BIOTECHNOLOGY, Oct. 21, 2015 (GLOBE NEWSWIRE) -- XBiotech (NASDAQ:XBIT), the world's leading developer of next-generation True Human™ therapeutic antibodies, announced that it held an investigator conference on October 14th in Austin, TX for its Phase 1/2 clinical study of a novel True Human monoclonal antibody therapy intended to treat all forms of Staphylococcus aureus infections, including methicillin-resistant S. aureus (MRSA). The Company says clinical data were presented that it believes provides evidence that the therapy can work in patients to mediate immune clearance of S. aureus. XBiotech says it plans to submit these data to the FDA as it refines its Fast-Track development strategy for the therapy.
The Company presented findings that showed a direct correlation with the pharmacokinetics of its antibody therapy and the ability of patient blood to mediate clearance of S. aureus.
XBiotech hosted 30 attendees, including doctors, nurses and coordinators from five participating sites and others responsible for the administration of the trial. The conference featured a talk by Dr. Mark E. Rupp, Principal Investigator of the study, on the growing impact of S. aureus bacteremia in the United States, the devastating consequences of the disease in terms of mortality and morbidity, and the need for new therapies. Dr. Rupp, a world expert on S. aureus infections, is Professor and Chief, Division of Infectious Diseases and Medical Director of the Department of Infection Control & Epidemiology at the University of Nebraska.
Dr. Rupp commented, "Infection due to Staphylococcus aureus is a very significant clinical problem that results in a substantial amount of death and suffering on a worldwide basis. The ongoing emergence and spread of multi-drug resistant S. aureus, including MRSA, clearly indicates a critical need for novel, non-antibiotic, adjunctive and preventive therapy. The anti-S. aureus monoclonal antibody 514G3 shows great promise in laboratory and in-vivo experiments and may be just what is needed to combat serious infections due to S. aureus. This novel product deserves serious and thorough scrutiny."
John Simard, President and CEO of XBiotech, stated, "Early clinical data has provided compelling evidence that the antibody therapy can play a crucial role to enable elimination of S. aureus by the immune system. We were inspired by the keen interest in the therapy that we witnessed among clinical investigators. We are working diligently to build on our findings to advance the clinical program as quickly as possible to address the urgent need for an S. aureus therapy."
The randomized, placebo-controlled, Phase 1/2 study is designed to evaluate dosing, safety and efficacy of 514G3 and will enroll 52 patients at approximately 16 clinical sites in the United States, Europe and Asia. Hospitalized patients with S. aureus bacteremia will be randomized to receive 514G3 plus standard of care antibiotics or placebo plus standard of care antibiotics. The study will be unblinded during the Phase 1 dose escalation stage, where the maximum tolerated dose will be determined, followed by a double-blinded Phase 2 study designed to further assess safety and efficacy. Efficacy measures include time to clearance of bacteremia, as measured by blood culture, duration of fever and length of hospitalization. For more information about the study, visit www.clinicaltrials.gov.
XBiotech is pioneering 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 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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