Multiple Sclerosis

Oral Drug Treaments in Development

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Product Manufacturer Description Comments Status Clinical Trials
Teriflunomide  Sanofi-Aventis Immunomodulator     Phase 3 1.  Phase III Study With Teriflunomide Versus Placebo in Patients With First Clinical Symptom of Multiple Sclerosis, 2008-? (NCT00622700)  2.  Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosis (TEMSO), 2004-? (NCT00134563) 
Cladribine Merck Serono/Teva  Purine analogue, apoptosis inducer Efficacy expected based on IV data from JNJ several years ago
Phase 3; Will likely report Phase 3 data in early 2009 1.  CLARITY - Safety and Efficacy of Oral Cladribine in Subjects With Relapsing-Remitting MS, 2005-2008 (NCT00213135) -placebo controlled
FTY720 (fingolimod; sphinosine-1-phosphate receptor modulator) Novartis

Once daily oral Immunosuppressant (T-cell trafficking), blocks exit of lymphocytes from secondary lymphoid organs Concern rising over associations with bradycardia, macular edema, and rare cases of posterior reversible encephalopathy Phase 3; data expected in 2009 1.  FREEDOMS II (ex-US) - Efficacy and Safety of Fingolimod (FTY720) in Patients With Relapsing-Remitting Multiple Sclerosis, 2006-2010 (NCT00355134)  2.  FREEDOMS I (US) - Efficacy and Safety of Fingolimod in Patients With Relapsing-Remitting Multiple Sclerosis, 2006-2009 (NCT00289978)   3.  TRANSFORMS (vs. Avonex)- Efficacy and Safety of Fingolimod in Patients With Relapsing-Remitting Multiple Sclerosis With Optional Extension Phase, 2006-2008 (NCT00340834)
Temsirolimus (CCI-779) Wyeth  Cell cycle inhibitor, blocks the proliferation of immune T cells activated interleukin 2    Phase 2 1.  Study Evaluating CCI-779 in Relapsing Multiple Sclerosis, 2003-completed (NCT00228397) Phase 2 completed
Laquinimod Teva & Active Biotech Immunomodulator    Phase 3 1.  Safety and Efficacy of Orally Administered Laquinimod for Treatment of Relapsing Remitting Multiple Sclerosis (RRMS), 2007-2011(NCT00509145)  2.  BRAVO - Laquinimod Double Blind Placebo Controlled Study in RRMS Patients With a Rater Blinded Reference Arm of Interferon ╬▓-1a (Avonex┬«), 2008-2010 (NCT00605215)
Copaxone (oral) Teva  Glatiramer acetate (polypeptides)   Phase 3 none found
MBP8298 Lilly/BioMS Technology Corp Intravenous synthetic peptide that mimics human myelin basic protein (MBP) For SPMS first, RRMS second Phase 3 for SPMS and Phase II for RRMS 1.  MAESTRO-03 - Efficacy and Safety of MBP8298 in Subjects With Secondary Progressive Multiple Sclerosis, 2007-2010 (NCT00468611)

4-aminopyrmidine Likely approvable, appropriate for 5-20% of patients, possible risk of seizure

Phase 3, data in Q2:08 1.  Study of Oral Fampridine-SR in Multiple Sclerosis, 2005-2006 (NCT00127530)  Phase 3 completed.  2.  Study of Fampridine-SR Tablets in Multiple Sclerosis Patients, 2007-? (NCT00483652)   Phase 3 completed.
BG00012 Biogen Idec (acquired from Fumapharm AG) Hoped for interferon-like activity with convenient oral dosing Nausea and flushing side effects seen in phase 2, placebo-controlled trials are having trouble with enrollment Phase 3 1. DEFINE - Efficacy and Safety of BG00012 in Relapsing-Remitting Multiple Sclerosis, 2007-2010 (NCT00420212)  2.  CONFIRM - Efficacy and Safety Study of BG00012 With Active Reference in Relapsing-Remitting Multiple Sclerosis, 2007-2010 (NCT00451451) versus placebo and copaxone

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