AUSTIN, Texas, Nov. 11, 2015 (GLOBE NEWSWIRE) -- XBiotech (NASDAQ:XBIT), developer of True Human™ therapeutic antibodies, announced today that it has already identified positive donors for its first anti-Clostridium difficile (C. difficile) product candidate. Just two weeks after initial screening of blood donations from healthy volunteers, XBiotech has identified donors that have antibody reactivity against its targeted moieties on the C. difficile bacteria. Identifying natural antibodies against C. difficile in the healthy population is the first step in the discovery process for True Human therapeutic antibodies. Since it is unknown at the onset whether or not natural antibodies will be present in the healthy population, the Company believes that identifying these antibodies, especially so quickly, is a good indication that they are important in protection against disease.
John Simard, President and CEO of XBiotech, stated, "Once again, we have demonstrated the remarkable efficiency of our True Human platform to identify leads for the development of natural human antibodies against disease. We look forward to now cloning the anti-C. difficile antibody genes, and potentially advancing a lead antibody toward clinical studies. With our C. difficile program we are attempting to do something quite extraordinary—unlike any other marketed antibody therapy, our goal is to develop the first oral-delivered monoclonal antibody therapy. Gut infection with C. difficile is a dreadful disease that attacks the most vulnerable, including the aged and infirm. An oral antibody therapy in this population could be a very important advance. We look forward to achieving further milestones in this program."
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 a new era in the discovery and development of targeted antibodies based on its True HumanTM technology. The company's mission is to rethink the way antibody medicines are discovered and commercialized by advancing its robust pipeline of truly natural 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 broad pipeline of True Human antibodies are able to potentially deliver unmatched safety and efficacy because they are cloned directly from individual donors who possess natural immunity against certain targeted diseases. As such, True Human antibodies retain their natural physiology and tolerance profile, having passed the rigors of immune selection in the body. For more information, visit www.xbiotech.com.
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