Safety Study of BLZ-100 in Adult Subjects With Glioma Undergoing Surgery

Exclusion Criteria

• •1. Evidence of metastatic disease.
• •2. Female who is lactating/breastfeeding
• •3. Female with a positive pregnancy test or who is planning to become pregnant during the duration of the study.
• •4. Karnofsky Performance Status of \<60%.
• •5. Any of the following laboratory abnormalities at Screening:
• •1. Neutrophil count \<1.5 x 10\^9/L
• •2. Platelets \<75 x 10\^9/L
• •3. Hemoglobin \<10 g/dL (may be determined following transfusion)
• •4. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 3x upper limit of normal (ULN)
• •5. Total bilirubin \>1.5x upper limit of reference range (unless Gilbert's syndrome or extrahepatic source as denoted by increased indirect bilirubin fraction)
• •6. International Normalized Ratio (INR) \>1.5
• •7. Creatinine \>1.5x ULN
• •6. Positive serology for human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV).
• •7. QTc prolongation \>450 msec
• •8. History of hypersensitivity or allergic reactions requiring corticosteroids, epinephrine and/or hospitalization.
• •9. Uncontrolled asthma or asthma requiring oral corticosteroids.
• •10. Known or suspected sensitivity to MRI contrast agents or excipients in the study drug product.
• •11. Known or suspected sensitivity to Indocyanine green (ICG).
• •12. Unstable angina, myocardial infarction, known or suspected transient ischemic events or stroke within 24 weeks of start of Screening.
• •13. Uncontrolled hypertension.
• •14. Receipt of photosensitizing drugs within 30 days of Screening.
• •15. Any ongoing medications which might generate fluorescence or according to label, might generate a photochemical reaction. These include haematoporphyrin derivatives and purified fractions; Photofrin®; and the precursors of protoporphyrin IX (5-Aminolevulinic acid) used in Gliolan or Hexvix.
• •16. Received an investigational drug or device within 30 days of enrollment.
• •17. Prior treatment with BLZ-100.
• •18. Any concurrent condition, including psychological and social situations, which, in the opinion of the investigator, would impact adversely on the subject or the interpretation of the study data.
• •\-