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


Morphotek Announces Top-Line Results of a Phase III Study of Farletuzumab in Patients With Relapsed Platinum-Sensitive Epithelial Ovarian Cancer

EXTON, Pa., Jan. 10, 2013 /PRNewswire/ -- Morphotek® Inc., a wholly-owned subsidiary of Eisai Inc., announced today top-line results from a Phase III study of its investigational agent farletuzumab (MORAb-003) in combination with carboplatin and a taxane in patients with platinum-sensitive epithelial ovarian cancer in first relapse.

The study found that farletuzumab in combination with carboplatin and a taxane did not meet the study's primary endpoint of progression-free survival (PFS). 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 relevant health authorities.

In the double-blind, placebo-controlled study, 1,100 patients were enrolled to receive standard-of-care (carboplatin and a taxane [paclitaxel or docetaxel]) chemotherapy and were randomized to three parallel groups to receive one of two different dose levels of farletuzumab or placebo. 

"While we are disappointed with these results, we know that ovarian cancer is a difficult disease to treat successfully," says Dr. Nicholas Nicolaides, President and CEO of Morphotek. "Morphotek remains committed to research to understand the potential role of farletuzumab in ovarian and other types of cancer."

FAR 131 Study Design
The Phase III trial, also known as FAR 131, was a randomized, multicenter, double-blind, placebo-controlled study assessing the efficacy and safety of a weekly dose of farletuzumab in combination with standard-of-care (SOC) (carboplatin  and a taxane [paclitaxel or docetaxel]) chemotherapy as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) in patients with platinum-sensitive ovarian cancer in first relapse. In the study, 1,100 patients at 274 medical centers participated globally.

Patients received SOC and were randomized to three parallel groups to receive either 1.25 mg/kg of farletuzumab, 2.5 mg/kg of farletuzumab, or placebo. Patients received SOC every three weeks, and weekly farletuzumab or placebo for approximately six cycles. After approximately six cycles, patients received maintenance of placebo, 1.25 mg/kg or 2.5 mg/kg of farletuzumab until progression.

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 relapsed between six and 24 months from the time of completion of first-line platinum/taxane therapy. They also had to be eligible for carboplatin/taxane treatment.

About Farletuzumab
Farletuzumab is a humanized, IgG1 monoclonal antibody (mAb) 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 laboratory-generated 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.

About Ovarian Cancer
In the US, an estimated 22,280 new cases of ovarian cancer will have been diagnosed in 2012, causing 15,500 deaths. Most patients with ovarian cancer (approximately 90 percent) have epithelial (carcinomas) and are often diagnosed with advanced-stage disease. Although clinical complete remissions are obtained in the majority of patients through a combination of cytoreductive surgery and chemotherapy, relapse is common.

About Morphotek
Morphotek specializes in the development of protein and antibody products through the use of a novel and proprietary gene evolution technology. In the spring of 2007, Morphotek was acquired by Eisai Inc., a global health care pharmaceutical company. Morphotek's proprietary technologies and promising antibodies, combined with Eisai's existing research programs and infrastructure, enables the companies to work toward addressing unmet medical needs of patients, especially those with cancer and inflammatory diseases, all around the world. For more information, please visit www.morphotek.com

About Eisai Inc.
Eisai Inc. was established in 1995 and began marketing its first product in the United States in 1997. Since that time, Eisai Inc. has rapidly grown to become a fully integrated pharmaceutical business. Eisai's key areas of commercial focus are neurology and oncology. The company serves as the U.S. pharmaceutical operation of Eisai Co., Ltd., a research-based human health care (hhc) company that discovers, develops and markets products throughout the world. 

Eisai has a global product creation organization that includes U.S.-based R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as manufacturing facilities in Maryland and North Carolina. The company's areas of R&D focus include neuroscience; oncology; vascular, inflammatory and immunological reaction; and antibody-based programs. For more information about Eisai, please visit www.eisai.com/US.

Media Inquiries

Laurie Ostroff-Landau

Eisai Inc.

201-746-2510

               

           

Investor Inquiries

Alex Scott

Eisai Inc.

201-746-2177

 

SOURCE Morphotek Inc.

About PR Newswire
Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire 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 . . .
Dell and Red Hat Inc. have announced the availability of co-engineered, enterprise-grade, private cloud solutions based on OpenStack, the Dell Red Hat Cloud Solution, powered by Red Hat Enterprise Linux OpenStack Platform. The companies also have extended their collaboration to enable...
Last week was a crazy week for information security. That's probably also the understatement of the year. With the public exposure of Heartbleed, everyone was talking about what to do and how to do it to help customers and the Internet, in general, deal with the ramifications of such a...
Jelastic on Tuesday announced support for multiple ISV software packages in Jelastic’s products for enterprises, hosting service providers and developers. This support is achieved using OpenShift by Red Hat’s pluggable Cartridge standard, allowing those developers to build application ...
Red Hat on Monday announced OpenShift Marketplace, a one-stop shop that will enable customers to find and try solutions for their cloud applications. The OpenShift Marketplace will bring the power of Red Hat's OpenShift Platform-as-a-Service (PaaS) partner ecosystem directly to OpenShi...
ActiveState on Monday announced that Bernard Golden has joined the company as Vice President of Strategy. Named in Wired.com as one of the ten most influential people in cloud computing, Bernard has extensive experience working with organizations to help them adopt and integrate cloud ...
IBM has identified mobile devices, cloud computing and four other trends that are looking to shape the federal information technology of the future, according to Jane Snowdon, director and chief innovation officer at IBM Federal. In an op-ed for Federal Times, Snowdon writes that mbil...
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