Poster to Outline Details of U.S. Phase III Study of MABp1 in Patients with Advanced Colorectal Cancer (XCITE)
AUSTIN, TX, January 21, 2016 – XBiotech (NASDAQ: XBIT), developer of True Human™ therapeutic antibodies, today announced that on January 23, 2016, Dr. Michael Stecher, the Company’s Medical Director, will present as part of the Trials in Progress Poster Session at the American Society of Clinical Oncology (ASCO) 2016 Gastrointestinal Cancers Symposium in San Francisco, CA. The poster presentation, titled “Phase III double-blinded, placebo-controlled study of MABp1 for improving survival in metastatic colorectal cancer,” is part of a special update for the gastrointestinal oncology community on XCITE, an ongoing FDA Fast Tracked, Pivotal Phase III study of XBiotech’s cancer drug Xilonix™ for the treatment of metastatic colorectal cancer.
The poster will outline the details of XCITE, which is a global study of 600 patients with a primary endpoint of overall survival, and secondary endpoints of progression free survival, overall response rate, change in lean body mass, and quality of life. The study is powered to show a clinically meaningful improvement in overall survival, evaluated by log-rank test with a one-sided alpha of 0.025. Enrollment is currently underway, and results of the first interim analysis are expected in late 2016. The poster will also highlight positive results from a previous Phase I/II trial, which showed a survival benefit and symptomatic recovery in patients with advanced colorectal cancer.
Michael Stecher, M.D., the Company’s Medical Director, stated, “Having successfully completed our European Phase III study using novel clinical endpoints developed with the EMA, I am gratified to have this opportunity to continue our positive momentum and highlight our global FDA trial for the GI cancer community.”
The Gastrointestinal (GI) Cancers Symposium is a three-day specialized oncology event designed to provide scientific and educational content for members of the GI cancer care and research community.
About XBiotech
XBiotech is pioneering the discovery and development of targeted antibodies based on its True Human™ technology. The company’s mission is to rethink the way antibody medicines are discovered and commercialized by advancing its robust pipeline of human antibodies for treating serious diseases such as cancer, inflammatory conditions and infectious diseases. XBiotech’s lead product, Xilonix™, is a potential breakthrough antibody therapy that is currently the subject of two pivotal clinical studies for treating patients with advanced colorectal cancer. Xilonix specifically targets and neutralizes interleukin-1 alpha (IL-1a), a molecule known to promote angiogenesis, growth and spread of tumors, as well as mediate symptoms such as metabolic dysregulation, fatigue and anxiety associated with advanced cancer. XBiotech’s True Human antibodies are cloned directly from individual donors who possess natural immunity against certain diseases. For more information, visit www.xbiotech.com.
