FDA grants Fast Track designation to XBiotech’s Xilonix for treatment of cachexia

Published on October 4, 2012 at 2:44 AM · No Comments

XBiotech, a privately held biotechnology company, announced today that the company has been granted Fast Track designation for its anti-cachexia drug Xilonix.  The Company's groundbreaking therapeutic antibody was shown in a previous clinical study at MD Anderson Cancer Center in Texas to stop or reverse cachexia in about a third of all advanced cancer patients treated. Anti-tumor and anti-cachexia effects were seen in many different types of cancer. In patients with advanced colorectal cancer, the reversal of cachexia resulted in a dramatic improvement in life expectancy, with patients that responded to treatment having a median survival of 474 days, versus a median of 72 days in others.

Xilonix is a first-in-class True Human antibody that blocks an inflammatory substance (IL-1α) produced by the body in response to tumor growth. This so called sterile inflammatory response plays a role in cancer progression and the development of lethal symptoms such as cachexia.

XBiotech will now launch a pivotal Phase III study under the FDA's Fast Track program to treat advanced colorectal cancer patients that are suffering from cachexia.  The study will involve sites in the United States, Canada and Europe with the results intended to provide the basis for international marketing approval. The international study will be a randomized, controlled trial to evaluate overall survival in patients treated with Xilonix.

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