XBiotech has received FDA fast track designation for its anti-cachexia drug Xilonix, a first-in-class True Human antibody.
Xilonix blocks an inflammatory substance (IL-1a) produced by the body in response to tumor growth, which plays a role in cancer progression and the development of lethal symptoms such as cachexia.
XBiotech president and CEO John Simard said the Fast Track study design reflects that Xilonix will substantially prolong life in the advanced cancer population.
"That is why our clinical study examines overall survival compared to other anti-cachexia agents in development, which are only attempting to provide symptomatic relief to these patients," Simard added.
"We believe that this makes Xilonix a very important and unique therapy for a large patient population that currently has few other treatment options."
The therapeutic antibody was proven in a previous study to stop or reverse cachexia in about a third of all advanced cancer patients treated.
XBiotech anticipates launching a Phase III randomized, controlled study under the FDA's Fast Track program to evaluate overall survival in advanced colorectal cancer patients, suffering from cachexia, treated with Xilonix.