Navigation Links
European Medicines Agency (EMEA) Approves Cell Therapeutics, Inc.'s September Meeting Request to Discuss OPAXIO(TM) Marketing Authorization Application
Date:7/6/2009

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."

About OPAXIO(TM)

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 du
'/>"/>

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

Page: 1 2 3

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:
*Name:
*Comment:
*Email:
(Date:4/25/2015)... 2015 The URO CENTER of NEW YORK ... chosen by the New York Academy of Medicine to receive ... the field of Urology. , Dr. Ferdinand Valentine, born in ... diseases. He was a man of rare and attractive ... Not only did he devote his life to his ...
(Date:4/24/2015)... Constellations Recovery celebrates the opening of ... Just 35 miles from New York City, Constellations Recovery ... life while recovering from addiction. The Open House, which ... therapists, doctors and treatment centers to see the residence, ... opportunities offered by Constellations Recovery.,  , The newly opened ...
(Date:4/24/2015)... April 24, 2015 The Fastest Fat Loss ... their great success of the Xtreme Fat Loss Diet, has ... The fat loss blueprint that claims to help one lose ... of HealthyandFitZone.com's Stan Stevenson, prompting an investigative review. , "Our ... the creators spent years researching and experimenting with these methods ...
(Date:4/24/2015)... Lowcostcarinsuranceprice.com has released a new blog post explaining how ... citizens . , Senior citizens may be considered ... they cannot find affordable coverage. By comparing online auto ... coverage for their cars at the best prices. ... provides free leads from various agencies that are in ...
(Date:4/24/2015)... “Kind,” “selfless,” “the voice of reason” and ... Weiner described pediatric oncology nurse Laura Vasquez of Children’s ... during her five-year battle with a malignant brain tumor. ... and numerous experimental treatments, Vasquez continued caring for Alexa, ... was not in the hospital and even sitting vigil ...
Breaking Medicine News(10 mins):Health News:The 2015 Valentine Award Comes From The Heart and Goes To Famous New York Urologist 2Health News:The 2015 Valentine Award Comes From The Heart and Goes To Famous New York Urologist 3Health News:Constellations Recovery Opens The First Luxury Sober Living Residence in Westchester New York 2Health News:Constellations Recovery Opens The First Luxury Sober Living Residence in Westchester New York 3Health News:Fastest Fat Loss Week Ever Review Revealed on Healthy & Fit Zone 2Health News:Low Cost Auto Insurance Quotes for Senior Citizens 2Health News:CURE™ Magazine Names Pediatric Nurse Laura Vasquez from Children’s Hospital Los Angeles As Extraordinary Healer™ of 2015 2Health News:CURE™ Magazine Names Pediatric Nurse Laura Vasquez from Children’s Hospital Los Angeles As Extraordinary Healer™ of 2015 3Health News:CURE™ Magazine Names Pediatric Nurse Laura Vasquez from Children’s Hospital Los Angeles As Extraordinary Healer™ of 2015 4
... New web-based research has quantified the attractiveness of the ... features of one woman into 243 variations with differing ... widths. Then more than 34,000 people judged the attractiveness ... the same in all of the photos, researchers found ...
... Old Republic International Corporation (NYSE: ORI ... the payment of the regular quarterly cash dividend of 17 ... March 13, 2009 to shareholders of record on March 4, ... rate initially approved for the second quarter of 2008. ...
... as Asian AffiliateNEW YORK and SINGAPORE, Feb. 26 ... prevention services, has signed an affiliation agreement with ... group based in Singapore and a subsidiary of ... medicine programs throughout Asia. Under the agreement, ParkwayHealth ...
... 274 adults with intellectual disabilities currently receiving funding ... , Washington, DC(February 23, 2009)The Supports Intensity ... for people with intellectual disability based on individual ... tool, unlike adaptive behavior instruments or other measures ...
... at the UCSF-Gladstone Institute for Virology and Immunology Center ... development of the next generation of HIV/AIDS researchers and ... published in the American Journal for Public Health ... of the AJPH website, the program focuses on overcoming ...
... Abbott ( NYSE: ABT ),today announced that it has ... now a wholly owned subsidiary of Abbott and has been,renamed ... acquisition of AMO enhances and strengthens Abbott,s diverse mix of,medical ... large and,growing eye care market. Abbott Medical Optics holds ...
Cached Medicine News:Health News:Plastic and reconstructive surgery ... in brief 2Health News:U.S. Preventive Medicine(R), ParkwayHealth Sign Affiliation Agreement to Jointly Deliver Preventive Medicine Services in Asia 2Health News:U.S. Preventive Medicine(R), ParkwayHealth Sign Affiliation Agreement to Jointly Deliver Preventive Medicine Services in Asia 3Health News:Supports Intensity Scale is effective for identifying needs in people with intellectual disability 2Health News:Effective mentoring critical to HIV/AIDS research efforts 2Health News:Abbott Completes Acquisition of Advanced Medical Optics 2
(Date:4/23/2015)... NORTH CHICAGO, Ill. , April 24, 2015 /PRNewswire/ ... U.S. Food and Drug Administration (FDA) has accepted its ... the company,s, all-oral, interferon-free, two direct-acting antiviral treatment of ... is for the treatment of adults with chronic genotype ... AbbVie,s regimen is the first all-oral, interferon-free therapy being ...
(Date:4/23/2015)... 2015 /CNW/ - Health Canada is working with the ... the safety information regarding the risk of serious cardiovascular ... products are used at high doses (at or above ... of use. Ibuprofen is a non-steroidal anti-inflammatory ... to reduce inflammation. The majority of ibuprofen products in ...
(Date:4/23/2015)... , Apr. 23, 2015 Surna, Inc. ... and distributes state-of-the art equipment and systems for ... commercial indoor cannabis cultivation, will host a shareholder ... April 27, 2015, at 4:15 PM Eastern Standard ... The conference call will be listen-in only, but ...
Breaking Medicine Technology:U.S. FDA Grants Priority Review to AbbVie for Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Genotype 4 Chronic Hepatitis C 2U.S. FDA Grants Priority Review to AbbVie for Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Genotype 4 Chronic Hepatitis C 3U.S. FDA Grants Priority Review to AbbVie for Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Genotype 4 Chronic Hepatitis C 4U.S. FDA Grants Priority Review to AbbVie for Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Genotype 4 Chronic Hepatitis C 5U.S. FDA Grants Priority Review to AbbVie for Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Genotype 4 Chronic Hepatitis C 6U.S. FDA Grants Priority Review to AbbVie for Investigational, All-Oral, Interferon-Free Therapy for the Treatment of Genotype 4 Chronic Hepatitis C 7Information Update - New safety information for prescription-strength ibuprofen: Risk of heart attack and stroke at high doses 2Information Update - New safety information for prescription-strength ibuprofen: Risk of heart attack and stroke at high doses 3Information Update - New safety information for prescription-strength ibuprofen: Risk of heart attack and stroke at high doses 4Surna, Inc. Announces Shareholder Conference Call 2Surna, Inc. Announces Shareholder Conference Call 3
... July 9 The companies jointly announce the ... the Greek language version of the GeneMedRx drug and gene ... include hundreds of drugs used exclusively in Greece , ... user interface. Both the English and Greek versions of GeneMedRx ...
... HAMILTON , Canada , July ... to,reduce the incidence of venous thromboembolism in orthopedic surgery patients,in a ... McMaster University professor Dr. Alexander Turpie . , ... ...
Cached Medicine Technology:Medigene Appointed Exclusive Greek Licensee for GeneMedRx Personalized Prescribing Software 2Drug Study Shows Improvement in Major Orthopedic Surgery Care 2
Medtronic Ophthalmics offers a comprehensive selection of corneal trephine,blades and handles. Handcrafted, sharp, uniform blade edges promote a,symetrical and vertical cut of all corneal layers....
Each handle is designed to fit a specific trephine size....
Each handle is designed to fit a specific trephine size....
Each handle is designed to fit a specific trephine size....
Medicine Products: