On April 4, 2016 XBiotech Inc. (NASDAQ: XBIT) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted accelerated review for Marketing Authorization of Xilonix, the Company’s first-in-class True Human monoclonal (IgG1k) antibody treatment for advanced colorectal cancer (Press release, XBiotech, APR 4, 2016, View Source [SID:1234510424]). The CHMP grants accelerated review for medicines deemed to be of public health importance and that represent therapeutic innovation. The accelerated review procedure allows the CHMP to grant an opinion two months earlier than the normal 210-day procedure. With this action, a decision on Xilonix’s approval could come as early as third quarter 2016.
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Xilonix is XBiotech’s lead True Human therapeutic antibody and a potential breakthrough for patients with advanced colorectal cancer. Xilonix specifically targets and neutralizes interleukin-1 alpha (IL-1a), a molecule known to promote angiogenesis (the growth and spread of tumors), as well as mediate symptoms such as metabolic dysregulation (e.g., loss of weight and muscle mass), fatigue and anxiety associated with advanced cancer.
XBiotech recently received validation of its Marketing Authorization Application (MAA) for Xilonix based on results of a Phase III study, which showed a 76% relative improvement in response rate in patients treated with the antibody, as compared to placebo (p=0.0045). Patients treated in the Phase III study had colorectal tumors that were metastatic or inoperable, had failed all recommended forms of chemotherapy and most other forms of therapy, and suffered from symptoms including pain, fatigue, anorexia and wasting. The patients treated in the Phase III study were considered to represent a large patient population that is physically and emotionally exhausted from the disease and treatment-related toxicities.
"XBiotech is encouraged by CHMP’s action to grant accelerated review of Xilonix," said John Simard, Chairman, Chief Executive and founder of XBiotech. "There is an urgency to provide advanced colorectal cancer patients with access to new treatments that have been developed with their specific needs in mind."
In the U.S., Xilonix has received Fast Track designation by the Food and Drug Administration (FDA) for the treatment of advanced colorectal cancer.
About Colorectal Cancer
Colorectal cancer is the second leading cause of malignancy in the industrialized world. The incidence of colorectal cancer increases with economic development and aging, hence incidence is rising worldwide. In Europe, approximately 470,000 patients will be diagnosed with colorectal cancer in 2016, and half of this number will progress and ultimately succumb to the disease. Disease progression is associated with significant morbidity, functional impairment and failure of multiple therapies often with substantial toxicities. Patients with advanced disease are thus symptomatic and intolerant to further treatment-related morbidity. New anti-cancer options are needed for patients suffering from advanced colorectal cancer.
About XBiotech’s True Human Therapeutic Antibodies
Unlike antibodies found in other therapies, XBiotech’s True Human antibodies are 100 percent human and derived from healthy people with natural immunity to heal and protect others. By rethinking the approach to antibody therapy, XBiotech developed a proprietary technology to identify, isolate and manufacture human antibodies derived from the body that finally work in harmony with it.