This Was an Open-label, Single-arm Extension Study (CFTY720D2306E1) to a Double-blind, Randomized Multicenter, Placebo-controlled, Parallel-group Core Study (CFTY720D2306) in PPMS.

Exclusion Criteria

• •PPMS specific:
• •History of relapses/attacks
• •Progressive neurological disorder other than PPMS
• •Pure cerebellar syndrome or pure visual progressive syndrome or pure
• •cognitive progressive syndrome
• •Presence of spinal cord compression at screening MRI
• •Relevant history of vitamin B12 deficit
• •Evidence of syphilis or borreliosis at Screening
• •Cardiovascular conditions:
• •Myocardial infarction within the past 6 months or current unstable ischemic heart disease
• •History of angina pectoris due to coronary spasm or history of Raynaud's phenomenon
• •Severe cardiac failure or cardiac arrest
• •History of symptomatic bradycardia
• •Resting pulse \<55 bpm pre-dose
• •History of sick sinus syndrome or sino-atrial heart block
• •History or presence of second and third degree AV block or an increase QT interval (QTc\>440 ms)
• •Arrythmia requiring treatment with class III antiarrythmic drugs
• •History of positive tilt test from workout of vasovagal syncope
• •Hypertension, not controlled with medication
• •Pulmonary:
• •Severe respiratory disease or pulmonary fibrosis
• •TB
• •Abnormal X-ray, suggestive of active pulmonary disease
• •Abnormal PFT: \<70% of predicted for FEV1 and FVC; \<60% for DLCO
• •Patients receiving chronic (daily) therapies for asthma
• •Hepatic:
• •Known history of alcohol abuse, chronic liver or biliary disease
• •Total or conjugated Brb \>ULN, unless in context of Gilbert's syndrome
• •AP \>1.5xULN; ALT/AST \>2xULN; GGT\>3xULN
• •Other:
• •History of chronic disease of the immune system other than MS
• •Malignancy (other than successfully treated SCC or BCC)
• •Diabetes Mellitus
• •Macular Edema present at screening
• •HIV, Hepatitis C or B, other active infection
• •History of total lymphoid irradiation or bone marrow transplantation
• •Serum creatinine \>1.7 mg/dl
• •WBC \<3500 cells/mm3
• •Lymphocyte count \<800 cells/mm3
• •History of substance abuse or any other factor that may interfere with subject ability to cooperate and comply with the study procedures
• •Unable to undergo MRI scans
• •Participation in any therapeutical clinical research study in the 6 months prior to randomization
• •Pregnant or lactating women
• •Drugs requiring wash-out period:
• •3 months:
• •* Systemic corticosteroids or ACTH
• •* INF-beta
• •6 months:
• •* Immunosuppressive medication
• •* Immunoglobulins
• •* Monoclonal antibodies
• •Drugs that exclude participation in the study:
• •Cladribine
• •Cyclophosphamide
• •Mitoxantrone (except: patients who received a cumulative dose of no more than 60mg/m2 more than 5 years ago could enter the study)