XBiotech announced today enrollment of the first patient into its Phase III trial of Xilonix. The Pivotal study is designed to improve health and survival of late stage colorectal cancer patients with associated cachexia. The patient was enrolled by Dr. Eric Roeland at UC San Diego's Moores Cancer Center. The study is randomized to evaluate overall survival in patients treated with Xilonix and will be conducted initially in the United States before expanding elsewhere. A total enrollment of approximately 650 patients is expected. Study completion is anticipated in late 2014 with results potentially enabling marketing approval. XBiotech announced FDA Fast Track Designation for Xilonix in this indication at the end of last year.
Xilonix is a first-in-class True Human™ antibody. The therapy is designed to block cancer-related chronic inflammation, thereby inhibiting tumor growth and metastasis—and the development of lethal complications from cancer such as cachexia.