XBiotech Xilonix Positive In Phase III Colorectal Cancer Study

XBiotech, Inc. (NASDAQ:XBIT) announced positive results from a phase III study on its lead candidate, Xilonix, for the treatment of advanced colorectal cancer (CRC).

Xilonix specifically targets and neutralizes interleukin-1 alpha (IL-1a), a molecule known to promote angiogenesis, growth and spread of tumors, and mediate symptoms such as metabolic dysregulation, fatigue and anxiety associated with advanced cancer.

Patients (n=309) enrolled in the study were randomized in the ratio of 2:1 to receive either Xilonix plus best supportive care (BSC) or placebo plus BSC.

Data from the study revealed a 76% relative improvement in the clinical response rate (CRR) after 8 weeks of therapy compared to placebo. Patients treated with Xilonix also demonstrated a clinical benefit. The candidate was generally well tolerated. Notably, there was a lack of toxicity associated with Xilonix in the study. Results were presented at the European Society of Medical Oncology (ESMO) World Congress on Gastrointestinal Cancer.

The study was developed in collaboration with the Scientific Advice Working Group at the European Medicines Agency (EMA). In Apr 2016, the EMA’s the Committee for Medicinal Products for Human Use (CHMP) granted accelerated review to Xilonix for the treatment of advanced CRC. A decision on the product’s marketing approval should be out as early as the fourth quarter of 2016.

Meanwhile, in the U.S., Xilonix is in phase III studies and the candidate enjoys Fast Track status for the treatment of advanced colorectal cancer. We expect investor focus to remain on further development updates on Xilonix from the company.

CRC, the second leading cause of malignancy, is estimated to be diagnosed in approximately 470,000 individuals in the EU this year.

Drugs that are currently approved for the treatment of CRC include Erbitux, Stivarga, Zaltrap (in combination with chemotherapy) and Cyramza (in combination with FOLFIRI).

XBiotech currently carries a Zacks Rank #2 (Buy). Investors interested in the health care sector may also consider Bristol-Myers Squibb Company (NYSE:BMY) , ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) and Pfizer Inc. (NYSE:PFE) . Each stocks sport a Zacks Rank #1 (Strong Buy).

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