Processa Pharmaceuticals

Apr 20, 2022

gorodenkoff/iStock via Getty Images Processa Pharmaceuticals (NASDAQ: PCSA ) said the first patient with advanced refractory gastrointestinal cancer was dosed in a maximum tolerated dose (MTD) phase 1b trial of next generation chemotherapy Capecitabine (a combination of PCS6422 and capecitabine). The company has amended the trial, which will provide a more precise timeline of dihydropyrimidine dehydrogenase (DPD) inhibition, among other things. The company previously said that a single dose of PSC6422 in this phase 1b trial successfully inhibited DPD, resulting in capecitabine ~50 times more potent than FDA approved capecitabine, but the improved potency did not last throughout the seven days of dosing. Combining capecitabine with PCS6422, an irreversible inhibitor of DPD, results in lower amounts of capecitabine needed to cause cell death, making the combo more potent and potentially safer, Processa (PCSA) said in an April 20 press release. "We expect to have preliminary data on a better Next Generation Capecitabine regimen by mid-2022 and anticipate that the MTD for Next Generation Capecitabine will be determined by the end of 2022. We then plan to move to either a Phase 2B or Phase 3 trial in 2023 based on our discussions with FDA,” said Processa (PCSA) Chairman and CEO David Young. To ensure this doesn’t happen in the future, please enable Javascript and cookies in your browser.