STRATEGIC GOALS
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