Study of the Safety and Efficacy of MLN1202 in Patients in Multiple Sclerosis
Study of the Safety and Efficacy of MLN1202 in Patients in Multiple Sclerosis
This was a phase 2a study of MLN1202 to determine safety, tolerability and initial efficacy
 in patients with relapsing-remitting multiple sclerosis (RRMS). It was conducted in 2 dose
 cohorts enrolling a total of 50 patients. Efficacy was assessed by comparing the numbers of
 new gadolinium-enhancing brain lesions during the screening and treatment periods.
Inclusion Criteria:

 Each patient was to have met all of the following inclusion criteria to be enrolled in the
 study:

 -  18 years of age or older

 -  Diagnosis of relapsing-remitting multiple sclerosis (RRMS)

 -  An Expanded Disability Status Score (EDCC) of 0 to 5.5, inclusive

 -  Be willing and able to comply with the protocol for the duration of the study period

 -  Be willing to use adequate "double-barrier" contraceptive methods for the duration of
 the study period

 -  If female, must be neither pregnant or breast-feeding

 -  Written informed consent

 -  To be enrolled in the treatment phase of the study each patient must have a total of
 at least 2 new gadolinium-diethylenetriamine pentaacetic acid (Gd)-enhancing lesions
 seen over the series of 3 pretreatment magnetic resonance imaging (MRI)s.

 Exclusion Criteria:

 Patients meeting any of the following exclusion criteria were not to be enrolled in the
 study:

 -  Diagnosis of primary progressive multiple sclerosis (PPMS) or secondary progressive
 multiple sclerosis (SPMS)

 -  Received any investigational drug or experimental procedure within 3 months prior to
 study day 0

 -  If the patient has received disease-modifying treatments they must be discontinued
 prior to study day 0 as follows:

 1. Cyclophosphamide or mitoxantrone- 6 months prior

 2. Interferons, glatiramer acetate and azathioprine- 12 weeks prior

 3. Methotrexate, IV immunoglobulin, cyclosporin, plasma exchange or corticosteroids-
 8 weeks prior

 -  Never have been exposed to Tysabri® (natalizumab)or any other VLA-4 (α4β1)antagonist

 -  Have an active infection or be considered to be at high risk for developing an
 infection

 -  Have a history of hepatitis B, C or human immunodeficiency virus (HIV)

 -  Have a chest X-ray within 6 months of study day 0 with clinically significant findings
 or abnormalities

 -  Have inadequate renal or hepatic function

 -  Have a known history of cancer, except for distant history (>10 years) of carcinoma in
 situ of the cervix or adequately treated basal cell carcinoma of the skin

 -  Received any live, attenuated vaccinations within 30 days prior to study day 0

 -  Have a history of illicit drug or alcohol abuse within 5 years of study day 0

 -  Have a history of hypersensitivity to prior monoclonal antibody (mAb) treatment

 -  Have a history of allergy or sensitivity to Gd

 -  Have a history that would preclude serial MRI scans