CIVO® uses intratumoral microdosing to investigate novel cancer drugs
Cancer drugs are often effective in mouse models but not in the setting that matters most – patients with cancer. Meanwhile, biopharma companies generate far more drug candidates than they can evaluate in typical clinical trials.
Phase 0 Studies
Presage is pioneering a new approach to addressing these challenges. By coupling the CIVO platform with the FDA’s guidance on exploratory investigational new drug applications (exploratory IND), Presage has identified a path to rapidly evaluate multiple drug candidates, but without the costs and time associated with a traditional phase 1 clinical trial.
Such eIND studies—also known as Phase 0 trials—use minute amounts of drugs to assess their pharmacodynamics effects in patients. Unlike traditional phase 1 clinical trials that expose patients to far higher doses of investigational drugs, and therefore an increased risk of toxicity, intratumoral microdosing uses approximately 100-fold lower doses of drug candidates.