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.

2008 West
DIAMOND SPONSOR:
Data Direct
SOA, WOA and Cloud Computing: The New Frontier for Data Services
PLATINUM SPONSORS:
Red Hat
The Opening of Virtualization
GOLD SPONSORS:
Appsense
User Environment Management – The Third Layer of the Desktop
Cordys
Cloud Computing for Business Agility
EMC
CMIS: A Multi-Vendor Proposal for a Service-Based Content Management Interoperability Standard
Freedom OSS
Practical SOA” Max Yankelevich
Intel
Architecting an Enterprise Service Router (ESR) – A Cost-Effective Way to Scale SOA Across the Enterprise
Sensedia
Return on Assests: Bringing Visibility to your SOA Strategy
Symantec
Managing Hybrid Endpoint Environments
VMWare
Game-Changing Technology for Enterprise Clouds and Applications
Click For 2008 West
Event Webcasts

2008 West
PLATINUM SPONSORS:
Appcelerator
Get ‘Rich’ Quick: Rapid Prototyping for RIA with ZERO Server Code
Keynote Systems
Designing for and Managing Performance in the New Frontier of Rich Internet Applications
GOLD SPONSORS:
ICEsoft
How Can AJAX Improve Homeland Security?
Isomorphic
Beyond Widgets: What a RIA Platform Should Offer
Oracle
REAs: Rich Enterprise Applications
Click For 2008 Event Webcasts
SYS-CON.TV
Today's Top SOA Links


XBiotech Receives Fast Track Designation from FDA for True Human™ Monoclonal Antibody Therapy Targeting Inflammatory Cytokine IL-1a for Restenosis
First Therapy for Treatment of Restenosis and Vascular Disease

AUSTIN, Texas, Jan. 3, 2013 /PRNewswire/ -- XBiotech, a privately held biotechnology company, announced today that the company has been granted Fast Track designation by the FDA for its therapeutic monoclonal antibody MABp1 (CV-18C3) as a treatment to reduce the need for re-intervention after superficial femoral artery (SFA) revascularization. Strong positive results from a recent Phase II study demonstrated that treatment with MABp1 resulted in prolonged patency of the SFA and reduction in Major Adverse Cardiovascular Events (MACE), indicating both a local treatment effect, as well as impact on underlying vascular disease.  

(Logo: http://photos.prnewswire.com/prnh/20121017/MM95359LOGO)

This is the second FDA Fast Track Designation secured by XBiotech for lead candidate MABp1. The first FDA Fast Track Designation was received by the Company at the end of last year for Xilonix™ (MABp1) therapy for the treatment of advanced cancer with associated cachexia. 

According to the American Heart Association, heart disease, stroke, and related vascular deaths are by far the leading causes of disease and death in the United States.1 The economic impact from heart disease and stroke in the United States for 2007 (including health expenditures and lost productivity) was $286 billion – higher than any other disease.2 Chronic inflammation in the blood vessel wall results in progression of arterial disease such as atherosclerois. Blocking chronic inflammations offers the potential to halt or even reverse the progression of atherosclerois, as well as reduce the impact of heart attack and stroke. 

"We appreciate the FDA's review of our clinical results and their support for moving this program forward as quickly as possible for patients," said Michael Stecher, M.D., Medical Director of XBiotech.  "Blocking chronic inflammation with a therapeutic antibody has the potential to provide an important treatment option for endovascular surgeons and interventional cardiologists who currently have limited or no options for addressing restenosis or the underlying complications of vascular disease in these patients. We believe MABp1 represents a significant advance in the field, offering new hope to both patients and physicians."

"We are very pleased to receive a second Fast Track Designation from the FDA for our lead compound targeting the inflammatory cytokine IL-1a," said John Simard, president and CEO, of XBiotech. "Using an anti-IL-1a True Human antibody to inhibit vascular inflammation appears to be broadly beneficial to cardiovascular health and could have significant implications in helping to reduce the high costs of healthcare associated not only with restenosis, but overall complications of vascular disease. With the advance of multiple regulatory paths, we are indeed closer to establishing a new medical paradigm - that multiple diseases can be treated through blocking chronic inflammatory processes.

About True Human™ Antibodies
True Human™ antibodies represent the next generation of therapeutic antibodies.  These antibodies are identified using the Company's proprietary platform technology to ensure faithful reproduction of the original human antibody gene.  True Human antibodies are "invisible" to the body's immune system and thus have the potential for better safety, efficacy and patient tolerability compared to earlier generation antibody therapeutics.

About XBiotech
XBiotech is pioneering breakthrough therapies that improve the safety and efficacy of antibody therapeutics. The Company's lead product candidate inhibits chronic sterile inflammation by targeting IL-1a, a master regulator of inflammation. The clinical development program addresses tremendous unmet medical need in multiple disease indications including, acne, psoriasis, cachexia, cancer, type 2 diabetes and cardiovascular disease. XBiotech is also revolutionizing scalable, flexible manufacturing systems for the production of biological therapies.  Using minimal infrastructure and disposable bioreactor technology – to dramatically reduce capital requirements, operating complexity, and lead times - the Company has established a compelling commercialization path for its True Human™ antibody platform.  For more information on how XBiotech is advancing human monoclonal antibody therapy please visit www.xbiotech.com.

1 AHA Special Report 2010 - Defining and Setting National Goals for Cardiovascular Health Promotion and Disease Reduction

2 AHA December 14, 2010 - Heart disease, stroke deaths continue to fall but costs remain high

Contact: 
Investors: 
John Simard
XBiotech
info@xbiotech.com
512.386.2930                                                        

Media:
Aaron DeLucia
Porter Novelli
aaron.delucia@porternovelli.com
512.241.2249                                                        

SOURCE XBiotech

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.

Web 2.0 Latest News
When a CIO or a CTO thinks of the applications they support it is almost always in terms of a "portfolio" When a research company named Gleanster poll executives about agile data management they discovered an interesting trend. Companies are reporting an increase in portfolio sizes wi...
Hortonworks went through an IPO last Friday, December 12, 2014. It’s initial price of $16 soared by 60% immediately after. Today the stock price is $24.70 with a market cap of $1.02B. Another billion dollar club member. They compete with Cloudera and MapR in packaging the open source H...
You are a hobbyist; curious student or a developer-entrepreneur then you must get this kit to jump start your IoT development. This is still in Beta but it has everything you need in terms of hardware, software, tools and forums to guide you through. IoT dev kit is a subset of In...
We recently changed over the entire phone system in our London office. After four years, the equipment failed, and it was time to update. As we did so, we also changed vendors. Why? It occurred to us that, for four years, we had put up with horrible support – we were the victims of...
Our last post defined customer lifetime value (CLV) as the metric critical in measuring the success or failure of a recurring revenue program. In order for your company to routinely return significant revenue, maximizing CLV needs to be at the top of your priority list. A CLV-supported...
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