Dose-ranging Study of PRX-102 in Adult Fabry Disease Patients

Inclusion Criteria: * Symptomatic adult Fabry patients (≥18 yrs) * Males: plasma and/or leucocyte alpha galactosidase activity (by activity assay) less than lower limit of normal (LLN in plasma=3.2 nmol/hr/ml, LLN in leucocytes=32 nmol/hr/mg/protein) * Females: historical genetic test results consistent with Fabry mutations * Globotriaosylceramide (Gb3) concentration in urine \> 1.5 times upper normal limit * Patients who have never received enzyme replacement therapy (ERT) in the past, or patients who have not received ERT in the past 6 months and have a negative anti alpha galactosidase antibody test * eGFR ≥ 60 mL/min/1.73m2 * The patient signs informed consent * Female patients and male patients whose co-partners are of child-bearing potential agree to use a medically acceptable method of contraception, not including the rhythm method Exclusion Criteria: * Participation in any trial of an investigational drug within 30 days prior to study screening * Chronic kidney disease stages 3-5 (CKD 3-5) (Appendix 7) * History of dialysis or renal transplantation * Angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) therapy initiated or dose changed in the 4 weeks prior to screening * Severe myocardial fibrosis by MRI (≥2 late-enhancement \[LE\] positive left ventricular segments) (Weidemann et al. 2009) * History of clinical stroke * Pregnant or nursing * Presence of HIV and/or HBsAg and/or Hepatitis C infections * Known allergies to ERT * Known allergy to Gadolinium based contrast agents * Presence of any medical, emotional, behavioral or psychological condition that, in the judgment of the Investigator and/or Medical Director, would interfere with the patient's compliance with the requirements of the study