|By JCN Newswire||
|February 3, 2014 02:18 AM EST||
The SELECT (Study of (E7080) LEnvatinib in differentiated Cancer of the Thyroid) study was a multicenter, randomized, double-blind, placebo-controlled Phase III study to compare the PFS of patients with RR-DTC and radiographic evidence of disease progression within the prior 12 months, treated with once-daily, oral lenvatinib (24 mg) versus placebo. Secondary endpoints of the study included overall response rate (ORR), overall survival (OS) and safety. The study enrolled 392 patients at over 100 sites in Europe, North and South America and Asia and was conducted by Eisai in collaboration with the SFJ Pharmaceuticals Group. The preliminary safety analysis showed that the five most common adverse reactions were hypertension, diarrhea, decreased appetite, decreased weight and nausea.
Based on these clinical results, Eisai will submit marketing authorization applications for lenvatinib to health authorities in Japan, the United States and Europe. If approved, lenvatinib will be the first molecular-targeted small molecule agent developed by a Japanese pharmaceutical company.
Thyroid cancer is the most common endocrine malignancy and global figures show that its incidence has significantly increased over the last 50 years. RR-DTC, a life-threatening form of the disease, has a significant unmet treatment need. Lenvatinib, discovered and developed by Eisai, was granted Orphan Drug Designation (ODD) in Japan, the United States and Europe.
Eisai has also initiated a global Phase III trial of lenvatinib in hepatocellular carcinoma (HCC) and is conducting Phase II studies of lenvatinib in several other tumor types. Eisai is committed to understanding the potential clinical benefits of lenvatinib in order to further contribute to patients with cancer, including patients with thyroid cancer, and their families.
About Lenvatinib (E7080)
Lenvatinib, discovered and developed by Eisai, is an orally active, selective inhibitor of receptor tyrosine kinases (RTKs) with a novel binding mode, including KDR (VEGFR-2), Flt-1 (VEGFR-1), RET, FGFR1, PDGFR-Beta and c-kit, involved in angiogenesis and tumor proliferation. It is currently under development as a potential treatment for thyroid, hepatocellular (Phase III), endometrial (Phase II) and other solid tumor types. Lenvatinib was granted Orphan Drug Designation (ODD) in Japan for thyroid cancer in August 2012, in the United States for follicular, medullary, anaplastic, and metastatic or locally advanced papillary thyroid cancer in December 2012, and in Europe for follicular and papillary thyroid cancer in April 2013.
About Thyroid Cancer
Thyroid cancer refers to cancer that forms in the tissues of the thyroid gland, located at the base of the throat near the trachea. It is more common in women than in men and usually occurs between the ages of 25 and 65. The most common types of thyroid cancer, papillary and follicular (including Hurthle cell), are classified as differentiated thyroid cancer and account for approximately 95% of all cases. The remaining cases are classified as either undifferentiated (3-5% of cases) and medullary carcinoma (1-2% of cases). While most differentiated thyroid cancer patients are curable with surgery and radioactive iodine treatment, a small percentage of patients do not respond to therapy. There are limited treatment options for this difficult-to-treat, life-threatening and treatment-refractory form of thyroid cancer.
The SFJ Pharmaceuticals Group, which includes SFJ Pharma Ltd., is a Global Drug Development Company, which provides a unique co-development partnering model for some of the world's top Pharmaceutical and Biotechnology companies. SFJ uses its financial strength and core team of pharmaceutical development experts to provide highly customized partnering models in which SFJ provides the funding and clinical development supervision, necessary to obtain regulatory approval for some of the most promising drug development programs of Pharmaceutical and Biotechnology companies.
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, as well as develop small molecules, biologics, chemotherapies and supportive care agents for cancer across multiple indications.
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.
Public Relations Department, Eisai Co., Ltd. +81-3-3817-5120
Copyright 2014 JCN Newswire. All rights reserved. www.japancorp.net
Culture is the most important ingredient of DevOps. The challenge for most organizations is defining and communicating a vision of beneficial DevOps culture for their organizations, and then facilitating the changes needed to achieve that. Often this comes down to an ability to provide true leadership. As a CIO, are your direct reports IT managers or are they IT leaders? The hard truth is that many IT managers have risen through the ranks based on their technical skills, not their leadership ab...
Dec. 2, 2015 02:00 AM EST Reads: 444
The revocation of Safe Harbor has radically affected data sovereignty strategy in the cloud. In his session at 17th Cloud Expo, Jeff Miller, Product Management at Cavirin Systems, discussed how to assess these changes across your own cloud strategy, and how you can mitigate risks previously covered under the agreement.
Dec. 2, 2015 12:00 AM EST Reads: 141
In his General Session at DevOps Summit, Asaf Yigal, Co-Founder & VP of Product at Logz.io, explored the value of Kibana 4 for log analysis and provided a hands-on tutorial on how to set up Kibana 4 and get the most out of Apache log files. He examined three use cases: IT operations, business intelligence, and security and compliance. Asaf Yigal is co-founder and VP of Product at log analytics software company Logz.io. In the past, he was co-founder of social-trading platform Currensee, which...
Dec. 1, 2015 11:00 PM EST Reads: 307
SYS-CON Events announced today that Catchpoint, a global leader in monitoring, and testing the performance of online applications, has been named "Silver Sponsor" of DevOps Summit New York, which will take place on June 7-9, 2016 at the Javits Center in New York City. Catchpoint radically transforms the way businesses manage, monitor, and test the performance of online applications. Truly understand and improve user experience with clear visibility into complex, distributed online systems.Founde...
Dec. 1, 2015 10:15 PM EST Reads: 141
Today air travel is a minefield of delays, hassles and customer disappointment. Airlines struggle to revitalize the experience. GE and M2Mi will demonstrate practical examples of how IoT solutions are helping airlines bring back personalization, reduce trip time and improve reliability. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Dr. Sarah Cooper, M2Mi’s VP Business Development and Engineering, explored the IoT cloud-based platform technologies driving t...
Dec. 1, 2015 10:00 PM EST Reads: 477
"eFolder does a lot of different things but we protect data and we are focused on protecting data no matter where it resides," explained Carlo Tapia, Product Marketing Manager at eFolder, in this SYS-CON.tv interview at Cloud Expo, held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 1, 2015 04:00 PM EST
The Internet of Things (IoT) is growing rapidly by extending current technologies, products and networks. By 2020, Cisco estimates there will be 50 billion connected devices. Gartner has forecast revenues of over $300 billion, just to IoT suppliers. Now is the time to figure out how you’ll make money – not just create innovative products. With hundreds of new products and companies jumping into the IoT fray every month, there’s no shortage of innovation. Despite this, McKinsey/VisionMobile data...
Dec. 1, 2015 04:00 PM EST Reads: 507
Cloud computing is unquestionably one of the driving forces of DevOps, as the automation of operations transforms enterprise software development. DevOps, however, is more than a technology trend, as it represents a move toward silo-busting, self-organizing horizontal teams that drive business velocity. At the same time, enterprise Digital Transformation represents an upheaval across the enterprise, as customer preferences and behavior drive enterprise technology decisions. This transformation ...
Dec. 1, 2015 03:45 PM EST
Most of the IoT Gateway scenarios involve collecting data from machines/processing and pushing data upstream to cloud for further analytics. The gateway hardware varies from Raspberry Pi to Industrial PCs. The document states the process of allowing deploying polyglot data pipelining software with the clear notion of supporting immutability. In his session at @ThingsExpo, Shashank Jain, a development architect for SAP Labs, discussed the objective, which is to automate the IoT deployment proces...
Dec. 1, 2015 03:00 PM EST Reads: 154
Just over a week ago I received a long and loud sustained applause for a presentation I delivered at this year’s Cloud Expo in Santa Clara. I was extremely pleased with the turnout and had some very good conversations with many of the attendees. Over the next few days I had many more meaningful conversations and was not only happy with the results but also learned a few new things. Here is everything I learned in those three days distilled into three short points.
Dec. 1, 2015 03:00 PM EST Reads: 390
In demand-intensive mobile and web applications, an emerging pattern is to host the Systems of Engagement in the cloud (for maximum responsiveness) but keep the Systems of Record with the other important business systems in the company datacenter, often on a tightly secured mainframe. But what about the space in between? In this IBM Redpaper publication, we show that the IBM Bluemix cloud platform offers technologies that make it easy for cloud-based SoEs to securely connect to on-premises IBM...
Dec. 1, 2015 02:45 PM EST
DevOps is about increasing efficiency, but nothing is more inefficient than building the same application twice. However, this is a routine occurrence with enterprise applications that need both a rich desktop web interface and strong mobile support. With recent technological advances from Isomorphic Software and others, rich desktop and tuned mobile experiences can now be created with a single codebase – without compromising functionality, performance or usability. In his session at DevOps Su...
Dec. 1, 2015 02:45 PM EST Reads: 450
As organizations realize the scope of the Internet of Things, gaining key insights from Big Data, through the use of advanced analytics, becomes crucial. However, IoT also creates the need for petabyte scale storage of data from millions of devices. A new type of Storage is required which seamlessly integrates robust data analytics with massive scale. These storage systems will act as “smart systems” provide in-place analytics that speed discovery and enable businesses to quickly derive meaningf...
Dec. 1, 2015 02:15 PM EST Reads: 455
In his keynote at @ThingsExpo, Chris Matthieu, Director of IoT Engineering at Citrix and co-founder and CTO of Octoblu, focused on building an IoT platform and company. He provided a behind-the-scenes look at Octoblu’s platform, business, and pivots along the way (including the Citrix acquisition of Octoblu).
Dec. 1, 2015 02:00 PM EST Reads: 553
In his General Session at 17th Cloud Expo, Bruce Swann, Senior Product Marketing Manager for Adobe Campaign, explored the key ingredients of cross-channel marketing in a digital world. Learn how the Adobe Marketing Cloud can help marketers embrace opportunities for personalized, relevant and real-time customer engagement across offline (direct mail, point of sale, call center) and digital (email, website, SMS, mobile apps, social networks, connected objects).
Dec. 1, 2015 01:45 PM EST Reads: 359