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
'/>"/>

SOURCE Cell Therapeutics, Inc.
Copyright©2008 PR Newswire.
All rights reserved

4

GOOD

Page: 1 2 3

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:5/21/2013)... 2013  Synthetic Biologics, Inc. (NYSE MKT: SYN), a developer ... infectious diseases, announced today that Jeffrey Riley ... Marcum LLP MicroCap Conference on Thursday, May 30, 2013 in ... Hyatt Hotel. Mr. Riley is scheduled to present at 10:00 ... Biologics, presentation can be accessed by logging onto the web ...
(Date:5/21/2013)... 2013 Inflamax scientists worked closely ... to design the study, which will provide critical ... models used in the study of allergy treatments, ... Challenge (NAC) models. Although both the models are ... date no direct comparison between the allergic responses ...
(Date:5/21/2013)... The Formulate Fusion Fabric Display Kit ... marketing teams looking for a fully-functional package for their trade ... you’ll need to put together a stunning and eye-catching trade ... number of displays and accessories that can be quickly assembled ... feet in size. These components vary from kit to kit, ...
(Date:5/20/2013)... , May 20, 2013  MiMedx Group, Inc. (NASDAQ: ... marketer of patent protected regenerative biomaterials and bioimplants processed ... secured a revolving line of credit with Bank of ... secured by the Company,s accounts receivable and inventory, allows ... 1, 2014.  The facility will be used for general ...
Breaking Biology Technology:Synthetic Biologics to Present at the 2nd Annual Marcum LLP MicroCap Conference 2Inflamax Research selected by the Immune Tolerance Network and the National Institutes of Health to conduct a landmark clinical study on the underlying mechanisms of allergic inflammation. 2GLM Displays Announces All-in-One Formulate Fusion Fabric Display Kit 2
... April 27 Cellectricon, a leading,provider of ... announced,its collaboration with BioFocus DPI, a contract ... screening. BioFocus DPI will utilize,Cellectricon,s Dynaflow(R)HT, a ... increase its electrophysiology-based screening capacity, particularly,for fast ...
... SALEM, Mass., April 27 LaVoie Group, a life ... been selected as investor relations agency of record for ... of LaVoie Group, commented, "Pegasus has the opportunity to ... The Company is changing the standard of care ...
... MISSISSAUGA, ON, April 24 /PRNewswire-FirstCall/ - Vasogen Inc. (NASDAQ: ... will succeed Terrance H. Gregg as Chairman of its Board ... Gregg,s resignation from Vasogen,s Board is due to the requirements ... , Dr. Smith, a Vasogen Board member since 1998, is ...
Cached Biology Technology:Cellectricon and BioFocus DPI Advance High Throughput ion Channel Drug Discovery 2LaVoie Group Adds Bio-Surgery Company, Pegasus Biologics, to Its Life Sciences Agency Roster 2Vasogen Appoints Dr. Eldon Smith Chairman 2Vasogen Appoints Dr. Eldon Smith Chairman 3
(Date:5/21/2013)... -- Over the past few decades, scientists have developed ... balloons and metallic stents. While generally effective, each of ... effects. , A new study from MIT analyzes the ... benefits of angioplasty balloons and drug-releasing stents, but may ... is inflated in the artery for only a brief ...
(Date:5/21/2013)... modifications, which alter the way genes function without ... detected in the blood of pregnant women during ... foretell depression in the weeks after giving birth, ... debilitating. , The findings of the small study ... the journal Molecular Psychiatry . , "Postpartum ...
(Date:5/20/2013)... The Amazon rain forest, popularly known as the lungs of ... use carbon dioxide from the air to grow parts that ... away by the region,s plentiful rainfall. , Until recently ... the Amazon River and ended up deep in the ocean. ... exhale huge amounts of carbon dioxide though left open ...
Breaking Biology News(10 mins):Evaluating a new way to open clogged arteries 2Evaluating a new way to open clogged arteries 3Genetic predictors of postpartum depression uncovered by Hopkins researchers 2Genetic predictors of postpartum depression uncovered by Hopkins researchers 3Amazon River exhales virtually all carbon taken up by rain forest 2Amazon River exhales virtually all carbon taken up by rain forest 3
... screening significantly extend the time of goods at port. ... screening and detection systems. At the same time, increased ... access control systems in ports and entry points. , ... New analysis from Frost & Sullivan ( http://www.aerospace.frost.com ), ...
... Eight supply chain professionals were elected in June by the ... the seven existing members of SCC,s board. Newly elected board members, ... as follows: , , , , ... Hewlett Packard , Jane Barrett, Research ...
... , , LONDON, July 10 IBM (NYSE: IBM ... of the UK Home Office, have signed a seven-year agreement for IBM ... biometric passports and enhance the security of the UK border. IBM ... and Asylum Fingerprint System (IAFS) which holds biometrics collected from visa applicants. ...
Cached Biology News:Growing Demand for Rapid Screening and Detection Systems Pushes the European Maritime Security Market, Finds Frost & Sullivan 2Growing Demand for Rapid Screening and Detection Systems Pushes the European Maritime Security Market, Finds Frost & Sullivan 3UK Identity and Passport Service and IBM Sign 7-year National Biometric Identity Service (NBIS) Contract 2
Compound(s) tested through a broad panel of 38 ligand binding and enzyme assays targeting the Central Nervous System. Used to determine selecitivty and potential CNS-Side Effect liabilities of compo...
... the basic components and protocol required ... plates for quantitation of a specific ... culture supernate. Every Screening Set contains ... (5 individual standards), Streptavidin-HRP, TMB Substrate ...
... The organic acid analysis ... of six organic salts; molecular ... 294. This standard is provided ... HPX-87H column and the organic ...
... The RapidVUE is a particle shape and size ... been designed with the utmost simplicity in mind. ... delivery module and an optical bench. The system ... for easy upgrade for different applications such as ...
Biology Products: