|
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 β-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) |
Fampridine
|
Acorda
|
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 |