Navigation Links
Sopherion Therapeutics Announces Completion of Enrollment in Phase III Study of Myocet in Metastatic Breast Cancer
Date:3/18/2009

PRINCETON, N.J., March 18 /PRNewswire/ -- Sopherion Therapeutics, LLC, a biopharmaceutical company focused on the development and commercialization of anti-cancer therapies, announced that it completed enrollment in its pivotal Phase III study of nonpegylated liposomal doxorubicin (Myocet(TM)) in metastatic HER-2-overexpressing breast cancer. This is a pivotal Phase III trial of Sopherion's lead product in combination with the current standard of care, paclitaxel (Taxol) and trastuzumab (Herceptin(R)), vs. paclitaxel and trastuzumab alone. Progression-free survival (PFS) is the primary efficacy endpoint, with careful monitoring for cardiac safety.

Dr. Jose Baselga, Chairman & Professor of Medicine, Vall d'Hebron Institute of Oncology (V.H.I.O.), Vall d'Hebron University Hospital in Barcelona, Spain, and principal investigator for the trial, said, "I am pleased to see that the recruitment phase of the Phase III trial has now been completed. This registration trial is based on our recently published, Roche-supported study conducted by the Spanish Breast Cancer Cooperative Group (SOLTI). Results showed that Myocet, in combination with trastuzumab and paclitaxel treatment, yielded an unusually high clinical response rate and time to progression in patients with HER-2 overexpressing breast cancer; the 3 drug combination was well tolerated with no cases of treatment-related symptomatic congestive heart failure. "

Phase III Study Design

The study is a global, randomized, multicenter pivotal Phase III study in 363 patients who have metastatic HER-2-overexpressing breast cancer. Eligibility criteria included no prior chemotherapy for metastatic disease, nor any trastuzumab, anthracyclines or taxanes within the previous 12 months. Eligible patients were randomized to receive either Myocet, paclitaxel and trastuzumab, or paclitaxel and trastuzumab alone in a 1:1 randomiza
'/>"/>

SOURCE Sopherion Therapeutics, LLC
Copyright©2009 PR Newswire.
All rights reserved

Page: 1 2 3

Related biology technology :

1. Sopherion Therapeutics Secures $55 Million in Series C Funding
2. Sopherion Therapeutics, LLC Announces Publication of Phase I/II Myocet(R) (Nonpegylated Liposomal Doxorubicin) Data in Advanced Breast Cancer Patients
3. FDA Accepts IND for Arno Therapeutics Pan-DAC / Akt Inhibitor, AR-42
4. Sirion Therapeutics Supplemental New Drug Application for Durezol(TM) to Treat Uveitis is Accepted for Review by the FDA
5. United Therapeutics Announces Probable Delay in Approval Timeline for Inhaled Treprostinil (Tyvaso)
6. Cell Therapeutics, Inc. (CTI) Reports 2008 Fourth Quarter and Year End Financial Results
7. Cell Therapeutics, Inc. (CTI) to Present at 8th Annual WBBA Invest Northwest Conference
8. Michael J. Fox Foundation Commits Up To $5 Million for Pre-Clinical Drug Development Under Industry-Exclusive Therapeutics Development Initiative
9. CV Therapeutics Board of Directors Rejects Astellas Tender Offer
10. Cell Therapeutics, Inc. (CTI) to Report Fourth Quarter and Year-End Financial Results on March 16
11. Amicus Therapeutics to Present at the Cowen and Company 29th Annual Healthcare Conference on March 17, 2009
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/23/2014)... Boston, MA (PRWEB) July 23, 2014 ... regenerative medicine transplant therapies are biological, but not ... trials may seem to treat them as if ... as well as unsanctioned studies that constitute “stem ... transplantation as an approach to developing new regenerative ...
(Date:7/22/2014)... D.C., June 22, 2014 Even within a phylum so ... is distinguished among other arthropods for its cruelty -- at ... Central America, the fly is a most predatory sort of ... cricket, deposits a smear of larvae, and leaves its wicked ... out. , None of this would be possible without ...
(Date:7/22/2014)... , July 22, 2014   BioTE Medical ... using natural, bio-identical hormone pellets, today announced the ... to the company.   Dr. Rouzier is joining the ...     Dr. Rouzier was residency trained ... and is a board certified emergency physician still ...
(Date:7/22/2014)... Wisconsin (PRWEB) July 22, 2014 ... in attendance at the 2014 NCSL International Workshop ... Booth #423 will feature CONDEC pressure instrumentation, OIML ... weights, and the new, customized sets, Essential Weights™. ... to promote cooperative efforts in solving the common ...
Breaking Biology Technology:The Adult Stem Cell Technology Center, LLC Continues to Develop Technologies for Homologous Adult Stem Cell Therapies and Drug Development 2The Adult Stem Cell Technology Center, LLC Continues to Develop Technologies for Homologous Adult Stem Cell Therapies and Drug Development 3The Adult Stem Cell Technology Center, LLC Continues to Develop Technologies for Homologous Adult Stem Cell Therapies and Drug Development 4The Adult Stem Cell Technology Center, LLC Continues to Develop Technologies for Homologous Adult Stem Cell Therapies and Drug Development 5Fly-inspired sound detector 2Fly-inspired sound detector 3Fly-inspired sound detector 4Dr. Neal Rouzier Joins BioTE Medical 2Dr. Neal Rouzier Joins BioTE Medical 3Rice Lake Weighing Systems Showcases Metrology Solutions for the 2014 NCSL International Workshop & Symposium 2
... Bunge North America, the North American operating arm of Bunge ... which can be attributed to Soren Schroder, Bunge North America ... aware from press reports of Syngenta,s allegations.  From what we ... and disappointed that Syngenta has taken an action which could ...
... 23, 2011 MedNet Solutions, a global life sciences technology ... to announce that MedNet has once again been recognized by ... held companies in the United States.  MedNet is greatly honored ... straight year, since, as noted by Inc . magazine, ...
... FMC Corporation (NYSE: FMC ) announced today ... agreements covering global development and supply of Chr. Hansen ... begin commercialization this year of Chr. Hansen,s Nemix bacillus ... standalone and combination products in the Americas and key ...
Cached Biology Technology:Bunge Responds to Syngenta Suit 2MedNet Solutions Achieves the Inc. 5000 List Five Years in a Row 2FMC Corporation Announces Exclusive Global Development and Supply Agreements for Chr. Hansen Biological Products 2
(Date:7/22/2014)... research has shown squirrels have adapted to New York ... well, if not better, than their fellow squirrels in ... Curtin,s Department of Environment & Agriculture, led the study ... their behaviour in urban environments and prevent unnecessary responses ... staying on the footpath. , "As we rapidly ...
(Date:7/22/2014)... natural habitats and trees and not just asphalt and ... a University of Colorado Boulder study. , Working on ... stress-reducing benefits for youth, according to a paper published ... study is one of the first of its kind ... green settings and stress. , "Many schools already offer ...
(Date:7/22/2014)... -- Open a child,s lunch box and you,re likely to ... federal guidelines. Those are the findings of a study conducted ... Policy at Tufts University and in the Department of Public ... The findings are published online ahead of print in ... . , Led by senior author Jeanne Goldberg, Ph.D., ...
Breaking Biology News(10 mins):New York squirrels are nuts about city life 2Natural-terrain schoolyards reduce children's stress, says Colorado University-Boulder study 2Natural-terrain schoolyards reduce children's stress, says Colorado University-Boulder study 3Room for improvement in elementary school children's lunches and snacks from home 2
... , June 19, 2013  Paris Air Show – ... Systems) , a leading provider of innovative test solutions ... solutions this week at the Paris Air Show ... complex armament systems with longer lifecycles, industry leaders are ...
... University, sophisticated computational models and advances in graphical processing ... genomic data, virus structure and the formation of the ... "We hope that some of what we are ... unable to replicate," says post-doctoral fellow Jason Perlmutter, first ...
... Washington, D.C. June 18, 2013 Joshua Obar, ... UniversityBozeman, has been honored with a 2013 ICAAC Young ... the regulation of immunological memory responses to infection. ... Wesleyan University in 2001 and went on to complete ...
Cached Biology News:Marvin Test Solutions Demonstrates Next-Generation Armament Test Solutions at Paris Air Show 2Marvin Test Solutions Demonstrates Next-Generation Armament Test Solutions at Paris Air Show 3Computer modeling technique goes viral at Brandeis 2The American Society for Microbiology honors Joshua Obar 2
... 1 ( Abpromise for all tested applications). ... to KLH derived from within residues 1850 to ... (Note: the amino acid sequence is proprietary) ... Entrez Gene ID: 89796 ...
Na+/H+ exchanger, isoform NHE1....
Anti-Potassium Channel EAG-1 Immunogen: Synthetic peptide from the C-terminus of rat Kv10.1 (Accession Q63472). The immunogen sequence is identical in mouse and 14/16 residues identical in human...
Mouse monoclonal [DAPK-55] to DAP Kinase 1 ( Abpromise for all tested applications). entrezGeneID: 1612 SwissProtID: P53355...
Biology Products: