|By PR Newswire||
|August 11, 2014 07:00 AM EDT||
LONDON, August 11, 2014 /PRNewswire/ --
Avillion LLP, a co-developer of late-stage pharmaceutical assets, announces that the first patients have been dosed in the United States in a global Phase 3 clinical trial called "BFORE," which is designed to assess the effectiveness and safety of BOSULIF® (bosutinib) as a first-line treatment for patients with chronic phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML). The first patient was dosed on July 22, 2014.
On January 9, 2014, Avillion announced it had entered into an exclusive collaborative development agreement with Pfizer Inc. to conduct a global Phase 3 clinical trial of BOSULIF®. Under the terms of the agreement, Avillion is providing the funding for and will conduct the trial to generate the clinical data necessary to potentially support a registration dossier for marketing authorization of BOSULIF® by regulatory authorities as first-line treatment of patients with chronic phase Ph+ CML. If approved for this indication, Avillion will be eligible to receive milestone payments from Pfizer upon regulatory approval of the drug. Pfizer will retain all rights to commercialize BOSULIF® globally.
Avillion intends to enrol approximately 530 patients into the BFORE (Bosutinib trial in First line chrOnic myelongenous leukemia tREatment) trial at multiple sites in the United States, Asia and Europe. The trial is a Phase 3, two-arm, randomized, open label trial. Patients will be randomized 1:1 to receive bosutinib or imatinib for the duration of the study (ClinicalTrials.gov Identifier: NCT02130557). The primary outcome is to show superiority of bosutinib over imatinib at 12 months by comparing the proportion of patients in each arm whose levels of the Bcr-Abl1 kinase, the target for bosutinib, have dropped below 0.1%.
Dr Jorge Cortes MD, Co-ordinating Investigator, based at MD Anderson Cancer Center (Houston, TX, USA), said: "The first patients dosed marks an important milestone on a study that we hope will confirm the results that we all expect, namely, a superior outcome with bosutinib compared to imatinib in this patient population. If the study results in such superiority, bosutinib could become a welcome new frontline treatment option for patients with CML for whom few treatment options currently exist."
BOSULIF® (bosutinib) is an oral, once-daily tyrosine kinase inhibitor (TKI), which inhibits the Bcr-Abl kinase that promotes CML; it is also an inhibitor of Src-family kinases. BOSULIF® is currently approved in the U.S. for the treatment of adult patients with Ph+ CML with resistance or intolerance to prior therapy and offers an important treatment option for these patients. In Europe, BOSULIF® was granted conditional marketing authorization for the treatment of adult patients with Ph+ CML previously treated with one or more TKIs and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.
Avillion LLP is a drug development company with an innovative business model focusing on the clinical development and regulatory approval of late stage pharmaceutical products. Avillion LLP offers a compelling opportunity to partner late-stage therapeutic projects for approval in the US and EU and to accelerate their availability to the market. Our objective is to enable our partners to continue to develop the drug candidates in their pipeline without increasing the burden on their P&L or cash reserves. Avillion LLP can achieve this by incurring 100% of the clinical and regulatory risk, while advancing the development of these late-stage assets.
Avillion was founded in 2012 in London, UK, and is backed by Abingworth, Clarus Ventures and Royalty Pharma. http://www.avillionllp.com
SOURCE Avillion LLP
We are reaching the end of the beginning with WebRTC, and real systems using this technology have begun to appear. One challenge that faces every WebRTC deployment (in some form or another) is identity management. For example, if you have an existing service – possibly built on a variety of different PaaS/SaaS offerings – and you want to add real-time communications you are faced with a challenge relating to user management, authentication, authorization, and validation. Service providers will w...
Dec. 27, 2014 02:00 PM EST Reads: 1,955
"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.
Dec. 27, 2014 01:30 PM EST Reads: 1,835
The term culture has had a polarizing effect among DevOps supporters. Some propose that culture change is critical for success with DevOps, but are remiss to define culture. Some talk about a DevOps culture but then reference activities that could lead to culture change and there are those that talk about culture change as a set of behaviors that need to be adopted by those in IT. There is no question that businesses successful in adopting a DevOps mindset have seen departmental culture change, ...
Dec. 27, 2014 12:45 PM EST Reads: 1,692
Explosive growth in connected devices. Enormous amounts of data for collection and analysis. Critical use of data for split-second decision making and actionable information. All three are factors in making the Internet of Things a reality. Yet, any one factor would have an IT organization pondering its infrastructure strategy. How should your organization enhance its IT framework to enable an Internet of Things implementation? In his session at Internet of @ThingsExpo, James Kirkland, Chief Ar...
Dec. 27, 2014 12:30 PM EST Reads: 2,443
WebRTC defines no default signaling protocol, causing fragmentation between WebRTC silos. SIP and XMPP provide possibilities, but come with considerable complexity and are not designed for use in a web environment. In his session at @ThingsExpo, Matthew Hodgson, technical co-founder of the Matrix.org, discussed how Matrix is a new non-profit Open Source Project that defines both a new HTTP-based standard for VoIP & IM signaling and provides reference implementations.
Dec. 27, 2014 12:30 PM EST Reads: 1,947
The 4th International DevOps Summit, co-located with16th International Cloud Expo – being held June 9-11, 2015, at the Javits Center in New York City, NY – announces that its Call for Papers is now open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the world's large...
Dec. 27, 2014 12:00 PM EST Reads: 2,692
DevOps Summit 2015 New York, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that it is now accepting Keynote Proposals. 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 development cycles that produce software that is obsolete...
Dec. 27, 2014 12:00 PM EST Reads: 1,784
The definition of IoT is not new, in fact it’s been around for over a decade. What has changed is the public's awareness that the technology we use on a daily basis has caught up on the vision of an always on, always connected world. If you look into the details of what comprises the IoT, you’ll see that it includes everything from cloud computing, Big Data analytics, “Things,” Web communication, applications, network, storage, etc. It is essentially including everything connected online from ha...
Dec. 27, 2014 12:00 PM EST Reads: 2,357
The security devil is always in the details of the attack: the ones you've endured, the ones you prepare yourself to fend off, and the ones that, you fear, will catch you completely unaware and defenseless. The Internet of Things (IoT) is nothing if not an endless proliferation of details. It's the vision of a world in which continuous Internet connectivity and addressability is embedded into a growing range of human artifacts, into the natural world, and even into our smartphones, appliances, a...
Dec. 27, 2014 11:30 AM EST Reads: 2,511
SAP is delivering break-through innovation combined with fantastic user experience powered by the market-leading in-memory technology, SAP HANA. In his General Session at 15th Cloud Expo, Thorsten Leiduck, VP ISVs & Digital Commerce, SAP, discussed how SAP and partners provide cloud and hybrid cloud solutions as well as real-time Big Data offerings that help companies of all sizes and industries run better. SAP launched an application challenge to award the most innovative SAP HANA and SAP HANA...
Dec. 27, 2014 11:00 AM EST Reads: 2,120
Connected devices and the Internet of Things are getting significant momentum in 2014. In his session at Internet of @ThingsExpo, Jim Hunter, Chief Scientist & Technology Evangelist at Greenwave Systems, examined three key elements that together will drive mass adoption of the IoT before the end of 2015. The first element is the recent advent of robust open source protocols (like AllJoyn and WebRTC) that facilitate M2M communication. The second is broad availability of flexible, cost-effective ...
Dec. 27, 2014 11:00 AM EST Reads: 1,993
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 ...
Dec. 27, 2014 11:00 AM EST Reads: 2,148
"SAP had made a big transition into the cloud as we believe it has significant value for our customers, drives innovation and is easy to consume. When you look at the SAP portfolio, SAP HANA is the underlying platform and it powers all of our platforms and all of our analytics," explained Thorsten Leiduck, VP ISVs & Digital Commerce at SAP, in this SYS-CON.tv interview at 15th Cloud Expo, held Nov 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 27, 2014 11:00 AM EST Reads: 1,935
The 3rd International Internet of @ThingsExpo, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that its Call for Papers is now open. The Internet of Things (IoT) is the biggest idea since the creation of the Worldwide Web more than 20 years ago.
Dec. 27, 2014 11:00 AM EST Reads: 7,176
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...
Dec. 27, 2014 10:00 AM EST Reads: 2,115