elevations beyond 5X the ULN, 1 cancer, and 3 cases of autoimmune disorders (including 1 fatal hepatitis) .Some researchers think that the autoimmune problems may be serious enough to jeopardize the drug´s future in MS [7].
17/10/2012 09:40:01
Aug 11: Top-line data from PIIb SELECT trial. Daclizumab high-yield process (DAC HYP) significantly reduced annualised relapse rate by 54% in 150mg dose arm, and by 50% in 300mg dose arm, vs. placebo, at one year. DAC HYP met secondary endpoints for the 150 mg and 300 mg arms, respectively, providing a highly statistically significant reduction in the cumulative number of new gadolinium-enhancing lesions between weeks 8 and 24 (69%; 78%); in the number of new or newly enlarging T2 hyperintense lesions at one year (70%; 79%); and in the reduction in the proportion of patients who relapsed (55%; 51%). DAC HYP also showed a trend toward improvement in quality of life measures at one year. DAC HYP reduced the risk of sustained disability progression at one year Overall incidence of adverse events and treatment discontinuations were similar in all study arms.[6]
09/08/2011 15:49:55
May 10: First patient enrolled in the global PIII DECIDE study (NCT01064401) comparing monthly subcutaneous daclizumab vs weekly IM interferon beta-1a (AVONEX®) in patients with relapsing-remitting multiple sclerosis (RRMS). The randomized, double-blind 2-3 year montherapy study is expected to enroll 1,500 RRMS patients in 28 countries. DECIDE (Daclizumab HYP Efficacy Compared to Interferon Beta 1-a Study for Multiple Sclerosis) will include patients between the ages of 18 to 55 years with an Expanded Disability Status Scale (EDSS) score ranging from 0.0 to 5.0. The primary endpoint is annualized relapse rate; other endpoints include functional decline, disability progression and quality of life. Estimated study completion date is Nov 13 [5].
24/05/2010 21:24:44
Feb 10: PII data from the CHOICE study published in the online edition of The Lancet Neurology, ahead of publication in the April issue. The study enrolled 230 patients, ages 18 to 55 years, with active relapsing MS who had an entry score of five or less on the Expanded Disability Status Scale (EDSS). The patients had to be taking a stable IFNβ regimen for a minimum of six months prior to enrollment. During the year prior to enrollment, patients had to have experienced at least one MS relapse or incurred at least one MS lesion of the brain or spinal cord while on a stable IFNβ regimen. Patients were randomised to one of 3 groups: 2mg/kg daclizumab every two weeks (DAC high dose/ IFNβ); 1mg/kg daclizumab every four weeks (DAC low dose/ IFNβ); or placebo (placebo/ IFNβ). Compared with placebo/IFNβ therapy, there was a 72 % reduction in the number of new or enlarged gadolinium contrast-enhancing lesions (Gd-CELs – primary endpoint) between weeks eight and 24 in the DAC high dose/IFNβ group (p=0.004, 95% CI 34%, 88%) and a 25% reduction in the DAC low dose/IFNβ group (p=0.51, 95% CI -76%, 68%). In addition, treatment with daclizumab resulted in a 7-8 fold increase of CD56bright NK cells (a subset of the natural killer (NK) cells that help regulate the immune system) which was associated with a decrease in disease activity. Daclizumab was well-tolerated; common adverse events occurred with a similar frequency in each treatment group [4].
18/02/2010 08:59:25
Aug 09: The company will request a Special Protocol Assessment from the FDA for a PIII stu |
