We and our collaboration partner, Biogen Idec, are currently testing daclizumab as a new therapy for relapsing-remitting multiple sclerosis (MS).

CHOICE Trial

The CHOICE trial was a phase 2, randomized, double-blind, placebo-controlled trial of daclizumab added to interferon beta therapy in 230 patients with relapsing MS. The trial tested two dosing regimens of daclizumab administered as a subcutaneous injection: 1 mg/kg daclizumab administered every four weeks and 2 mg/kg daclizumab administered every two weeks. Results of the study, presented in late 2007, showed that the addition of daclizumab, administered at 2 mg/kg every two weeks to interferon beta therapy, significantly reduced new or enlarged gadolinium-enhancing lesions at week 24, when compared to interferon beta therapy alone.

Daclizumab treatment was generally well-tolerated. Common adverse events were similar in all treatment arms. Grade 3 adverse events were observed in 24 percent of DAC/IFNß-treated patients and 14 percent of placebo/IFNß-treated patients. The most frequent grade 3 adverse events were infections, which occurred in 7 percent of DAC/IFNß-treated patients and 3 percent of placebo/IFNß-treated patients. There were no opportunistic infections or deaths, and all infections resolved with standard therapies.

SELECT Trial

The SELECT trial is a phase 2b, randomized, double-blind study testing daclizumab as a monotherapy versus placebo in approximately 600 patients with relapsing MS. The study is testing two dose levels, 150 mg and 300 mg, administered every four weeks as a subcutaneous injection. The primary endpoint of the trial is annualized relapse rate after 48 weeks of treatment.

In July 2009, an interim futility analysis was performed to ensure patient safety and to evaluate whether the SELECT trial should continue. An independent safety monitoring committee reviewed the interim data and recommended the continuation of the SELECT study.

The SELECT trial remains ongoing.

DECIDE Trial

The DECIDE trial is a global phase 3, randomized, double-blind, active-comparator study of daclizumab as a monotherapy versus interferon beta 1-a(AVONEX^®) in patients with relapsing-remitting multiple sclerosis (RRMS). Approximately 1,500 patients with RRMS in 28 countries are expected to be enrolled. All study participants will receive either an injection of daclizumab 150 mg administered subcutaneously once every four weeks and weekly injections of placebo, or weekly injections of interferon beta 1-a(AVONEX^®) and an injection of placebo once every four weeks. The primary objective of the trial is to determine the efficacy of daclizumab compared to interferon beta 1-a in preventing MS relapse, with annualized relapse rate as the primary endpoint. The study will also examine the efficacy of daclizumab compared to interferon beta 1-a(AVONEX^®) in slowing functional decline and disability progression and in maintaining quality of life.

The DECIDE trial is expected to begin in the second quarter of 2010.

Please visit our daclizumab publications page to view our most recent data presentations for this program.

For inquiries about our clinical trials, please call our information line at 650 454-1400 or visit the National Institutes of Health website (http://www.clinicaltrials.gov).

CHOICE Presentation