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Isis Pharmaceuticals, Inc. Message Board

  • pottedplant07 pottedplant07 Jan 12, 2009 9:34 AM Flag

    New NEWS on Mipo!

    Potted just checked in . . .and saw the ISIS NEWS . . . Genzyme and Isis Begin New Clinical Trials of Mipomersen . . .

    Go to the Head-of-the-Class with ISIS!

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    • Potted, these are for additional indications the way I read it...correct?

      • 1 Reply to z_for_three
      • Z3 . . . ISIS and Genzyme talked about these "high-risk" patient groups previously . . . and NOW we see the DETAILS of the Mipo studies for each group . . . Genzyme primarily brought forth the apheresis-eligible patient population ( Potted thinks this procedure is more prevalent in Europe ) . . . Note that for these "high-risk" groups. . . the primary study endpoint is only reduction in LDL cholesterol! . . . from the report . . . "The trial currently screening patients will evaluate the safety and efficacy of mipomersen in patients with severe hypercholesterolemia who are on a maximally tolerated lipid-lowering regimen (previously referred to as apheresis-eligible patients). This phase 3 study includes patients who are not on LDL cholesterol apheresis but who have such severely elevated LDL-C levels that they are eligible for the procedure, and will enroll up to 75 patients. . . In addition, the companies recently initiated a phase 3 trial in hypercholesterolemic patients on maximally tolerated dosages of statins who are at high risk for coronary heart disease. This study will enroll up to 180 patients. The companies have also begun a new phase 2 study in high-risk, high-cholesterol patients who are intolerant to statins, which will enroll up to 30 patients. . . . All three new trials are double-blind, placebo-controlled studies in which patients will be randomized 2:1 to receive a 200 mg dose of mipomersen or placebo weekly for 26 weeks, with percent change in LDL-C as the primary endpoint."

        Go to the Head-of-the-Class with ISIS!

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