|By PR Newswire||
|January 8, 2014 01:15 AM EST||
OSAKA, Japan, Jan. 8, 2014 /PRNewswire/ -- Takeda Pharmaceutical Company Limited ("Takeda") announced today that vedolizumab (development code: MLN0002), an investigational drug for the treatment of moderate and severe ulcerative colitis (UC) and Crohn's disease (CD), has entered into two new phase 3 clinical trials in Japan.
The clinical trials are both placebo-controlled, multicenter, randomized, double-blind, parallel-group studies designed to evaluate the efficacy, safety and pharmacokinetics of vedolizumab as an induction and maintenance therapy for ulcerative colitis and Crohn's disease. Primary endpoints include clinical response at the 10th week (induction phase), and clinical remission after 60 weeks (maintenance phase).
"Many patients suffering from ulcerative colitis and Crohn's disease are eagerly awaiting new treatment options," said Asit Parikh, M.D., Ph.D., vice president, general medicine, Takeda. "We are striving to accelerate the development of this drug to deliver this effective and highly anticipated treatment option for patients in Japan as soon as possible."
Takeda has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) in March 2013, as well as a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in June 2013, seeking approval for vedolizumab for the treatment of adults with moderately to severely active ulcerative colitis or Crohn's disease.
About ulcerative colitis and Crohn's disease
Ulcerative colitis (UC) and Crohn's disease (CD) are the two most common forms of inflammatory bowel disease (IBD), which is marked by inflammation in the GI tract. UC usually only affects the large intestine, which includes the colon and the rectum. The most common symptoms of UC include abdominal discomfort and blood or pus in diarrhea. CD can impact any part of the digestive tract and common symptoms may include abdominal pain, diarrhea, rectal bleeding, weight loss, and fever. There is no known cause for UC or CD, although many researchers believe that the interaction between genes, the body's immune system, and environmental factors may play a role. The aim of UC and CD treatments is to induce and maintain remission, or achieve extended periods of time when patients do not experience symptoms.
Vedolizumab, under development for the treatment of UC and CD, is a humanized monoclonal antibody that specifically antagonizes the alpha4beta7 integrin, inhibiting the binding of alpha4beta7 to intestinal mucosal addressin cell adhesion molecule 1 (MAdCAM-1). MAdCAM-1 is preferentially expressed on blood vessels and lymph nodes of the gastrointestinal tract. The alpha4beta7 integrin is expressed on a subset of circulating white blood cells. These cells have been shown to play a role in mediating the inflammatory process in UC and CD. By inhibiting alpha4beta7, vedolizumab limits the ability of these lymphocytes to infiltrate gut tissues.
SYS-CON Media announced that Splunk, a provider of the leading software platform for real-time Operational Intelligence, has launched an ad campaign on Big Data Journal. Splunk software and cloud services enable organizations to search, monitor, analyze and visualize machine-generated big data coming from websites, applications, servers, networks, sensors and mobile devices. The ads focus on delivering ROI - how improved uptime delivered $6M in annual ROI, improving customer operations by minin...
Jan. 29, 2015 02:15 AM EST Reads: 3,739
Code Halos - aka "digital fingerprints" - are the key organizing principle to understand a) how dumb things become smart and b) how to monetize this dynamic. In his session at @ThingsExpo, Robert Brown, AVP, Center for the Future of Work at Cognizant Technology Solutions, outlined research, analysis and recommendations from his recently published book on this phenomena on the way leading edge organizations like GE and Disney are unlocking the Internet of Things opportunity and what steps your o...
Jan. 29, 2015 02:00 AM EST Reads: 2,971
Scott Jenson leads a project called The Physical Web within the Chrome team at Google. Project members are working to take the scalability and openness of the web and use it to talk to the exponentially exploding range of smart devices. Nearly every company today working on the IoT comes up with the same basic solution: use my server and you'll be fine. But if we really believe there will be trillions of these devices, that just can't scale. We need a system that is open a scalable and by using ...
Jan. 29, 2015 02:00 AM EST Reads: 2,929
In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect at GE, and Ibrahim Gokcen, who leads GE's advanced IoT analytics, focused on the Internet of Things / Industrial Internet and how to make it operational for business end-users. Learn about the challenges posed by machine and sensor data and how to marry it with enterprise data. They also discussed the tips and tricks to provide the Industrial Internet as an end-user consumable service using Big Data Analytics and Industrial C...
Jan. 29, 2015 01:00 AM EST Reads: 2,830
How do APIs and IoT relate? The answer is not as simple as merely adding an API on top of a dumb device, but rather about understanding the architectural patterns for implementing an IoT fabric. There are typically two or three trends: Exposing the device to a management framework Exposing that management framework to a business centric logic Exposing that business layer and data to end users. This last trend is the IoT stack, which involves a new shift in the separation of what stuff happe...
Jan. 29, 2015 12:30 AM EST Reads: 2,967
"SOASTA built the concept of cloud testing in 2008. It's grown from rather meager beginnings to where now we are provisioning hundreds of thousands of servers on a daily basis on behalf of customers around the world to test their applications," explained Tom Lounibos, CEO of SOASTA, in this SYS-CON.tv interview at DevOps Summit, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Jan. 29, 2015 12:00 AM EST Reads: 2,527
"ElasticBox is an enterprise company that makes it very easy for developers and IT ops to collaborate to develop, build and deploy applications on any cloud - private, public or hybrid," stated Monish Sharma, VP of Customer Success at ElasticBox, in this SYS-CON.tv interview at DevOps Summit, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Jan. 28, 2015 11:00 PM EST Reads: 2,573
The Internet of Things (IoT) promises to evolve the way the world does business; however, understanding how to apply it to your company can be a mystery. Most people struggle with understanding the potential business uses or tend to get caught up in the technology, resulting in solutions that fail to meet even minimum business goals. In his session at @ThingsExpo, Jesse Shiah, CEO / President / Co-Founder of AgilePoint Inc., showed what is needed to leverage the IoT to transform your business. ...
Jan. 28, 2015 07:30 PM EST Reads: 3,248
IoT is still a vague buzzword for many people. In his session at @ThingsExpo, Mike Kavis, Vice President & Principal Cloud Architect at Cloud Technology Partners, discussed the business value of IoT that goes far beyond the general public's perception that IoT is all about wearables and home consumer services. He also discussed how IoT is perceived by investors and how venture capitalist access this space. Other topics discussed were barriers to success, what is new, what is old, and what th...
Jan. 28, 2015 06:15 PM EST Reads: 4,043
The Internet of Things (IoT) is rapidly in the process of breaking from its heretofore relatively obscure enterprise applications (such as plant floor control and supply chain management) and going mainstream into the consumer space. More and more creative folks are interconnecting everyday products such as household items, mobile devices, appliances and cars, and unleashing new and imaginative scenarios. We are seeing a lot of excitement around applications in home automation, personal fitness,...
Jan. 28, 2015 06:00 PM EST Reads: 2,963
Dale Kim is the Director of Industry Solutions at MapR. His background includes a variety of technical and management roles at information technology companies. While his experience includes work with relational databases, much of his career pertains to non-relational data in the areas of search, content management, and NoSQL, and includes senior roles in technical marketing, sales engineering, and support engineering. Dale holds an MBA from Santa Clara University, and a BA in Computer Science f...
Jan. 28, 2015 06:00 PM EST Reads: 3,213
“The year of the cloud – we have no idea when it's really happening but we think it's happening now. For those technology providers like Zentera that are helping enterprises move to the cloud - it's been fun to watch," noted Mike Loftus, VP Product Management and Marketing at Zentera Systems, in this SYS-CON.tv interview at Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Jan. 28, 2015 05:00 PM EST Reads: 2,141
The Industrial Internet revolution is now underway, enabled by connected machines and billions of devices that communicate and collaborate. The massive amounts of Big Data requiring real-time analysis is flooding legacy IT systems and giving way to cloud environments that can handle the unpredictable workloads. Yet many barriers remain until we can fully realize the opportunities and benefits from the convergence of machines and devices with Big Data and the cloud, including interoperability, ...
Jan. 28, 2015 04:00 PM EST Reads: 2,721
OneCloud Software has launched the OneCloud Partner Program. Responding to demand from prospective partners, the Program offers managed service providers (MSPs) and resellers the resources they need to grow their business with the OneCloud Recovery solution. OneCloud Recovery is an automated solution for disaster recovery/business continuity (DR/BC), which leverages Amazon Web Services as the disaster recovery site. “This is a tremendous opportunity with an innovative hybrid cloud-based DR pro...
Jan. 28, 2015 03:30 PM EST Reads: 894
Cloud Technology Partners on Wednesday announced it has been recognized by the Modern Infrastructure Impact Awards as one of the Best Amazon Web Services (AWS) Consulting Partners. Selected by the editors of TechTarget's SearchDataCenter.com, and by votes from customers and strategic channel partners, the companies acknowledged by the Modern Infrastructure Impact Awards represent the top providers of cloud consulting services for AWS including application migration, application development, inf...
Jan. 28, 2015 03:00 PM EST Reads: 1,442