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Aaron E. Miller, MD Professor of Neurology and Medical Director The Corinne Goldsmith PowerPoint Presentation
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Daclizumab High-Yield Process in Relapsing-Remitting Multiple Sclerosis (SELECT): A Randomised , Double-blind, Placebo-controlled Trial. Gavin Giovannoni , MBBCh , PhD Chair of Neurology Blizard Institute Barts and The London School of Medicine and Dentistry London, UK.

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Daclizumab High-Yield Process in Relapsing-Remitting Multiple Sclerosis (SELECT): A Randomised, Double-blind, Placebo-controlled Trial

  • Gavin Giovannoni, MBBCh, PhD
  • Chair of Neurology
  • BlizardInstitute
  • Barts and The London School of Medicine and Dentistry
  • London, UK

Aaron E. Miller, MD

Professor of Neurology and

Medical Director

The Corinne Goldsmith

Dickinson Center for

Multiple Sclerosis

Icahn School of Medicine at Mount Sinai

New York, NY

what is daclizumab high yield process hyp
What Is Daclizumab High Yield Process (HYP)?
  • Daclizumab is a humanized monoclonal antibody
    • Blocks CD25 of the interleukin(IL)-2 receptor
    • Decreases IL-2 signalling at high-affinity receptor and increases signalling at intermediate-affinity receptor
    • Originally licensed for solid organ transplant rejection but withdrawn from market
      • But could it work in MS?
    • High yield process is a new way of processing the drug for a higher “cleaner” yield
    • Being evaluated for relapsing forms of MS
select trial design
SELECT Trial—Design
  • Randomised, double-blind, placebo-controlledphase IIb trial
    • Part of a registration trial package
  • Three study arms: daclizumabHYP 150 mg (n = 208) or 300 mg (n = 209), or placebo (n = 204)
    • Subcutaneous every 4 weeks for 52 weeks
  • Primary endpoint:
    • Annualized relapse rate
  • Secondary endpoints:
    • New gadolinium-enhancing brain MRI lesions
    • New/newly enlarging T2 hyperintenselesions
    • Proportion relapse-free patients
    • Quality of life
  • Tertiary endpoint:
    • Confirmed disability progression, measured by EDSS change
select trial key c linical and mri findings
SELECT Trial—Key Clinical and MRI Findings

Gold R, et al. Lancet. 2013;381:2167-2175.

select trial safety and tolerability
SELECT Trial—Safety and Tolerability
  • Well tolerated
    • Injection site reactions
  • Key adverse events of interest
    • Hypersensitivity reactions
      • Particularly skin reactions <1%
      • No Stevens-Johnson reactions
    • Serious infections, not opportunistic 1%–3%
    • Autoimmune hepatitis
      • Recognized by transaminitis

Gold R, et al. Lancet. 2013;381:2167-2175.

daclizumab hyp next steps
Daclizumab HYP—Next Steps
  • Phase III trial in relapsing-remitting MS (DECIDE)
    • Fully recruited and running
    • Interferon beta as active comparator
    • 2years
    • Results expected in 2016 or 2017
  • If phase III data show disability benefit relative to interferon, studies in progressive forms of MS should be considered
  • Future ideal candidate may be MS patients who are JC virus positive