PROCESSA PHARMACEUTICALS, INC. Processa Pharmaceuticals, Inc. provides an interim analysis from its ongoing Phase 1B trial of Next Generation Capecitabine (NGC-Cap) in patients with gastrointestinal cancer, which identifies a personalized treatment approach that may yield improved safety and treatment efficacy. NGC-Cap combines the administration of PCS6422, Processa's irreversible dihydropyrimidine dehydrogenase (DPD) enzyme inhibitor, with low doses of the commonly used chemotherapy capecitabine, which is metabolized to 5-fluorouracil (5-FU) in the body. DPD promotes the further metabolism of 5-FU tofluor-beta-alanine (FBAL), a metabolite that leads to dose-limiting chemotherapy side effects.
Processa has found that regularly measuring the concentrations of DPD, as expressed by the metabolite FBAL, may provide a method to better understand how each patient responds to different NGC-Cap dosage regimens. This insight potentially allows physicians to develop and administer patient-specific treatment protocols of NGC-Cap for each patient to inhibit the development of side effects and promote broader drug efficacy, patient safety, and tolerability. The first three of five cohorts in the Phase 1B trial have completed enrollment and the initial safety evaluation.
The fourth cohort has completed enrollment, and the safety evaluation is ongoing. Enrollment in the last cohort is expected to be completed in 4Q23, leading to an assessment of the safety profile and potentially preliminary efficacy of NGC-Capecitabine in totality across all cohorts by year-end. This cumulative view of the safety profile will allow Processa to determine the appropriate dose regimens to be used in its planned Phase 2 study in patients with colorectal cancer to determine the Optimal Dose Regimen, as mandated by the FDA's new Project Optimus Initiative.
About Next Generation Capecitabine(NGC-Cap) NGC-Cap combines the Administration of PCS6422, the Company's irreversible dihydropyridine dehydrogenase (D PD). PCS6422 is an uracil analog that irreversibly inhibits dihydropyrimidine dehyd hydrogenase (DPD). PCS6422 isither toxic nor active as a single agent in animals at comparable dose levels.
However, when administered in combination with Capecitabine or 5-FU, PCS6422 decreases the metabolism of 5-FU to the catabolites that only cause side effects.
