A Phase 3, Randomized, Controlled, Double-Arm, Open-Label, Multi-center Study of VB-111 Combined With Bevacizumab vs. Bevacizumab Monotherapy in Patients With Recurrent Glioblastoma

• First or second progression of Glioblastoma;

• Measurable disease by RANO criteria at progression;

• Patients ≥18 years of age;

• Patient may have been operated for recurrence. If operated: residual and measurable disease after surgery is required;

• Surgery completed at least 28 days before randomization;

• An interval of at least 12 weeks between prior radiotherapy or at least 23 days from prior chemotherapy, 42 days from nitrosoureas and enrollment in this study;

• Adequate performance, i.e.Karnofsky Performance Score of at least 70%;

• Adequate renal, liver, and bone marrow function according to the following criteria:

• Absolute neutrophil count ≥1500 cells/ml,

• Platelets ≥ 100,000 cells/ml,

• Total bilirubin within upper limit of normal (ULN),

• Aspartate aminotransferase (AST) ≤ 2.0 X ULN,

• Serum creatinine level ≤ ULN or creatinine clearance ≥ 50 ml/min for patients with creatinine levels above normal limits (creatinine clearance calculated by the Cockcroft-Gault formula, see Appendix II),

• PT, PTT (in seconds) not to be prolonged beyond >20% of the upper limits of normal.