XBiotech Announces Collaboration with US Oncology Research in Pivotal Phase III Trial for Anti-Cancer Drug Xilonix™

Sep 18, 2013, 10:00 ET from XBiotech

AUSTIN, Texas, Sept. 18, 2013 /PRNewswire/ -- XBiotech, a privately held biotechnology company, announced today its collaboration with US Oncology Research to conduct a pivotal Phase III Trial for colorectal cancer.

Through the collaboration, US Oncology Research will leverage its national network of affiliated oncology centers to treat patients with XBiotech's new anti-cancer therapy and report clinical outcomes. Patients enrolled in the trial will receive at least the current standard of care. With nearly 225 affiliated treatment research locations, US Oncology Research is one of the largest organizations in America focused on bringing physicians, clinics and patients together for innovative cancer care. Based on earlier clinical studies, it's anticipated that XBiotech's new therapy for colorectal cancer could show an improved survival rate for colorectal cancer patients, while at the same time facilitate recovery from the effects of cachexia, which is present in most patients with advanced colorectal cancer.

Xilonix™ is a first-in-class True Human™ antibody that blocks inflammation involved in tumor growth and metastasis. Sterile inflammation caused by malignant tumors is known to stimulate angiogenesis and tissue matrix remodeling, key steps in ongoing tumor growth and spread. Patients receiving Xilonix in an earlier study have shown improved overall survival and recovery of lean body tissue. US Oncology Research will join XBiotech's pivotal Phase III study, which has been granted FDA Fast Track status. XBiotech plans to have 100 sites in the United States, with results intended to provide the basis for marketing approval.

John Simard, CEO of XBiotech, commented "US Oncology Research is a premier cancer research organization with a rich history of innovation and superb attention to patient needs. Its reach to cancer patients across the country is simply extraordinary. We are thus gratified to be working together with US Oncology Research to expand availability of this new and important drug to more cancer patients."

Supported by McKesson Specialty Health and The US Oncology Network, US Oncology Research draws from a network of experienced investigators and dedicated clinical staff who specialize in Phase I through Phase IV oncology clinical trials. US Oncology Research serves approximately 80 research sites and nearly 225 locations managing about 225 active trials at any given time. Physicians in the research network have enrolled more than 56,000 patients in nearly 1,300 trials since inception in 1992 and have contributed to the development of 46 cancer therapies approved by the FDA. For more information call (800) 482-6700 or visit www.usoncology.com/oncologists.

XBiotech is leading the commercialization of biological therapies—including the discovery and development of True Human™ antibodies. The Company's lead product candidate—in Phase III clinical studies—represents a novel, breakthrough treatment for advanced colorectal cancer. XBiotech has also developed manufacturing technology to reduce infrastructure needs, lessen capital requirements and reduce lead times for biological drugs, ushering in a new era for cost and development efficiency in the biopharmaceutical industry.


Ashley Otero

Claire Crye
US Oncology Research