AUSTIN, Texas, Oct. 26, 2015 (GLOBE NEWSWIRE) -- XBiotech (NASDAQ:XBIT), the world's leading developer of next-generation True Human™ therapeutic antibodies, announced today the launch of a research and development program to develop a first-in-class oral monoclonal antibody against Clostridium difficile (C. difficile) infection. Using its proprietary True Human technology, the Company has begun screening human blood samples from donors to identify and clone a therapeutic antibody candidate from individuals with natural immunity to C. difficile infection.
C. difficile is the causative organism of antibiotic-associated pseudomembranous colitis, a potentially devastating inflammatory condition of the colon. The incidence of C. difficile infection has risen sharply over the last two decades and today is a leading cause of morbidity and mortality in hospital-acquired infections in the U.S. According to the U.S. Centers for Disease Control and Prevention (CDC), C. difficile is estimated to have caused almost half a million infections in the U.S. in 2011, with 29,000 deaths, often occurring within 30 days of initial diagnosis. Eight out of 10 deaths related to C. difficile infection in the U.S. occur in patients 65 years of age or older, where recurrent infections are common, and estimated treatment cost per infection ranges from $6,000-$9,000.
John Simard, President and CEO of XBiotech, stated, "This program represents more than the addition of a new anti-infective product to our development pipeline. A successful True Human candidate could be the first oral monoclonal antibody against C. difficile, and a model for an oral antibody therapy approach. Recent outbreaks and increased virulence of C. difficile suggest the urgent need to identify novel approaches to treat the disease. We are eager to bring XBiotech's technology to develop a potential safe and effective therapy for this disease."
About C. difficile infection
C. difficile infection occurs most often in patients—such as those in healthcare settings, especially hospitals or nursing homes—who recently took certain antibiotics or other medications. The incidence of C. difficile infection is higher in certain patient populations, including people 65 years of age or older, and in patients with compromised immune systems due to an underlying disease or from treatment. Recurrence is a major challenge in C. difficile infection, with approximately one-in-four patients experiencing a recurrence after the initial episode, and more than 40 percent of these patients having further C. difficile recurrence.
Current treatments for C. difficile include stopping treatment with the antibiotic-associated infection, if possible, and treatment with one of a limited number of antibiotics that have anti-C. difficile activity. For patients with severe pain, organ failure or inflammation of the lining of the abdominal wall, surgery to remove the diseased portion of the colon may be the only option. The use of monoclonal antibodies against C. difficile toxin has been investigated in animal models and human clinical trials as an alternative to or in combination with traditional antibiotic therapy as treatment for C. difficile infection.
XBiotech is pioneering the discovery and development of targeted antibodies based on its True Human™ technology. The company's mission is to rethink the way antibody medicines are discovered and commercialized by advancing its robust pipeline of human antibodies for treating serious diseases such as cancer, inflammatory conditions and infectious diseases. XBiotech's lead product, Xilonix™, is a potential breakthrough antibody therapy that is currently the subject of two pivotal clinical studies for treating patients with advanced colorectal cancer. Xilonix specifically targets and neutralizes interleukin-1 alpha (IL-1a), a molecule known to promote angiogenesis, growth and spread of tumors, as well as mediate symptoms such as metabolic dysregulation, fatigue and anxiety associated with advanced cancer. XBiotech's True Human antibodies are cloned directly from individual donors who possess natural immunity against certain diseases. For more information, visit www.xbiotech.com.
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