XBiotech Presents Positive Results From Pivotal Phase III Trial Of Xilonix

(RTTNews) - XBiotech Inc. (XBIT) presented positive results from a pivotal Phase III trial of Xilonix, its lead monoclonal (IgG1k) antibody immunotherapy for the treatment of advanced colorectal cancer.

In the study, Xilonix-treated patients with advanced disease and multiple symptoms known to inversely correlate with overall survival experienced a 76% relative increase in clinical response rate (CRR), a novel measure of anti-cancer activity, after 8 weeks of therapy compared to placebo (33% vs. 19%, respectively; p=.0045).

In addition, clinical response correlated with improved overall survival. Among responders (in both treatment and placebo arms), clinical response was associated with a 2.7-fold increase in overall survival (11.5 versus 4.2 months in responders vs. non-responders, respectively).

Overall survival was not compared between treatment arms because after 8 weeks, all patients were eligible to receive study drug. Treatment with Xilonix was well tolerated, with an adverse event profile comparable to placebo. The data were presented at the 18th European Society of Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer in Barcelona, Spain.

John Simard, XBiotech Founder, President and Chief Executive Officer, said, "We believe these data demonstrate that our True Human monoclonal antibody targeting interleukin-1 alpha has the potential to meet this critical need."

Xilonix, which has been granted accelerated review by the European Medicines Agency (EMA), expects an approval decision as early as fourth quarter 2016.

XBIT closed Friday's regular trading session up 29 percent at $24.90.