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XBiotech's True Human antibody gains Fast Track.

Filings: XBiotech has been granted Fast Track Designation for its novel True Human monoclonal antibody therapy intended to treat all forms of Staphylococcus aureus infections, including Methicillin-resistant S. aureus (MRSA).

XBiotech's antibody therapy, known as 514G3, is currently being evaluated in a Phase I/II study and was developed from a human donor with natural antibodies effective at neutralizing MRSA and non-MRSA forms of S. aureus. The drug has been shown to knock out the principle immune evasion mechanism of the bacteria, allowing white blood cells to detect and destroy the bacteria. The drug is expected to treat all strains of MRSA 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.

Fast Track designation aims to expedite clinical development and regulatory review and is intended for drugs that are designed to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

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Title Annotation:TRIALS & FILINGS
Publication:Contract Pharma
Date:Nov 1, 2015
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