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Processa Pharmaceuticals Announces Year-End 2021 Results and Provides Corporate Update
Targeting Major Milestones 2022 HANOVER, Md., March 30, 2022 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) ("Processa" or the "Company"),
About this update from Processa Pharmaceuticals, Inc.
[{"type":"text","content":"Targeting Major Milestones 2022 HANOVER, Md., March 30, 2022 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (\"Processa\" or the \"Company\"), a clinical stage company developing drugs for patients who have unmet medical conditions that require better treatment options to improve a patient’s survival and/or quality of life, today announced financial results for the year ended December 31, 2021, and provided a corporate update. Dr. David Young, CEO and chairman of Processa, commented, “Although COVID presented challenges for us and our industry in 2021, we commenced and enrolled patients in PCS499 for the treatment of uNL, PCS6422 (Next Generation Capecitabine) for the treatment of GI cancer, and received clearance for an IND for PCS12852 for gastroparesis. We were excited to learn that Next Generation Capecitabine is fifty times more potent than presently approved capecitabine and modified the protocol to further enhance the efficacy and safety of Next Generation Capecitabine. In addition, our modifications to the protocol now allow us to evaluate the possibility of treating patients using an individualized-personalized medicine approach for Next Generation Capecitabine. We completed the administrative efforts to commence our study in gastroparesis with the first patient to be dosed imminently. These efforts will produce three catalytic data events in the coming 9-10 months each in indications that could potentially exceed markets of $1 billion.” Recent Highlights and New Developments The Next Generation Capecitabine Phase 1B trial confirmed our hypothesis and provided insight into the importance of obtaining greater clarity on DPD inhibition and de novo formation, which could possibly lead to an individualized or personalized medicine approach to treating cancer patients.We have replaced non-performing sites and added remedial recruitment procedures to our PCS499 Phase 2B trial and expect to complete enrollment of the interim analysis cohort of patients mid-2022.We received clearance from FDA to proceed with a Phase 2A trial for the treatment of gastroparesis and anticipate enrolling the first patient in the first half of 2022 while completing the conduct of the trial in 2022.We are conducting a critical review of our clinical assets to assess opportunities to accelerate development and approval timelines. Up...