Efficacy, Safety, and Tolerability of Plovamer Acetate (Pathway 1)
Efficacy, Safety, and Tolerability of Plovamer Acetate (Pathway 1)
This is a Phase 2, randomized, rater-blinded, 5-arm, parallel-group trial that will test 4
 doses of plovamer acetate against the active comparator Copaxone in subjects with Relapsing
 Remitting Multiple Sclerosis (RRMS). The trial will be conducted on an outpatient basis for
 minimum treatment duration of 40 weeks.
Inclusion Criteria:

 -  Male or female, between the ages of 18 and 60 years

 -  Subject is able to learn and self-administer subcutaneous injections (a care-giver may
 be trained to inject the subject)

 -  Subjects must have a current diagnosis of Relapsing Remitting Multiple Sclerosis
 (RRMS) (according to the 2010 McDonald MS diagnostic criteria)

 -  Other protocol defined inclusion criteria could apply

 Exclusion Criteria:

 -  Any multiple sclerosis categorized as primary progressive, secondary progressive or
 progressive relapsing

 -  Allergy to mannitol, plovamer acetate, Copaxone (glatiramer acetate), Gd contrast for
 MRI

 -  Any requirement for continuous systemic glucocorticoid administration during the trial
 period. (Note: Treatment with interferons such as Avonex®, Rebif®, or Betaseron® will
 be allowed until the baseline visit, as no wash-out period is needed)

 -  Contraindication to Copaxone use

 -  Other protocol defined exclusion criteria could apply