Fast Track Designation for Xilonix for Cachexia

XBiotech announced that the company has been granted Fast Track designation for its anti-cachexia drug, Xilonix. 

Xilonix was shown to stop or reverse cachexia in about a third of all advanced cancer patients treated in a clinical study. 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, vs. a median of 72 days in others.

XBiotech will now launch a pivotal Phase 3 study under the FDA’s Fast Track program to treat advanced colorectal cancer patients that are suffering from cachexia. The international study will be a randomized, controlled trial to evaluate overall survival in patients treated with Xilonix. The study’s results will be intended to provide the basis for marketing approval.

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.

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