Clinical Development
The safety, tolerability, and pharmacokinetic profile of CDP323 have been evaluated in 75 female and male healthy volunteers in three separate Phase 1 studies. CDP323 was well tolerated at oral doses up to 1000 mg given twice daily for 7 consecutive days with an adverse event profile comparable to that observed with placebo. There was no gender effect. The oral administration resulted in inhibition of VCAM-1 binding which could be maintained throughout a 12 or 24 hour dose interval at well tolerated doses
A Phase 2 study commenced in June 2007 in Europe and in the US. The study intends to enroll over 200 patients with relapsing MS who have failed earlier treatment with an interferon-beta and will compare two doses of the drug to placebo over a period of six months. The results are expected by the end of 2008.,
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