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Thread: XenoPort Announces Initiation of Clinical Trials

  1. #1
    Senior Member Max's Avatar
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    Jul 2001
    Montreal,Province of Quebec, CANADA

    XenoPort Announces Initiation of Clinical Trials

    XenoPort Announces Initiation of Clinical Trials

  2. #2
    It is an anti-spasticity treatment, a form of baclofen.

    XP19986 Phase 2 Clinical Trial in Spinal Cord Injury Patients with Spasticity

    XenoPort's multiple-dose, randomized, placebo-controlled, crossover Phase 2 clinical trial of XP19986 is designed to evaluate the efficacy, safety and tolerability of a sustained-release formulation (designated as SR1) of XP19986 in patients with spasticity due to spinal cord injury. XenoPort believes that the SR1 formulation of XP19986, which provides sustained drug exposure over 12 hours, could provide improved therapy when dosed twice a day in spasticity patients who are underserved by current therapies that require dosing three or four times per day.

    The Phase 2 clinical trial is being conducted at multiple study centers in the United States. Three doses of XP19986 are being assessed in a randomized crossover comparison versus placebo. Twelve subjects will be enrolled in each dose level. Eligible subjects undergo a washout and baseline period, followed by XP19986 (10 mg, 20 mg or 30 mg) or placebo, administered twice a day in the first treatment segment. After a washout period, each subject receives the other treatment in the second treatment segment. The primary outcome measure in this study is the Ashworth Scale assessment of muscle tone.


    About XP19986

    XP19986 is designed to overcome certain deficiencies of baclofen, a currently marketed generic drug approved for the treatment of spasticity. Baclofen is a racemic drug (a 50:50 mixture of R- and S-isomers). Studies have shown that the beneficial therapeutic properties of baclofen are attributable to the R-isomer of baclofen only. R-baclofen is a selective agonist of GABA-B receptors. Baclofen has a short half-life in blood after oral dosing, which necessitates frequent daily dosing and is associated with unwanted side effects. Absorption of baclofen in the colon is limited, which has prevented the development of a sustained-release formulation that could address these deficiencies.

    XP19986 is a new chemical entity that is a Transported Prodrug of R-baclofen. XP19986 is designed to engage natural nutrient transport mechanisms found on intestinal cell membranes, thereby gaining efficient entrance into the bloodstream. XP19986 is then rapidly converted to R-baclofen by high-capacity enzymes. In addition to R-baclofen, the metabolic breakdown products of XP19986 are natural substances with favorable safety characteristics.

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