Processa Completes Enrollment of 20 Patients for NGC-Cap Clinical Study

Processa Pharmaceuticals reported that it completed the enrollment and dosing of the 20 patients required for the planned formal interim analysis in its ongoing Phase 2 clinical study evaluating NGC-Cap, Processa's proprietary combination treatment of PCS6422 and capecitabine, in patients with advanced or metastatic breast cancer. "This is an important milestone because it allows us to assess whether NGC-Cap can demonstrate a meaningful improvement over capecitabine monotherapy in both safety and efficacy for patients who have already undergone multiple prior cancer treatments.," said George Ng, CEO of Processa Pharmaceuticals. The randomized, FDA-recommended Phase 2 study is designed to compare NGC-Cap with standard-of-care capecitabine monotherapy in patients with advanced or metastatic breast cancer. Patients enrolled in the study were required to have received at least one prior cancer treatment, with a median of two to three prior treatment regimens across the enrolled population. The formal interim analysis will compare safety and preliminary efficacy outcomes between the NGC-Cap and Mono-Cap treatment arms and is expected to be completed in the first quarter of 2026. Key objectives of the interim analysis include: Evaluating the comparative safety and efficacy of NGC-Cap versus Mono-Cap; Determining whether a higher or lower dose of NGC-Cap should be added as a third study arm; Assessing whether the overall sample size of the Phase 2 study should be adjusted based on interim findings.