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

Core Insights - Processa Pharmaceuticals is advancing its Phase 2 study of NGC-Cap, a combination of PCS6422 and capecitabine, showing promising preliminary results in increasing cancer-killing metabolite exposure while maintaining safety compared to standard capecitabine therapy [1][2][3]. Clinical Update - The ongoing Phase 2 study targets patients with advanced or metastatic breast cancer, with preliminary data from the first 16 of 19 enrolled patients indicating significant increases in exposure to capecitabine metabolites without heightened side effects [2][3][4]. - The full interim analysis, expected in early 2026, will provide comprehensive efficacy and safety data from the first 20 patients [4][11]. Safety and Efficacy Observations - Initial findings show that patients receiving NGC-Cap (150 mg twice daily) experienced higher exposure to active cancer-killing metabolites compared to those on standard Mono-Cap (1,000 mg/m² twice daily) [6]. - Although a greater proportion of patients on NGC-Cap reported side effects related to the active metabolites, the severity of these side effects was comparable to those on Mono-Cap, indicating manageable toxicity levels [7][9]. Metabolite Analysis - Patients on NGC-Cap exhibited up to ten times lower exposure to FBAL, a catabolite associated with side effects like hand-foot syndrome (HFS), compared to those on Mono-Cap [8]. - The incidence of HFS was similar between treatment groups, but symptoms were milder (Grade 1) in the NGC-Cap group compared to more severe symptoms (up to Grade 2) in the Mono-Cap group [9][10]. Strategic Importance - The NGC-Cap program is viewed as a key value driver for Processa, with the potential to improve therapeutic outcomes for patients with advanced or metastatic breast cancer by balancing efficacy and tolerability [5][12].