Press Release
XBiotech Completes Enrollment for Xilonix(TM) Phase III Registration Study in Europe
Dr.
Mr. Simard further stated, "Robust enrollment speaks to the support Xilonix gained among caregivers and patients. Keep in mind that
The Company's Xilonix therapeutic monoclonal antibody targets the molecular signaling known to stimulate growth of blood vessels and breakdown of connective tissue. The same signals may be involved in metastasis and messaging to the brain to cause pain, fatigue, anxiety, appetite suppression and hypermetabolic syndrome seen in advanced cancer. Earlier observations of Xilonix therapy in advanced cancer patients suggested physical recovery that strongly correlated with significant improvement in survival in colorectal cancer (Hong et al. Lancet Oncology 2014). These findings formed the basis for developing this unique regulatory pathway in
The Phase III trial is evaluating the efficacy of Xilonix in patients with metastatic colorectal cancer that is refractory to standard therapy. The trial design is double-blind, placebo-controlled and randomizes patients (2:1) to Xilonix plus best supportive care (BSC), or to placebo plus BSC. Eligible patients have metastatic colorectal cancer, have progressed on an oxaliplatin- and irinotecan-based regimen and are experiencing symptoms due to their underlying malignancy. The co-primary endpoint of improvement in lean body mass and improvement in quality of life is assessed after eight weeks of therapy, using whole body DEXA scanning for body composition assessment and the validated EORTC QLQ-C30 questionnaire for life quality assessment. The co-primary endpoints were designed to capture important surrogates for anti-cancer treatment effect, especially those that have been found in the past to correlate independently with improved overall survival. After completing assessment of the primary endpoint at eight weeks, patients are eligible to cross over into an open label extension of Xilonix.
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