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  • XenoPort, Inc. (XNPT) Submits New Drug Application For Its MS Drug To FDA 0 comments
    Jun 1, 2012 2:03 PM | about stocks: XNPT

    XenoPort is a biopharmaceutical company focused on developing and commercializing a portfolio of product candidates for the potential treatment of neurological disorders. One such drug candidate, XP23829, is designed to treat multiple sclerosis (NYSE:MS).

    The company today announced that it has submitted an Investigational New Drug application to the U.S. Food and Drug Administration to begin clinical studies of XP23829 as a treatment for relapsing-remitting multiple sclerosis (NYSE:RRMS). This type of MS is characterized by relapses during which time new symptoms can appear and old symptoms resurface or worsen. The relapses are followed by periods of remission during which time the person fully or partially recovers.

    Following clearance of the application by the FDA, the first Phase 1 clinical trial to be conducted in healthy subjects will begin. The study will examine the safety, tolerability, and pharmacokinetics of XP23829 and the performance of four different formulations of the drug designed to have different drug release mechanisms and/or time profiles.

    The company's drug candidate was also recently demonstrated to be effective in an animal model of psoriasis. XenoPort's CEO, Ronald W. Barrett, Ph.D., spoke about the company's goal for XP23839 and said "Our long-term goal is to create a best-in-class fumaric acid ester-based medicine for the potential treatment of RRMS and/or psoriasis."

    For additional information about XenoPort and its portfolio of drug candidates, please visit the company's website at www.XenoPort.com

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    Stocks: XNPT
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