Navigation Links
European Regulatory Agency Supports OPAXIO(TM) Brand Name for Cell Therapeutics' Lung Cancer Drug
Date:5/4/2008

Important step toward commercialization: CTI selects OPAXIO(TM) as global

brand name to replace XYOTAX(TM)

SEATTLE, May 5 /PRNewswire-FirstCall/ -- Cell Therapeutics, Inc. (CTI) (Nasdaq: CTIC; MTA) today announced that it received a positive opinion from the European Medicines Agency (EMEA) for the brand name OPAXIO(TM) (paclitaxel poliglumex), which replaces XYOTAX(TM) as the brand name.

"We are pleased the EMEA has provided a favorable review of the OPAXIO brand name, which tested well in market research. This is a key step toward commercialization as we prepare for the potential introduction of this novel biologically enhanced chemotherapeutic in Europe, to establish OPAXIO as the global brand name for paclitaxel poliglumex," noted Jim Fong, Vice President of Commercial Operations at CTI.

In April, the EMEA accepted for review CTI's Marketing Authorization Application (MAA) for OPAXIO (paclitaxel poliglumex, CT-2103) for first-line treatment of patients with non-small cell lung cancer (NSCLC) with ECOG (Eastern Cooperative Oncology Group) performance status 2 (PS2). The EMEA's review process generally takes 15 to 18 months; if the MAA is approved by the EMEA at the end of its review, CTI will be authorized to begin selling OPAXIO in the European Union.

Lung cancer remains the biggest cancer killer in Europe. The incidence of lung cancer in Europe is more than 13 percent of all cancers, and in 2000 resulted in nearly 350,000 deaths.

About OPAXIO(TM)

OPAXIO(TM) (paclitaxel poliglumex, CT-2103), which was previously branded 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 http://www.CellTherapeutics.com.

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. Specifically, the risks and uncertainties that could affect the development of OPAXIO include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with OPAXIO in particular including, without limitation, risks that the OPAXIO brand name may be objected to at any time prior of after the potential granting of the marketing authorization, that the OPAXIO brand name may not be acceptable to other markets, including the U.S. market, where a request for regulatory approval may be submitted, marketing approval review of the OPAXIO MAA may not result in a marketing approval in Europe, determinations by regulatory, patent and administrative governmental authorities, competitive factors, technological developments, costs of developing, producing and selling OPAXIO in the various countries in Europe, and the risk factors listed or described from time to time in the Company's filings with the Securities and Exchange Commission including, without limitation, the Company's most recent filings on Forms 10-K, 8-K, and 10-Q. Except as may be required by Italian 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: media@ctiseattle.com

http://www.CellTherapeutics.com/media.htm

Investors Contact:

Leah Grant

T: 206.282.7100

F: 206.272.4434

E: invest@ctiseattle.com

http://www.CellTherapeutics.com/investors.htm


'/>"/>
SOURCE Cell Therapeutics, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. European EMEA Acceptance of Marketing Authorization Application Filing for SNT-MC17 in Friedreichs Ataxia by Santhera
2. ONCOSCIENCE AG, THE EUROPEAN PARTNER OF YM BIOSCIENCES, ANNOUNCES COMPLETION OF PATIENT ENROLLMENT IN PHASE III BRAIN CANCER TRIAL OF NIMOTUZUMAB
3. YM BIOSCIENCES, EUROPEAN PARTNER, ONCOSCIENCE AG, ANNOUNCES INITIATION OF ADVANCED NIMOTUZUMAB TRIALS IN ADULT GLIOMA AND PANCREATIC CANCER
4. Kline Study: Better Brushing Habits Boost European Oral Care Sales
5. Micromet, Inc. to Present at the Sal. Oppenheim 2nd European Healthcare Conference
6. European Centre for Modern Drug Discovery Established in Hamburg
7. SAFC Expands European Commercial Manufacturing and Storage Capacities With $10 Million Investment
8. Cardica Receives European CE Mark for C-Port Flex A System for Use in Coronary Artery Bypass Surgery
9. Biodel Inc. Announces VIAject(TM) Phase II Meal Study Data at the 2007 European Association for the Study of Diabetes Meeting
10. Intellect Neurosciences, Inc. Obtains Validation of European Patent for Alzheimers Vaccine in 19 Countries
11. Pharmion and MethylGene Announce Orphan Drug Designation Granted by the European Medicines Agency (EMEA) for MGCD0103 for the Treatment of Hodgkins Lymphoma
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... 27, 2016  Sequenom, Inc. (NASDAQ: SQNM ... lives through the development of innovative products and services, ... the United States denied its petition to ... of Sequenom,s U.S. Patent No. 6,258,540 (",540 Patent") are ... by the Supreme Court,s Mayo Collaborative Services v. Prometheus ...
(Date:6/27/2016)... Raleigh, NC (PRWEB) , ... June 27, 2016 ... ... a mission to bring innovative medical technologies, services and solutions to the healthcare ... development and implementation of various distribution, manufacturing, sales and marketing strategies that are ...
(Date:6/27/2016)... BOSTON , June 27, 2016   Ginkgo ... biology to industrial engineering, was today awarded as ... a selection of the world,s most innovative companies. ... at scale for the real world in the ... organism engineers work directly with customers including Fortune ...
(Date:6/24/2016)... , ... June 24, 2016 , ... While the majority ... as the Cary 5000 and the 6000i models are higher end machines that use ... height of the spectrophotometer’s light beam from the bottom of the cuvette holder. ...
Breaking Biology Technology:
(Date:4/28/2016)... 28, 2016 First quarter 2016:   ... compared with the first quarter of 2015 The gross ... M (loss: 18.8) and the operating margin was 40% (-13) ... Cash flow from operations was SEK 249.9 M (21.2) , ... is unchanged, SEK 7,000-8,500 M. The operating margin for ...
(Date:4/15/2016)... 2016  A new partnership announced today will ... decisions in a fraction of the time it ... high-value life insurance policies to consumers without requiring ... Force Diagnostics, rapid testing (A1C, Cotinine and HIV) ... pressure, weight, pulse, BMI, and activity data) available ...
(Date:3/31/2016)... 2016   LegacyXChange, ... "Company") LegacyXChange is excited to release its ... to be launched online site for trading 100% guaranteed ... will also provide potential shareholders a sense of the ... an industry that is notorious for fraud. The video ...
Breaking Biology News(10 mins):