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 atherosclerosis. Blocking chronic inflammation offers the potential to halt or even reverse the progression of atherosclerosis, 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."
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.
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-1α, 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.