Austin’s XBiotech is back in the news again today, as the company announced that its ongoing collaboration with the European Medicines Agency (EMA) has led to a much-needed regulatory path for the company’s lead product Xilonix, so that the drug can eventually be approved for use in the Eurozone for the treatment of colorectal cancer. XBiotech AG, the company’s European base of operations, is planning to launch its Phase III registration study in Europe for Xilonix to test the drug’s effectiveness in treatment-resistant colorectal cancer. The study is currently set to include cancer treatment centers in at least European 6 countries, and is expected to remain active for 12 months.
The agreement on a regulatory path between XBiotech and the EMA for Xilonix was the result of an extensive process to accurately determine the scientific and clinical assessment of the therapy. BioNews Texas has reported in the past on XBiotech’s innovative approach to target advanced cancer in patients with Xilonix and evaluate treatment responses and efficacy of the therapy. In order to optimize this assessment process, the company is now reportedly utilizing a new, “less harmful form of radiographic measure to assess patient responses, according to a company press release. “Using this novel method will also enable evaluation of Xilonix therapy in a short time frame, making the clinical study time and cost efficient.”
“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,” XBiotech’s CEO John Simard said. “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.”
What makes Xilonix unique is that it inhibits the growth and and spread of cancer tumors by blocking key processes. “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.”
“We have known of the harmful role of Interleukin-1 alpha on inflammation-driven tumor growth and tumor spread in mice for several years but with the introduction of Xilonix, we now see the benefit of suppressing Interleukin-1 alpha in patients without the side-effects of traditional chemotherapy, said Dr. Charles Dinarello, who first described Xilonix’s target, Interleukin-1 alpha in 1974, and is a world-renowned expert on tumor related inflammation. “Because of the lack of serious side-effects with Xilonix, the drug can be given repeatedly to combat colorectal cancer.”