Processa Advances NGC-Cap in Phase 2 Breast Cancer Study for Improved Chemotherapy

Processa Pharmaceuticals (Nasdaq: PCSA) has commenced dosing in its Phase 2 clinical trial evaluating NGC-Cap, a next-generation chemotherapy drug for advanced or metastatic breast cancer. The trial will involve 60 to 90 patients and compare two different doses of NGC-Cap to capecitabine, an FDA-approved chemotherapy. This study is part of the FDA’s Project Optimus Initiative, which focuses on determining optimal drug dosages, and it will also explore the potential for personalized NGC-Cap therapy. Processa expects interim results from this trial by mid-2025, building on promising data from its earlier Phase 1b study.

This global, multicenter trial has already secured institutional review board approval at three locations, with recruitment underway. The company plans to expand the trial to about 30 sites worldwide. The adaptive study design will allow Processa to adjust the trial as needed based on early data, optimizing the safety and efficacy profile of NGC-Cap in comparison to monotherapy capecitabine.

Breast cancer remains a major global health concern, with over 2 million cases diagnosed and more than 665,000 deaths in 2022 alone. Metastatic breast cancer, in particular, has a five-year survival rate of just 30%, highlighting the critical need for more effective treatment options. Processa aims to address this unmet need by developing a more tolerable and effective chemotherapeutic option with NGC-Cap, potentially offering new hope for patients battling advanced forms of breast cancer.