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Posted: Mon Nov 01, 2004 7:08 pm Post subject: Some info about an upcoming phase 2 trial of daclizumab
This from Protein Design Lab's quarterly results announcement today,
"Preparatory work for a PDL (Protein Design Lab) study of daclizumab in multiple sclerosis (MS) continues, and the company currently plans to initiate a Phase II study in MS in the first quarter of 2005."
Agent: Zenapax® (daclizumab) COMPLETED
Purpose of study: To control relapses and determine impact on immune function
Possible mechanism: Inhibits IL-2-mediated activation of lymphocytes
Study description: Open label, crossover
Dose/route: 1 mg/kg/mo iv
Outcome parameters: Frequency of relapse, scoring technique, MRI
Type of MS: RR, SP
Number of Subjects: 10
Start date: February 2000
Observation period: 15.5 months
Investigators: R. Martin
Sites: NIH, Bethesda, MD
Results/Publications: Tolerated well, safe; 75% reduction in inflammatory activity by MRI in
majority of pts; results suggest that T cells under long-term CD25 blockage adjust IL-2R signaling
efficiency, enhancing responsiveness to IL-4, IL-7, IL-9 and IL-15 (Abstract #320, FOCIS 2nd
Annual Meeting 2002; Abstract #S55.002, AAN 2003; Proceedings of the National Academy of
Sciences U S A 2004;101(23):8705-
Funding: NIH
Last update: Summer/Fall 2004
Agent: Zenapax® (daclizumab)
Purpose of study: To evaluate safety and impact on disease progression
Possible mechanism: Inhibits IL-2-mediated activation of lymphocytes
Study description: Open label
Dose/route: 1 mg/kg at entry, 2 wks, then monthly iv
Outcome parameters: Safety, clinical status
Type of MS: RR, SP
Number of Subjects: 8
Start date: Not available
Observation period: 12 months
Investigators: J. Rose
Sites: University of Utah School of Medicine, Salt Lake City
Results/Publications: 16 pts treated for 6-22 mos; discontinued therapy (1); sustained clinical
improvement (7); stabilized (12); T2 improvement (5); absence of new enhancing lesions (11); side
effects - nausea, paraesthesias, rash leukopenia. (Abstract #P06.101, AAN 2003; Abstract #S12.002,
AAN 2004)
Funding: VA Salt Lake City Health Care System, West Institute
Last update: Summer/Fall 2004
They're enrolling here for the Phase 2 trial of daclizumab. I was kind of surprised that they want participants who are on interfuron since it's a monoclonal antibody. I think in Phase 1 they administered it by IV. In this one it's a subcutaneous injection every other week.
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