XBiotech and EMA agree on Phase III registration study for treatment of colorectal cancer

XBiotech will soon launch its Phase III registration study in Europe to evaluate Xilonix in patients with treatment-resistant colorectal cancer. Cancer treatment centers in at least 6 countries will be involved in the registration study, which is expected to take 12 months to complete.

The agreement with the EMA was the culmination of extensive discussion around the scientific and clinical assessment of Xilonix therapy.

XBiotech has sought to establish a novel approach to evaluate treatment responses and efficacy of Xilonix in patients with advanced cancer.

The company is reportedly using a new, less harmful form of radiographic measure to assess patient responses. Using this novel method will also enable evaluation of Xilonix therapy in a short time frame, making the clinical study time and cost efficient.

XBiotech CEO John Simard noted establishing a registration path in Europe based on this innovative study design is an important milestone both for XBiotech and for the development of new therapies for treating advanced cancer.

"We are grateful for the efforts and input from the EMA to help XBiotech lead innovation for this area of oncology. From all points considered, this study represents a significant advance in the way we evaluate and ultimately treat cancer," Simard added.

Xilonix works to block a number of processes that tumors use to grow and spread. The pleiotropic activity of the drug is unique in that Xilonix inhibits the formation of tumor blood supply, relieves tumor-mediated suppression of natural immune responses, prevents the spread of tumor cells and reduces the negative metabolic effects of metastatic disease.