Navigation Links
European Medicines Agency (EMEA) Approves Cell Therapeutics, Inc.'s September Meeting Request to Discuss OPAXIO(TM) Marketing Authorization Application

SEATTLE, July 7 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. ("CTI") (Nasdaq and MTA: CTIC) announced today that it had requested and the EMEA has agreed to an oral explanation in support of the OPAXIO Marketing Authorization Application (MAA) in September, 2009 extending the review for the Committee for Medicinal Products for Human Use (CHMP) opinion on approval until Q4-2009. In April, 2008 the EMEA accepted for review the MAA for OPAXIO for first-line treatment of patients with advanced non-small cell lung cancer who are performance status 2, based on a non-inferior survival and improved side effect profile. The previously scheduled June, 2009 meeting with the EMEA on OPAXIO did not occur due to conflicts in regulatory schedule as CTI focused on completing the pixantrone New Drug Application (NDA) submission in June, 2009.

"We are pleased that the EMEA has agreed to an in person oral explanation in September allowing the Company and its lung cancer experts adequate time to prepare a thorough review for the Co-rapporteurs in support of our MAA for OPAXIO in non-small cell lung cancer," said James A. Bianco, M.D., CEO of Cell Therapeutics. "The fourth quarter is shaping up to be a pivotal period for the Company."


OPAXIO(TM) (paclitaxel poliglumex, CT-2103), which was formerly known as XYOTAX(TM), is an investigational, biologically enhanced, chemotherapeutic that links paclitaxel, the active ingredient in Taxol(R), to a biodegradable polyglutamate polymer, which results in a new chemical entity. When bound to the polymer, the chemotherapy is rendered inactive, potentially sparing normal tissue's exposure to high levels of unbound, active chemotherapy and its associated toxicities. Blood vessels in tumor tissue, unlike blood vessels in normal tissue, are porous to molecules like polyglutamate. Based on preclinical studies, it appears that OPAXIO is preferentially distributed to tumors due to their leaky blood vessels and trapped in the tumor bed allowing significantly more of the dose of chemotherapy to localize in the tumor than with standard paclitaxel. Once inside the tumor cell, enzymes metabolize the protein polymer, releasing the paclitaxel chemotherapy. Preclinical and clinical studies support that OPAXIO metabolism by lung cancer cells may be influenced by estrogen, which could lead to enhanced release of paclitaxel and efficacy in women with lung cancer compared to standard therapies.

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

Sign up for email alerts and get RSS feeds at our Web site,

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 include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general, and with OPAXIO and pixantrone in particular, including, without limitation, the potential for OPAXIO and pixantrone to be proved safe and effective the treatment of the indications noted in this press release or any other indication, determinations by regulatory, patent and administrative governmental authorities (including the FDA and EMEA), CTI's ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, and costs of developing, producing and selling OPAXIO and pixantrone, CTI's ability to sell OPAXIO and pixantrone and otherwise receive any revenue 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

    Investors Contact:
    Ed Bell
    T: 206.282.7100
    Lindsey Jesch
    T: 206.272.4347
    F: 206.272.4434

SOURCE Cell Therapeutics, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine news :

1. Eligard(R) six-month formulation successfully completes European approval procedure
2. Innocoll Agrees the Sale of its CollaRx(R) GENTAMICIN SURGICAL IMPLANT and European Sales and Marketing Infrastructure to EUSA Pharma
3. Medical Services International Inc. Completes Testing for European Union (EU) Application
4. Labopharm To Present Poster On Onset Of Analgesic Effect Of Once-Daily Tramadol At Congress Of The European Society Of Regional Anaesthesia And Pain Therapy
5. Amylin Pharmaceuticals to Webcast Corporate Overview During 43rd Annual Meeting of the European Association for the Study of Diabetes
6. Launch of second European Cancer Research Funding survey
7. European directive will halt use of MRI scans; cancer diagnosis and treatment will suffer
8. Pharsight to Host European Software Conference
9. OmniGuide Begins European Commercialization
10. Paving the way for future pan-European clinical trials
11. US, European cancer educators gather in Alabama for meeting
Post Your Comments:
(Date:10/13/2017)... ... October 13, 2017 , ... ... communities in the greater Dallas, Miami, and Raleigh regions, is organizing an extended ... overcome a rare and deadly chromosome abnormality. , After struggling since birth with ...
(Date:10/13/2017)... ... 13, 2017 , ... While it’s often important to take certain medications during ... Austin, Texas, has identified a solution. , She developed a prototype for MOTION LIGHT-UP ... such, it eliminates the need to turn on a light when taking medication during ...
(Date:10/13/2017)... ... October 13, 2017 , ... PurhealthRX , a leading ... Purzorb™ technology. Applying the Purzorb™process to full spectrum CBD oil will revolutionize the rapidly ... CBD form that can be easily incorporated into liquid products, while reducing costs to ...
(Date:10/13/2017)... ... October 13, 2017 , ... Apple Rehab Shelton Lakes , which specializes ... of the facility as part of a disaster drill on October 3rd. , Apple ... Shelton City Emergency Manager, as well as the Connecticut Long Term Care Mutual ...
(Date:10/13/2017)... ... 2017 , ... Ellevate Network, the leading network for professional women, brought together ... equality at their inaugural Summit in New York City in June. The event was ... of over 3 million. To watch the Mobilize Women video, click here . ...
Breaking Medicine News(10 mins):
(Date:10/2/2017)... 2017 Halo Labs announces the European launch of their ... HORIZON at MIBio 2017 in Cambridge, U.K ... matter in biopharmaceutical samples with unprecedented speed and sensitivity while using ... Backgrounded Membrane Imaging. ... subvisible particle analysis system ...
(Date:9/28/2017)... Cohen Veterans Bioscience and Early Signal Foundation announce a ... sensors for real-time monitoring of patients with trauma-related and ... focused on disruptive health solutions for rare disorders and ... record and integrate behavioral, cognitive, physiological and contextual data. ... ...
(Date:9/25/2017)... , Sept. 25, 2017   Montrium ... Master File solutions, today—from the IQPC Trial Master ... , NL)—announced that EastHORN Clinical Services has ... clinical programs and TMF management. EastHORN, a leading ... eTMF platform to increase transparency to enable greater ...
Breaking Medicine Technology: