Comments
yourfanat wrote: I am using another tool for Oracle developers - dbForge Studio for Oracle. This IDE has lots of usefull features, among them: oracle designer, code competion and formatter, query builder, debugger, profiler, erxport/import, reports and many others. The latest version supports Oracle 12C. More information here.
Cloud Expo on Google News

2008 West
DIAMOND SPONSOR:
Data Direct
SOA, WOA and Cloud Computing: The New Frontier for Data Services
PLATINUM SPONSORS:
Red Hat
The Opening of Virtualization
GOLD SPONSORS:
Appsense
User Environment Management – The Third Layer of the Desktop
Cordys
Cloud Computing for Business Agility
EMC
CMIS: A Multi-Vendor Proposal for a Service-Based Content Management Interoperability Standard
Freedom OSS
Practical SOA” Max Yankelevich
Intel
Architecting an Enterprise Service Router (ESR) – A Cost-Effective Way to Scale SOA Across the Enterprise
Sensedia
Return on Assests: Bringing Visibility to your SOA Strategy
Symantec
Managing Hybrid Endpoint Environments
VMWare
Game-Changing Technology for Enterprise Clouds and Applications
Click For 2008 West
Event Webcasts

2008 West
PLATINUM SPONSORS:
Appcelerator
Get ‘Rich’ Quick: Rapid Prototyping for RIA with ZERO Server Code
Keynote Systems
Designing for and Managing Performance in the New Frontier of Rich Internet Applications
GOLD SPONSORS:
ICEsoft
How Can AJAX Improve Homeland Security?
Isomorphic
Beyond Widgets: What a RIA Platform Should Offer
Oracle
REAs: Rich Enterprise Applications
Click For 2008 Event Webcasts
SYS-CON.TV
Top Links You Must Click On


Eisai Announces Results of Phase III Study of Anticancer Agent Farletuzumab in Patients with Relapsed Platinum-Sensitive Ovarian Cancer

Tokyo, Jan 11, 2013 - (JCN Newswire) - Eisai Co., Ltd. announced today the preliminary results of its global Phase III study (Study FAR 131, MORAb-003-004) of farletuzumab (MORAb-003), an investigational compound under development at its U.S. subsidiary, Morphotek, Inc., in patients with platinum-sensitive epithelial ovarian cancer in first relapse.

The study was a multicenter, randomized, double-blind, placebo-controlled, parallel-group comparative study of 1,100 patients with platinum-sensitive epithelial ovarian cancer in first relapse. The patients received standard-of-care therapy (carboplatin and a taxane) in combination with doses of either 1.25 mg/kg of farletuzumab, 2.5 mg/kg of farletuzumab, or placebo.

Preliminary results showed that the trial did not meet the pre-specified statistical criteria for significant progression-free survival (PFS), the study's primary endpoint. The post hoc exploratory analysis showed, however, a trend toward improved PFS in some patient subsets and further analysis is ongoing. The preliminary safety analysis indicated that the most commonly reported adverse events were those known to be associated with the study chemotherapy agents. Additionally, some immune-mediated events were observed with farletuzumab. After further analysis of these clinical results, the company will determine a new development strategy based on discussion with external experts and the relevant health authorities.

Eisai remains committed to understanding the potential clinical benefits of farletuzumab in order to further contribute to patients with cancer, including patients with recurrent ovarian cancer, and their families.

About farletuzumab

Farletuzumab is a humanized, IgG1 monoclonal antibody that binds to the folate receptor-alpha (FRA), a folate-binding protein that is expressed on ovarian and several other epithelial cancer cells. Monoclonal antibodies are a type of immunotherapy used to treat cancer that are manmade versions of immune system proteins and can be designed to attack a specific part of a cancer cell. Immunotherapy drugs offer a method of treatment separate from chemotherapy.

Study FAR 131 Design Summary

This Phase III trial was a multicenter, randomized, double-blind, placebo-controlled, parallel-group comparative study of 1,100 patients with platinum-sensitive epithelial ovarian cancer in first relapse enrolled in 274 medical centers. The study assessed the efficacy and safety of farletuzumab in combination with standard-of-care carboplatin and taxane (either a paclitaxel or docetaxel) chemotherapy. The primary endpoint was progression-free survival (PFS) as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Patients were randomized into three parallel groups to receive either a 1.25 mg/kg of farletuzumab, 2.5 mg/kg of farletuzumab or placebo, with all patients receiving standard-of-care therapy every three weeks and farletuzumab or placebo weekly for six cycles. After these six cycles, patients continued to receive their maintenance of placebo or farletuzumab until disease progression was observed.

Eligible patients must have been treated initially with surgery, had a response to first-line platinum- and taxane-based therapy, and have relapsed as defined by the presence of measurable disease. Patients must have also relapsed between 6 and 24 months from the time of completion of their first-line platinum and taxane therapy and been eligible for carboplatin and taxane treatment.

About Ovarian Cancer

Globally, an estimated 225,000 patients are diagnosed with ovarian cancer each year, with an estimated 140,000 deaths due to this disease annually. Approximately 90% of ovarian cancer tumors are epithelial (carcinomas) and often not diagnosed until the advanced stages of the disease. Although clinical complete remissions are obtained in the majority of patients through a combination of cytoreductive surgery and chemotherapy, relapse remains common.

Eisai's Commitment to Oncology

Eisai's commitment to meaningful progress in oncology research, built on scientific expertise, is supported by a global capability to conduct discovery and preclinical research, and develop small molecules, biologics, chemotherapies and supportive care agents for cancer across multiple indications. Along with its continued endeavors in obtaining further indication expansion for Halaven(R), Eisai plans to enhance its portfolio of products in the field of oncology with other agents such as its monoclonal antibody farletuzumab and lenvatinib, a VEGF (vascular endothelial growth factor) receptor tyrosine kinase inhibitor and multikinase inhibitor.

About Eisai

Eisai Co., Ltd. (TSE: 4523; ADR: ESALY) is a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. Eisai focuses its efforts in three therapeutic areas: integrative neuroscience, including neurology and psychiatric medicines; integrative oncology, which encompasses oncotherapy and supportive-care treatments; and vascular/immunological reaction. Through a global network of research facilities, manufacturing sites and marketing subsidiaries, Eisai actively participates in all aspects of the worldwide healthcare system. For more information about Eisai Co., Ltd., please visit www.eisai.com.



Source: Eisai

Contact:

Eisai Co., Ltd.,
Public Relations Department.
+81-3-3817-5120 


Copyright 2013 JCN Newswire. All rights reserved. www.japancorp.net
About JCN Newswire
Copyright 2008 JCN Newswire. All rights reserved. Republication or redistribution of JCN Newswire content is expressly prohibited without the prior written consent of JCN Newswire. JCN Newswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Enterprise Open Source Magazine Latest Stories . . .
The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long development cycles that produce software that is ob...
The recent trends like cloud computing, social, mobile and Internet of Things are forcing enterprises to modernize in order to compete in the competitive globalized markets. However, enterprises are approaching newer technologies with a more silo-ed way, gaining only sub optimal benefi...
WaveMaker on Tuesday announced WaveMaker Enterprise, licensed software that enables organizations to run their own end-to-end application platform as a service (aPaaS) for building and running custom apps. WaveMaker Enterprise is a commercially available rapid API app development and d...
The impact of DevOps in the cloud era is potentially profound. DevOps helps businesses deliver new features continuously, reduce cycle time and achieve sustained innovation by applying agile and lean principles to assist all stakeholders in an organization that develop, operate, or ben...
The industry is heated with debates on whether adopting private or public cloud is the smartest, best, cheapest, you name it choice. But this debate is missing the mark. Businesses shouldn’t be discussing public vs. private, but rather how can they make the two work together to their g...
After the transaction closes, Eucalyptus Chief Executive Officer (CEO) Marten Mickos, a respected leader in the cloud industry and a longtime advocate of open source, will join HP as senior vice president and general manager of the Cloud business, reporting to Meg Whitman, chairman, pr...
Subscribe to the World's Most Powerful Newsletters
Subscribe to Our Rss Feeds & Get Your SYS-CON News Live!
Click to Add our RSS Feeds to the Service of Your Choice:
Google Reader or Homepage Add to My Yahoo! Subscribe with Bloglines Subscribe in NewsGator Online
myFeedster Add to My AOL Subscribe in Rojo Add 'Hugg' to Newsburst from CNET News.com Kinja Digest View Additional SYS-CON Feeds
Publish Your Article! Please send it to editorial(at)sys-con.com!

Advertise on this site! Contact advertising(at)sys-con.com! 201 802-3021




SYS-CON Featured Whitepapers
ADS BY GOOGLE