XBiotech held an Investigator Conference on Friday, April 24th in Austin, TX in preparation for initiation of the revised U.S. Phase 3 colorectal cancer study. The Company hosted more than 40 doctors and other healthcare professionals who are recruiting patients into the study. The meeting included talks from John Simard (President and CEO, XBiotech, Inc.) on targeting IL-1α in cancer, Dr. Michael Stecher (Medical Director, XBiotech, Inc.) on key changes to the revised protocol, as well as Dr. George Fisher (Principal Investigator of the study and Professor of Medicine, Stanford University School of Medicine) on results from the initial study, which he has previously presented at ASCO GI in January 2015.
The double-blind placebo controlled study is evaluating XBiotech’s monoclonal True Human™ antibody therapy Xilonix™—designed to block chronic inflammation associated with malignant tumor growth—for improving survival in metastatic colorectal cancer patients. The Phase 3 study was initially launched in March 2013 and was recruiting patients at more than 60 cancer centers in the United States. The study was halted to propose changes in inclusion criteria to the FDA to allow for more patients to be eligible for enrollment. Many of the attendees at Friday’s meeting had patients enrolled in the earlier study.
Dr. George Fisher commented, “I am happy that so many enthusiastic oncologists representing cancer centers throughout the United States met to discuss the launch of this revised study for patients with advanced colorectal cancer. Xilonix™ is intended to target the inflammatory environment of tumor cells and in so doing, slow the growth and spread of the cancer while improving the symptoms associated with advanced disease. Preliminary results have been encouraging and the absence of serious side effects would be a welcome change from standard chemotherapy agents.”