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
SYS-CON.TV
Cloud Expo & Virtualization 2009 East
PLATINUM SPONSORS:
IBM
Smarter Business Solutions Through Dynamic Infrastructure
IBM
Smarter Insights: How the CIO Becomes a Hero Again
Microsoft
Windows Azure
GOLD SPONSORS:
Appsense
Why VDI?
CA
Maximizing the Business Value of Virtualization in Enterprise and Cloud Computing Environments
ExactTarget
Messaging in the Cloud - Email, SMS and Voice
Freedom OSS
Stairway to the Cloud
Sun
Sun's Incubation Platform: Helping Startups Serve the Enterprise
POWER PANELS:
Cloud Computing & Enterprise IT: Cost & Operational Benefits
How and Why is a Flexible IT Infrastructure the Key To the Future?
Click For 2008 West
Event Webcasts
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.

Latest Cloud Developer Stories
The Internet of Things is a misnomer. That implies that everything is on the Internet, and that simply should not be - especially for things that are blurring the line between medical devices that stimulate like a pacemaker and quantified self-sensors like a pedometer or pulse tr...
"Ulunsoft is a start-up that focuses on how enterprises build cloud-based IT infrastructure for business," explained Haibo Zhu, President of Ulunsoft Corp, in this SYS-CON.tv interview at Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
"At our booth we are showing how to provide trust in the Internet of Things. Trust is where everything starts to become secure and trustworthy. Now with the scaling of the Internet of Things it becomes an interesting question – I've heard numbers from 200 billion devices next yea...
“DevOps is really about the business. The business is under pressure today, competitively in the marketplace to respond to the expectations of the customer. The business is driving IT and the problem is that IT isn't responding fast enough," explained Mark Levy, Senior Product M...
As enterprises engage with Big Data technologies to develop applications needed to meet operational demands, new computation fabrics are continually being introduced. To leverage these new innovations, organizations are sacrificing market opportunities to gain expertise in learni...
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