AUSTIN, Texas, Jan. 07, 2016 (GLOBE NEWSWIRE) -- XBiotech (NASDAQ:XBIT), developer of True Human™ therapeutic antibodies, announced today the completion of the second dose cohort in its Phase 1/2 clinical study of 514G3, its novel True Human monoclonal antibody therapy intended to treat all forms of Staphylococcus aureus infections, including Methicillin-resistant S. aureus (MRSA). Having met this milestone, XBiotech will advance to the third dose level in the Phase 1 portion of the study. The dose will be increased by a factor of four, and represents the final of three planned dosing cohorts.
514G3 was developed from a human donor with natural antibodies effective at neutralizing MRSA and non-MRSA forms of S. aureus. 514G3 knocks out the principle immune evasion mechanism of the bacteria, allowing white blood cells to detect and destroy the bacteria. 514G3 is expected to treat all strains of S. aureus and can be used without consideration for strain-specific resistance to various antibiotics. As a True Human monoclonal antibody, 514G3 is expected to be well tolerated without the side effects or risks of antibiotics.
John Simard, CEO of XBiotech, said, “Safety data review from the second dose cohort revealed no dose limiting toxicities. We are eager to advance to the final dose cohort and move toward the Phase 2 portion of the study. This program is representative of an exciting franchise XBiotech is building to treat a variety of life-threatening infectious diseases.”
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 Southeast Asia. Hospitalized patients with S. aureus bacteremia will be randomized to receive 514G3 plus standard of care antibiotics or placebo plus antibiotics. The Phase 1 portion of the study is a dose escalation, which will determine the maximum tolerated dose, followed by a Phase 2 study designed to assess safety and preliminary efficacy against S. aureus infection. 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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