FDA clears IND for Processa's NGC-Cap Phase 2 trial in breast cancer

Processa Pharmaceuticals, Inc.

FDA cleared IND for NGC-Cap Phase 2 trial in advanced/metastatic breast cancer.
Phase 2 trial enrollment expected to begin in Q3 2024.
Initial data from the Phase 2 trial expected mid-2025.
Phase 1b showed NGC-Cap provides 5-10x more 5-FU exposure and better safety than capecitabine alone.
Trial is global, open-label, adaptive design with 60-90 patients; compares two doses of NGC-Cap to capecitabine.

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