Processa Pharma Provides Clinical Update On Ongoing Phase 2 Study Of NGC-Cap, Combination Treatment Of PCS6422 And Capecitabine, In Patients With Advanced Or Metastatic Breast Cancer

Preliminary Phase 2 data demonstrate PCS6422+Capecitabine increased cancer-killing metabolite exposure while maintaining comparable safety to monotherapy capecitabine

Company on track to conduct formal interim analysis in early 2026

VERO BEACH, Fla., Dec. 17, 2025 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (NASDAQ:PCSA), a clinical-stage biopharmaceutical company developing Next Generation Cancer (NGC) therapies, today provided a clinical update on its ongoing Phase 2 study of NGC-Cap, the combination treatment of PCS6422 and capecitabine, in patients with advanced or metastatic breast cancer.

Data from the first 16 of 19 patients enrolled indicate that NGC-Cap significantly increases exposure to capecitabine cancer-killing drug metabolites without increasing the severity of side effects compared to standard monotherapy capecitabine therapy (Mono-Cap). This profile suggests the potential for improved clinical efficacy while maintaining manageable safety, a key objective of Processa's NGC platform.

The full interim analysis from the first 20 patients enrolled in the study, which will include efficacy and safety data, is expected in early 2026.