Press Release
XBiotech Secures Approval From Data Safety Monitoring Board to Continue Phase 3 Registration Study in Europe for Its Novel Cancer Immunotherapy
As part of the only planned DSMB review, the group was tasked with assessing what fraction of patients enrolled had completed all endpoints. Normally, not all patients enrolled make it through all the data endpoints. Based on these findings, the DSMB was to make a recommendation for increasing the patient sample size to maintain statistical power of the study. The DSMB made a recommendation for sample size increase that was within expectations and the Company states enrollment remains on pace to meet the completion timelines.
The primary objective of the double-blinded, placebo-controlled, multi-center study is to assess the effectiveness of Xilonix for treating patients with symptomatic colorectal cancer. Xilonix blocks interleukin-1 alpha (IL-1a), an inflammatory mediator that acts at the site of the tumor to stimulate growth of tumor blood supply and support tumor growth. In addition, IL-1a may aid circulating tumor cells to form new sites of metastasis and also be involved as a messenger in the brain, where it can trigger fatigue, anxiety and metabolic dysregulation seen in advanced cancer. In a previous study at MD Anderson, Xilonix therapy appeared to not only have anti-tumor effects and prolong survival, but also seemed to improve symptoms of muscle loss, fatigue, appetite loss, and pain in patients with advanced cancer.
In the current study, anti-tumor effect will be measured by assessing the change in these symptoms for patients treated with Xilonix versus those treated with placebo. Reversal of muscle loss will be assessed with a novel type of radiology called dual energy X-ray absorptiometry, or DEXA. Improvement in pain, appetite loss, and fatigue will be measured with a well-established and validated questionnaire that reliably assesses patient well being as reported by patients themselves.
About
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