Clinical Trials

Inclusion Criteria

• Previously enrolled and treated for at least 9 months in Study NEOD001-001
• Ability to understand and willingness to sign an informed consent form prior to initiation of any study procedures
• Has adequate bone marrow reserve, and hepatic and renal function, as demonstrated by
  • Absolute neutrophil count (ANC) ≥1.0 ×109/L
  • Platelet count ≥75 × 109/L
  • Hemoglobin ≥9 g/dL
  • Total bilirubin ≤2 times the upper limit of normal (× ULN)
  • Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) ≤3 × ULN
  • Estimated glomerular filtration rate ≥30 mL/minute
• Seated systolic blood pressure 90 to 180 mmHg
• ECOG Performance Status 0 to 2
• Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 28 days prior to the first administration of study drug and agree to use highly effective physician-approved contraception from 30 days prior to the first study drug administration to 90 days following the last study drug administration
• Male subjects must be surgically sterile or must agree to use highly effective physician-approved contraception from 30 days prior to the first study drug administration to 90 days following the last study drug administration

Exclusion Criteria

• Any new medical contraindication or clinically significant abnormality on physical, neurological, laboratory, vital signs, or electrocardiogram (ECG) examination such as atrial fibrillation
  • With the exception of subjects for whom the ventricular rate is controlled
• History of Grade ≥3 infusion-associated adverse events or hypersensitivities to NEOD001 or any of its excipients
• Treatment with any anticancer therapy (standard or investigational) within the 14 days prior to the first dose of study drug
  • 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
• 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
• Uncontrolled symptomatic orthostatic hypotension
• 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
• Uncontrolled infection
• 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
• Uncontrolled human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection
• Women who are lactating