Well, here we go again . . .
>>CARLSBAD, Calif., Nov. 29 /PRNewswire/ -- Isis Pharmaceuticals, Inc. (Nasdaq: ISIP - news) announced today it has initiated a Phase III clinical trial of alicaforsen (ISIS 2302), an antisense inhibitor of intercellular adhesion molecule-1 (ICAM-1), in people with active Crohn's disease. The study will evaluate the safety and efficacy of alicaforsen at doses higher than previously studied in controlled trials.
This randomized, double-masked, placebo-controlled study is planned to enroll 150 patients at 40 sites in the United States and Canada. This trial is the first of two Phase III studies planned. The primary endpoint of the studies is clinical remission as defined by a Crohn's disease activity index score (CDAI) of less than 150, with no increase in the use of medications and no need for surgery. CDAI is a common clinical index scoring system of the severity of symptoms related to Crohn's disease.
``The cumulative data merits further investigation of this drug and we are pleased to continue the development of ISIS 2302 in Crohn's disease. A recent pilot study demonstrated safety and supported previous findings concluding a higher dose of ISIS 2302 may be effective in treating this disease,'' said F. Andrew Dorr, M.D., Isis' Vice President and Chief Medical Officer. ``We are hopeful this drug has the potential to help people with this devastating condition. There is clearly a need for new treatments.''<<
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Cheers, Tuck |
