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Processa Pharmaceuticals Announces Next Generation Capecitabine (Combination of PCS6422 and Capecitabine) Inhibits DPD in Phase 1b Interim Analysis
Next Generation Capecitabine inhibited DPD activity 24-48 hours after PCS6422 administration with 10% of 5-FU metabolized to FBAL compared to 80% reported for
About this update from Processa Pharmaceuticals, Inc.
[{"type":"text","content":"Next Generation Capecitabine inhibited DPD activity 24-48 hours after PCS6422 administration with 10% of 5-FU metabolized to FBAL compared to 80% reported for FDA approved capecitabine.24-48 hours after PCS6422 administration, 5-FU potency based on systemic exposure per mg of capecitabine was at least 50 x greater than reported for FDA approved capecitabine.The improved metabolism profile and increased potency did not exist 7 days after PCS6422 administration.The timeline of DPD inhibition and de novo formation will be further evaluated in the existing study in order to identify PCS6422 regimens which may inhibit DPD throughout capecitabine dosing. HANOVER, MD, Nov. 04, 2021 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (NASDAQ: PCSA), (“Processa” or the “Company”), a clinical-stage biopharmaceutical company developing products to improve the survival and/or quality of life for patients who have unmet medical need conditions, announced today that the Company’s Next Generation Capecitabine dosage regimen (a combination of PCS6422 administered with capecitabine) successfully inhibited dihydropyrimidine dehydrogenase (DPD), altering the metabolism of 5-fluoruracil (5-FU) at least during the first 24-48 hours after PCS6422 administration but not throughout the 7 days of capecitabine dosing. If Next Generation Capecitabine inhibits the metabolism of 5-FU throughout capecitabine dosing, the combination product could be a more potent and safer cancer treatment than current chemotherapy drugs including FDA approved capecitabine, opening a multi-billion-dollar cancer chemotherapy market across multiple types of cancer. From the pharmacokinetic analyses of capecitabine, 5-FU, and their metabolites on days 1 and 7 of capecitabine treatment, the one-day dosing of PCS6422 irreversibly inhibited dihydropyrimidine dehydrogenase (DPD) on day 1 of capecitabine dosing in the first 2 Cohorts of the Phase 1b trial resulting in: 1) less than 10% of 5-FU being metabolized to FBAL compared to 80% reported with FDA approved capecitabine, 2) a significantly longer half-life of 5-FU (i.e., 3-4 hours) than reported for FDA approved capecitabine (i.e., 30-60 minutes), and 3) 5-FU potency based on exposure per mg of capecitabine administered (i.e., AUC(0-inf)) being at least 50 x 5-FU potency based on the exposure reported for current FDA approved cape...