make the ... evidence becomes increasingly important for ensuring positive patient ... Key industry stakeholders are shifting focus away from ... results and effects of long-term specialty drug therapy ...
(Date:5/18/2017)... May 17, 2017  Bayer announced today that the ... be presented at the 53 rd Annual Meeting ... place June 2-6 in Chicago . ... span prostate, colorectal, liver and thyroid cancers, as well ... Phase II CHRONOS-1 trial of copanlisib in patients with ...
Breaking Medicine Technology:
(Date:5/24/2017)... ... 24, 2017 , ... Medic CE , a Career Step company, is ... Shock” hosted by the Journal of Emergency Medical Services (JEMS). The free webinar, to ... presented by Captain Rommie Duckworth, LP, a career fire captain as well as founder ...
(Date:5/24/2017)... ... May 24, 2017 , ... Rob Lowe is a sought after actor, and ... “Informed” brings the public important topics from all aspects of life, and a new ... issues surrounding feet and ankles. , Podiatry is essential to people’s overall well-being, and ...
(Date:5/24/2017)... ... May 24, 2017 , ... ... based sleep diagnostics sensors, announced today it had completed the first phase of ... mix of domestic and rest of world (ROW) authorized dealers specializing in polysomnography ...
(Date:5/23/2017)... (PRWEB) , ... May 23, 2017 , ... ... the pharmaceutical and medical device sectors, today announced the winners of its 3rd ... Entrepreneurs) represent the most influential people in the healthcare industry today. , Out ...
(Date:5/23/2017)... ... ... The National Council on Strength and Fitness (NCSF), a ... Strength Coach credential has earned accreditation from the National Commission for Certifying Agencies ... qualified candidates for jobs in the Strength and Conditioning profession. The CSC distinction ...
Breaking Medicine News(10 mins):