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Phase 0 Trials
By coupling the platform with the FDA s guidance on exploratory IND, Company has identified a path to rapidly evaluate multiple drug candidates, but without the costs and time associated with a traditional phase 1 clinical trial.
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.
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