BACKGROUND:Daclizumab high-yield process (DAC HYP) is a humanized anti-CD25 monoclonal antibody that inhibits high-affinity interleukin-2 receptor signaling. OBJECTIVE:The objective of this paper is to assess the proportion of DAC HYP- versus placebo-treated patients who were free from disease activity. METHODS: SELECT was a randomized, double-blind, multicenter study of DAC HYP 150 mg or 300 mg, or placebo, administered subcutaneously every four weeks for 52 weeks. In this post-hoc analysis of the SELECT trial, 'disease-activity free' was defined as completion through week 52 without relapses or confirmed three-month disability progression (clinical), with no new/newly enlarging T2-hyperintense lesions and no new gadolinium-enhancing lesions at the week 52 scan (radiological). Primary analyses were based on logistic regression controlling for baseline characteristics. RESULTS: More DAC HYP-treated (39%, n = 156) versus placebo-treated patients (11%, n = 22) were disease-activity free (odds ratio (95% confidence interval), 6.18 (3.71-10.32); p < 0.0001). Furthermore, 77% and 48% of DAC HYP-treated patients were free from clinical or radiological disease activity, respectively, compared with 60% and 18% of placebo-treated patients. CONCLUSION:At one year, DAC HYP resulted in a meaningful increase in the proportion of relapsing-remitting MS patients who were disease-activity free versus placebo.
Here are some more results from the daclizumab study, that profG has talked about previously. Isn't interesting that news of SELECT were published in 2011..So remember the issue about embargo and the ingelfinger rule. But this is a good example how investors get to know things first.
Late Breaking News II. Saturday, October 13, 2012, 09:15 - 09:30. Primary results of the SELECTION trial of daclizumab HYP in relapsing multiple sclerosis. G. Giovannoni, R. Gold, K. Selmaj, E. Havrdova, X. Montalban, E.-W.