Open-label Extension Study of NEOD001 in Subjects With Light Chain (AL) Amyloidosis

Exclusion Criteria

• •1. Any new medical contraindication or clinically significant abnormality on physical, neurological, laboratory, vital signs, or electrocardiogram (ECG) examination (e.g., atrial fibrillation; with the exception of subjects for whom the ventricular rate is controlled) that precludes continued or initiation of treatment with NEOD001 or participation in the study
• •2. History of Grade ≥3 infusion-associated adverse events (AEs) or hypersensitivities to NEOD001 or any of its excipients
• •3. Treatment with any anticancer therapy (standard or investigational) within the 14 days prior to the first dose of study drug. In addition, subjects must have fully recovered (i.e., National Cancer Institute Common Terminology Criteria for Adverse Events \[CTCAE\] Grade 1 \[exception: subjects with prior bortezomib may have CTCAE Grade 2 neuropathy\]) from the clinically significant toxic effects of that treatment
• •4. Received any of the following within the specified time frame prior to the first administration of study drug:
• •* Hematopoietic growth factors, transfusions of blood or blood products within 1 week
• •* Major surgery within 2 weeks
• •* Radiotherapy within 2 weeks
• •* Transplant within 8 weeks
• •* Investigational drug other than NEOD001 within 4 weeks
• •* Another experimental anti-amyloid therapy other than NEOD001 within 2 years
• •5. Uncontrolled symptomatic orthostatic hypotension
• •6. Myocardial infarction, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia, within 6 months prior to the first dose of study drug
• •7. Uncontrolled infection
• •8. Secondary malignancy, with the exception of:
• •* Adequately treated basal cell carcinoma, squamous cell carcinoma, or in situ cervical cancer
• •* Adequately treated stage I cancer from which the subject is currently in remission
• •* Any other cancer from which the subject has been disease-free for ≥3 years
• •9. Uncontrolled human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection
• •10. Women who are lactating