Welcome!

News Feed Item

XBiotech Enrolls First Patient in Phase III European Registration Study Using Xilonix™ for Treatment of Colorectal Cancer

AUSTIN, Texas, Aug. 1, 2014 /PRNewswire/ -- XBiotech has enrolled the first patient into its European Phase III study using its novel cancer drug Xilonix™ for the treatment of colorectal cancer. The double-blinded placebo controlled study is evaluating the use of the monoclonal antibody therapy designed to block chronic inflammation associated with malignant tumor growth. The treatment is reportedly aimed at reversing disease symptoms associated with disease progression and survival. The Company says novel surrogate endpoints used in the study were established through close collaboration with the European Medicines Agency (EMA) scientific advice committee. XBiotech claims that compared with traditional oncology study endpoints, these will enable faster and more informative evaluation of anti-cancer therapy in patients with advance disease. The results of the study, if completed successfully, will reportedly allow for full marketing approval for Xilonix among member states of the European Union. 

The study, headed by acclaimed oncologist Dr. Tamas Hickish is being simultaneously launched in a number of western and eastern European states. Dr. Hickish remarked, "The enthusiasm of patients and doctors for this study is very encouraging for the success of this trial and indicates Xilonix indeed targets an un-met medical need." XBiotech is executing the study in collaboration with KCR, a contract research organization headed in Eastern Europe. Dr. Anna Baran, Chief Medical Officer at KCR, stated, "The oncology research community, including multiple investigators in this study, are looking forward to the scientific outcome of XBiotech's clinical trial," and added that "the novel approach targeting IL-1 pathway is extremely interesting for all stakeholders, not only in the advanced colorectal cancer population, but also in other advanced cancer settings."

The Company reports there are numerous patients awaiting enrollment. Gary Gonzales, XBiotech's Vice President of Clinical Operations stated, "It is exciting to enter the enrollment phase of the trial with what appears to be a strong momentum. We hope that this will continue as additional countries are activated."

Xilonix is a first-in-class True Human™ antibody. The therapy works to block a number of processes that tumors use to grow and spread, such as potentially inhibiting the formation of tumor blood supply and new metastasis. Blocking tumor-related inflammation may also inhibit or reverse wasting and other illness associated with the malignancy.

About XBiotech
XBiotech is leading the commercialization of biological therapies—including the discovery and development of True Human™ antibodies. XBiotech is developing therapeutics for the treatment of major unmet medical needs in oncology, dermatology, vascular and infectious diseases. The Company's most advanced clinical program is a breakthrough therapy for cancer. XBiotech has also established the manufacturing technology to reduce infrastructure needs, lessen capital requirements and shorten lead times for biological drugs, ushering in a new era for cost efficiency in the biopharmaceutical industry.

Contact: 
Ashley Otero
XBiotech
[email protected]
512.386.2930

SOURCE XBiotech

More Stories By 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 Stories
SYS-CON Events announced today that StarNet Communications will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. StarNet Communications’ FastX is the industry first cloud-based remote X Windows emulator. Using standard Web browsers (FireFox, Chrome, Safari, etc.) users from around the world gain highly secure access to applications and data hosted on Linux-based servers in a central data center. ...
Traditional on-premises data centers have long been the domain of modern data platforms like Apache Hadoop, meaning companies who build their business on public cloud were challenged to run Big Data processing and analytics at scale. But recent advancements in Hadoop performance, security, and most importantly cloud-native integrations, are giving organizations the ability to truly gain value from all their data. In his session at 19th Cloud Expo, David Tishgart, Director of Product Marketing ...
Data is the fuel that drives the machine learning algorithmic engines and ultimately provides the business value. In his session at Cloud Expo, Ed Featherston, a director and senior enterprise architect at Collaborative Consulting, will discuss the key considerations around quality, volume, timeliness, and pedigree that must be dealt with in order to properly fuel that engine.
There is growing need for data-driven applications and the need for digital platforms to build these apps. In his session at 19th Cloud Expo, Muddu Sudhakar, VP and GM of Security & IoT at Splunk, will cover different PaaS solutions and Big Data platforms that are available to build applications. In addition, AI and machine learning are creating new requirements that developers need in the building of next-gen apps. The next-generation digital platforms have some of the past platform needs a...
19th Cloud Expo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Meanwhile, 94% of enterpri...
SYS-CON Events announced today Telecom Reseller has been named “Media Sponsor” of SYS-CON's 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Telecom Reseller reports on Unified Communications, UCaaS, BPaaS for enterprise and SMBs. They report extensively on both customer premises based solutions such as IP-PBX as well as cloud based and hosted platforms.
The 19th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Digital Transformation, Microservices and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportuni...
As the world moves toward more DevOps and Microservices, application deployment to the cloud ought to become a lot simpler. The Microservices architecture, which is the basis of many new age distributed systems such as OpenStack, NetFlix and so on, is at the heart of Cloud Foundry - a complete developer-oriented Platform as a Service (PaaS) that is IaaS agnostic and supports vCloud, OpenStack and AWS. Serverless computing is revolutionizing computing. In his session at 19th Cloud Expo, Raghav...
Enterprises have forever faced challenges surrounding the sharing of their intellectual property. Emerging cloud adoption has made it more compelling for enterprises to digitize their content, making them available over a wide variety of devices across the Internet. In his session at 19th Cloud Expo, Santosh Ahuja, Director of Architecture at Impiger Technologies, will introduce various mechanisms provided by cloud service providers today to manage and share digital content in a secure manner....
StarNet Communications Corp has announced the addition of three Secure Remote Desktop modules to its flagship X-Win32 PC X server. The new modules enable X-Win32 to safely tunnel the remote desktops from Linux and Unix servers to the user’s PC over encrypted SSH. Traditionally, users of PC X servers deploy the XDMCP protocol to display remote desktop environments such as the Gnome and KDE desktops on Linux servers and the CDE environment on Solaris Unix machines. XDMCP is used primarily on comp...
Fact: storage performance problems have only gotten more complicated, as applications not only have become largely virtualized, but also have moved to cloud-based infrastructures. Storage performance in virtualized environments isn’t just about IOPS anymore. Instead, you need to guarantee performance for individual VMs, helping applications maintain performance as the number of VMs continues to go up in real time. In his session at Cloud Expo, Dhiraj Sehgal, Product and Marketing at Tintri, wil...
DevOps at Cloud Expo, taking place Nov 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 19th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. 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 dev...
SYS-CON Events announced today that Isomorphic Software will exhibit at DevOps Summit at 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Isomorphic Software provides the SmartClient HTML5/AJAX platform, the most advanced technology for building rich, cutting-edge enterprise web applications for desktop and mobile. SmartClient combines the productivity and performance of traditional desktop software with the simp...
With so much going on in this space you could be forgiven for thinking you were always working with yesterday’s technologies. So much change, so quickly. What do you do if you have to build a solution from the ground up that is expected to live in the field for at least 5-10 years? This is the challenge we faced when we looked to refresh our existing 10-year-old custom hardware stack to measure the fullness of trash cans and compactors.
Extreme Computing is the ability to leverage highly performant infrastructure and software to accelerate Big Data, machine learning, HPC, and Enterprise applications. High IOPS Storage, low-latency networks, in-memory databases, GPUs and other parallel accelerators are being used to achieve faster results and help businesses make better decisions. In his session at 18th Cloud Expo, Michael O'Neill, Strategic Business Development at NVIDIA, focused on some of the unique ways extreme computing is...