Wednesday, December 17, 2025

Processa Pharmaceuticals Clinical Update on Phase 2 Study in Metastatic Breast Cancer



Processa Pharmaceuticals (Nasdaq: PCSA) provided a Phase 2 clinical update for NGC-Cap (PCS6422 + capecitabine) on Dec 17, 2025. Preliminary analysis of the first 16 of 19 randomized patients indicates NGC-Cap increases exposure to capecitabine's active, cancer-killing metabolites while maintaining comparable severity of side effects versus standard capecitabine monotherapy.

Key measured facts: NGC-Cap dosing was 150 mg BID vs Mono-Cap 1,000 mg/m² BID, and exposure to the catabolite FBAL was reduced by up to 10-fold. A formal interim analysis of the first 20 patients is expected in early 2026 with final enrollment targeted by end of Q1 2026.

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