Cascade Prodrug’s is pursuing a strategy focused on bringing a novel hypoxia-activated chemotherapy into clinical development for treating solid tumors. The process involves candidate selection, IND-enabling studies and development of a clinical trial strategy that optimally positions liposomal CPD100 for broad therapeutic use.

Complete the profiling of CPD100-Li and CPD100-PEGLi and select a clinical candidate

  • Comparative pharmacology of liposomal formulations
  • Exploratory toxicology and ADME/PK studies in rats and dogs
  • Assess anti-tumor efficacy in dog spontaneous tumor model
  • Detailed comparative CMC assessment

Initiate IND-enabling studies within 12 months of funding

  • Pre-IND meeting with FDA
  • Develop GMP scale-up procedures and other CMC issues
  • GLP toxicity studies
  • File IND

Phase 1 clinical development strategy

  • All-comers trial open to patients with prostate, NSLC, pancreatic, cervical and head & neck cancers