VERO BEACH, Fla. — January 5, 2026 — Leads & Copy — Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) announced it has completed enrollment and dosing of 20 patients for the planned interim analysis in its Phase 2 clinical study. The study evaluates NGC-Cap, Processa’s proprietary combination treatment of PCS6422 and capecitabine, in patients with advanced or metastatic breast cancer.
The formal interim analysis is expected to be completed in the first quarter of 2026.
According to George Ng, Chief Executive Officer of Processa Pharmaceuticals, the milestone allows the company 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.
The randomized, FDA-recommended Phase 2 study is designed to compare NGC-Cap (Arm A) with standard-of-care capecitabine monotherapy (Mono-Cap, Arm C) 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.
NGC-Cap consists of a single dose of PCS6422 administered one day prior to capecitabine, followed by capecitabine at 150 mg twice daily for seven days on treatment and seven days off. The Mono-Cap arm consists of capecitabine administered at 1,000 mg/m² twice daily for 14 days followed by seven days off treatment.
PCS6422 is designed to re-engineer capecitabine metabolism by increasing the formation of cancer-killing metabolites (anabolites) while decreasing the formation of metabolites associated primarily with side effects (catabolites).
The formal interim analysis will compare safety and preliminary efficacy outcomes between the NGC-Cap and Mono-Cap treatment arms. 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
According to Dr. David Young, President of Research and Development at Processa, the interim analysis is designed to evaluate early signals of clinical benefit and to guide potential optimization of dose selection and overall study design. He stated that these data will be critical as the company determines the most appropriate path forward to maximize the therapeutic potential of NGC-Cap.
NGC-Cap is Processa’s lead oncology asset and a key component of its Next Generation Cancer (NGC) platform. When administered, NGC-Cap is designed to increase systemic exposure to active cancer-killing anabolite metabolites while reducing formation of toxic catabolite metabolites, potentially improving the therapeutic index of Capecitabine-based therapy.
Processa is focused on developing Next Generation Cancer (NGC) drugs with improved safety and efficacy. Processa’s NGC drugs are modifications of existing FDA-approved oncology therapies resulting in an alteration of the metabolism and/or distribution of these drugs while maintaining the existing mechanisms of killing the cancer cells.
Patrick Lin
(925) 683-3218
plin@processapharma.com
Source: Processa Pharmaceuticals, Inc.
