Date: 2017-01-17
Type of information: Publication of results in a medical journal
phase: 3
Announcement: publication of results in The Lancet Oncology
Company: XBiotech (USA - TX)
Product: Xilonix™
Action mechanism: monoclonal antibody. Xilonix™ is the first monoclonal antibody to specifically target and neutralize interleukin-1 alpha (IL-1 alpha), one of the most potent inflammatory signaling molecules. The IL-1 pathway in general, and IL-1 alpha in particular, is a desirable target for anti-cancer therapy because of its potential role in both local and systemic effects of cancer. IL-1 alpha in the tumor microenvironment is known to promote angiogenesis as well as mediate symptoms such as metabolic dysregulation, fatigue and anxiety associated with advanced cancer.
Disease: advanced colorectal cancer
Therapeutic area: Cancer - Oncology
Country: Poland
Trial details: The primary objective of this study will be to assess how effective Xilonix is in the treatment of patients with symptomatic colorectal cancer. By blocking a substance that helps tumours grow and spread, Xilonix therapy may not only slow tumour growth, but also may improve symptoms of muscle loss, fatigue, appetite loss, and pain in patients with colorectal cancer. The effectiveness of the therapy 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 type of X-ray called a DEXA scanner. Improvement in pain, appetite loss, and fatigue will be measured with a questionnaire that is completed by patients enrolled on the trial. (NCT02138422)
Latest news: • On January 17, 2017, XBiotech announced the publication of results from its pivotal phase 3 trial of the Company’s lead monoclonal antibody therapy. The results were published in The Lancet Oncology in an article titled, “MABp1 as a Novel Antibody Treatment for Advanced Colorectal Cancer: A Randomised, Double-Blind, Placebo-Controlled, Phase 3 Study.” “The findings indicate what we believe to be the first evidence that antibodies produced as a result of a natural human immune response can play a role in regulating disease progression in cancer,” said Prof. Tamas Hickish, lead author and Chair of the European Phase 3 Study.
