Processa Pharmaceuticals Completes Enrollment of 20th Patient for Formal Interim Analysis in Phase 2 NGC-Cap Breast Cancer Study

Core Viewpoint - Processa Pharmaceuticals has completed the enrollment and dosing of 20 patients for an interim analysis in its Phase 2 clinical study evaluating NGC-Cap, a combination treatment for advanced or metastatic breast cancer, with results expected in Q1 2026 [2][3]. Study Design and Patient Characteristics - The Phase 2 study is randomized and FDA-recommended, comparing NGC-Cap (Arm A) with capecitabine monotherapy (Mono-Cap, Arm C) in patients who have undergone at least one prior cancer treatment, with a median of two to three prior regimens [4]. - NGC-Cap consists of PCS6422 administered one day prior to capecitabine, followed by capecitabine at 150 mg twice daily for seven days on and seven days off, while the Mono-Cap arm consists of capecitabine at 1,000 mg/m² twice daily for 14 days followed by seven days off [5]. Mechanism of Action - PCS6422 is designed to enhance the metabolism of capecitabine by increasing the formation of cancer-killing metabolites (anabolites) and decreasing the formation of side effect-associated metabolites (catabolites) [6]. Interim Analysis Objectives - The interim analysis aims to compare safety and preliminary efficacy outcomes between NGC-Cap and Mono-Cap, with key objectives including evaluating early clinical benefit signals and guiding potential dose optimization and study design adjustments [7][10]. About NGC-Cap - NGC-Cap is Processa's lead oncology asset, aimed at improving the therapeutic index of capecitabine-based therapy by increasing systemic exposure to active metabolites while reducing toxic metabolites [8]. Company Overview - Processa Pharmaceuticals is focused on developing Next Generation Cancer drugs that modify existing FDA-approved therapies to improve safety and efficacy, utilizing a Regulatory Science Approach to enhance tolerability for cancer patients [9].