dy planned to start 1H 2010. They are anticipating approval Jul 11 [3].
02/09/2009 08:41:09
The PIIb SELECT study is a placebo-controlled, dose-ranging study of monotherapy in patients with relapsing-remitting MS. 600 patients will be randomized to receive 150 mg DAC HYP, 300 mg DAC HYP or placebo every four weeks suncutaneously. The primary endpoint is reduction in the annualized relapse rate. Secondary endpoints include reductions of new or enlarged gadolinium-enhanced magnetic resonance imaging lesions. SELECT is considered to be the first of two registration-enabling trials required by regulatory authorities [3].
02/09/2009 08:40:55
The PIIb SELECT trial (NCT00390221) of DAC HYP monotherapy started in Feb 08 in EU, Russia, India and Australia and is expected to complete in Nov 11. In Mar 09, It was agreed to increase patient numbers from 300 to 600, and to change the primary endpoint to annualised relapse rate. The independent Safety Monitoring Committee has conducted a planned interim futility analysis of a subset of the data, and has recommended the continuation of the trial. Regulatory authorities have stated that a positive outcome of this phase II trial plus a phase III trial would be sufficient to support registration of daclizumab [2].
02/09/2009 08:29:28
Facet Biotech Corporation has developed a high-yield manufacturing process for daclizumab (DAC HYP), producing a high concentration, liquid formulation for subcutaneous injection for the treatment of MS [2].
02/09/2009 08:26:10
CHOICE trial showed benefit in reducing number of lesions when added to beta-interferon in pts with relapsing MS (1)
Evidence Based eva luations
NIHR HSRIC http://www.hsric.nihr.ac.uk/topics/daclizumab-high-yield-process-for-relapsing-forms-of-multiple-sclerosis-first-or-second-line/
References
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