Processa Pharma Reports Successful Completion Of Phase 1b Safety Evaluation Of NGC-Cap

(RTTNews) - Processa Pharmaceuticals, Inc. (PCSA), a clinical-stage pharmaceutical company, announced the successful completion of the safety tolerability evaluation in its Phase 1b trial of Next Generation Capecitabine. Shares of the nano-cap company surged over 140% on Thursday morning.

From the Phase 1b data, two dosage regimens have been selected for the Phase 2 trial. The Phase 2 trial will be in advanced or metastatic breast cancer given FDA's agreement that the Phase 1b data can be used to support the design of the Phase 2 trial in breast cancer.

NGC-Cap is PCS6422 administered in combination with capecitabine, a precursor of the cancer drug 5-FU. PCS6422 is administered as a single dose 12-24 hours prior to receiving seven days of capecitabine followed by seven drug-free days.

"Processa is very grateful to the patients and their physicians who participated in this trial and have been instrumental in our reaching these impactful findings. We are encouraged that NGC-Cap in the Phase 1b trial was tolerated better than or similar to the existing FDA-approved capecitabine even though the exposure to NGC-Cap's 5-FU cancer-treating metabolite was 2-10 times that of capecitabine," said David Young, PharmD, Ph.D., President of Research and Development at Processa. "This greater exposure suggests that NGC-Cap can distribute more 5-FU to the cancer cells, potentially forming more cancer-killing metabolites that, in our small number of patients, has shown to improve the cancer-killing effect of NGC-Cap over capecitabine."