Multiple Sclerosis

Monoclonal Drug Treaments in Development

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Product Manufacturer Description Comments Status Phase 3 Clinical Trials
Rituximab Genentech/Biogen Idec anti-CD20, induces B-cell depletion; delivered via IV for B-cell non-Hodgkin's lymphoma in 100 mg or 500 mg single-use vials; 1000 mg IV on days 1 and 15 for Hauser et al trial for RRMS Promising for RRMS (HERMES Phase 2); PPMS Phase 3 results due H1:08 (has 439 patients enrolled, primary endpoint is time to progression over 96 weeks) Phase 2/3 1. OLYMPUS - A Study to Evaluate the Safety and Efficacy of Rituximab in Adults With Primary Progressive Multiple Sclerosis, 2004-2008 (NCT00087529)  (Primary endpoint is time-to-disease progression measured by EDSS at 96 weeks)   
2nd generation anti-CD20 Legal issues with Biogen may be holding things up Phase 3 none found for M.S.  
Campath (Alemtuzamab) Genzyme/Bayer anti-CD52, induces rapid and prolonged depletion of peripheral T-cells Needs to prove monthly monitoring can protect against ITP (immune thrombocytopenia purpura)
Phase 3 
1.  CARE-MS I - Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis, Study One - no previous treatment,  2007-2011 (NCT00530348)  2.  CARE MS II - Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis, Study Two - previous DMD treatment, 2007-2011 (NCT00548405)   
ABT-874 Abbot/CAT neutralizes interleukin-12   Phase 2 1.  Safety and Effectiveness of Two Doses of ABT-874 as Compared to Placebo in Subjects With Multiple Sclerosis (MS), 2004-2006 (NCT00086671) Phase 2 completed  
MLN1202 Millennium blocks CCR2 chemokine receptors and prevents infiltration of immunce cells into inflammatory sites     none found for M.S.  
Zenapax (daclizumab) Protein Design Labs/Biogen Idec anti-CD25   Phase 2 1. Zenapax (Daclizumab) to Treat Relapsing Remitting Multiple Sclerosis, Phase 2 (NCT00071838)  2.  Zenapax to Treat Multiple Sclerosis, Phase 2 (NCT00001934)  3.  Safety and Efficacy Study of Daclizumab HYP to Treat Relapsing-Remitting Multiple Sclerosis, Phase 2 (NCT00390221)  
Centocor/Medarex anti-IL-12   Phase 2 1.  A Safety and Efficacy Study of CNTO1275 in Patients With Multiple Sclerosis, 2004-2006 (NCT00207727) Phase 2 completed

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