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In many cases, the end of the year gives you time to step back and take stock of the last 12 months. This is when many of us take a hard look at what worked and what did not, complete performance reviews, and formulate plans for the coming year. For me, it is all of those things plus a time when I u...
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.  


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

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

John Simard

Aaron DeLucia
Porter Novelli


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.

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