Press Release
XBiotech Announces Positive Results in European Phase III Study for Its Breakthrough Therapy for Colorectal Cancer
Significantly more patients treated with Xilonix were responders compared to those given placebo. One-third (33%) of the 207 patients randomized to Xilonix treatment met responder criteria, compared to less than one-fifth (19%) of the 102 placebo patients (p=0.009). Based on a modified intent to treat analysis plan, patients with missing endpoint data or those who received Xilonix instead of placebo were considered non-responders. In total, there were 333 patients enrolled in the study. As per the prospective analysis plan, 24 patients who failed to receive either Xilonix or placebo were excluded from analysis.
Patients were assessed for anti-tumor activity using a novel co-primary endpoint. X-ray imaging was used to quantify change in lean body mass and health status was assessed based on patient-reported outcomes using the
The Xilonix therapeutic antibody uniquely blocks the inflammation that is believed to support tumor growth, spread and symptomatic effects of the disease. In the presence of progressive disease, patient condition is known to deteriorate. In the context of an antitumor therapy, the control or reversal of symptoms related to disease is considered to be evidence of anticancer activity and a prognosticator of better survival.
This study, developed in collaboration with the EMA, represents the first use of such a responder analysis in a controlled study for the development of an anticancer agent. Xilonix is thus the first anticancer agent evaluated using surrogate measures based on conservation of patient health status, and is believed to be the first anticancer therapy to demonstrate an ability to conserve or improve patient health status with treatment.
The Company plans to proceed with the marketing authorization process with the EMA and other jurisdictions.
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CONTACT:Ashley Otero XBiotech aotero@xbiotech.com 512.386.2930Tiberend Strategic Advisors, Inc. :Joshua Drumm , Ph.D. (investors) jdrumm@tiberend.com 212.375.2664Janine McCargo (media) jmccargo@tiberend.com 646.604.5150