Processa Pharmaceuticals has commenced its Phase II clinical trial of Next Generation Capecitabine (NGC-Cap) by dosing the first patient. This trial aims to evaluate NGC-Cap as a treatment for patients with advanced or metastatic breast cancer.
Trial Design and Objectives
The Phase II trial is a global, multi-center, open-label, adaptive study designed to enroll between 60 and 90 patients. It will compare two different doses of NGC-Cap to the FDA-approved single-agent capecitabine. The primary objectives are to assess the safety and efficacy of NGC-Cap, determine optimal dosing regimens in accordance with the FDA's Project Optimus Initiative, and explore the potential for personalized therapy.
David Young, PharmD, Ph.D., President of Research and Development at Processa, stated, “Dosing the first patient in this Phase II trial is a significant step in the development of NGC-Cap as a more effective and better-tolerated treatment than widely used capecitabine and 5-FU.” The company anticipates announcing interim analysis results from this Phase II trial in mid-2025.
NGC-Cap: Mechanism of Action
NGC-Cap is a combination of PCS6422, a dihydropyrimidine dehydrogenase (DPD) enzyme inhibitor, and low-dose capecitabine, a prodrug of 5-fluorouracil (5-FU). Capecitabine is frequently used in chemotherapy for solid tumors. By inhibiting the DPD enzyme, PCS6422 reduces the conversion of 5-FU into harmful byproducts that cause side effects, while simultaneously enhancing its cancer-killing effects.
Trial Sites and Recruitment
Currently, three clinical sites, some with multiple locations, have received approval and are actively recruiting patients. Processa plans to activate approximately 30 sites globally for this trial.
Breast Cancer Statistics
Breast cancer is a significant global health concern. In 2022, over 2 million cases were diagnosed, resulting in more than 665,000 deaths worldwide. The five-year survival rate for metastatic breast cancer is approximately 30%.
