Randomized Phase 2, Dose-finding Efficacy, Safety Study of ANF-RHO™ Versus Neulasta® in Chemotherapy-Induced Neutropenia

Exclusion Criteria

• •1. Known hypersensitivity to E.coli derived products or polyethylene glycol
• •2. No other malignancy except carcinoma in situ and basal-cell and squamous cell carcinoma of the skin, unless the other malignancy was treated ≥ 5 years ago with curative intent
• •3. Evidence of myelodysplasia, aplastic anemia, myelofibrosis, rheumatoid arthritis, systemic lupus erythematosus, or sickle cell disease
• •4. Clinical diagnosis or history of chronic infection such as hepatitis B virus (HBV), hepatitis C virus (HCV) or Human immunodeficiency virus (HIV) or history of tuberculosis
• •5. Previous exposure to filgrastim, perfilgrastim or lipegfilgrastim within 30 days before randomization
• •6. Treatment with systemically active antibiotics within 72 hours before chemotherapy
• •7. Chronic use of oral corticosteroids
• •8. Participation in a pharmacological clinical trial within 30 days before randomization
• •9. Clinical diagnosis of drug abuse or substance abuse within 30 days prior to screening
• •10. Documented alcohol abuse within 30 days prior to screening
• •11. Unwilling and/or not capable of ensuring compliance with the provisions of the study protocol
• •12. Pregnant or breastfeeding women where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum HCG laboratory test
• •13. Other serious medical condition that would prevent individual from receiving protocol treatment