Pharma Focus Asia

Processa Pharmaceuticals Announces First Patient Dosed in the 300 mg Dose Group

Saturday, March 18, 2023

Processa Pharmaceuticals announced that the Company has dosed the first patient in its NGC-Capecitabine (combination of PCS6422 and capecitabine) 300 mg dose group. The Processa NGCs already have clinical evidence to support safety and efficacy while targeting patients who are in need of better treatment options for their cancer in order to improve survival and/or quality of life.

The 300 mg dose group will provide more information on the drug exposure vs adverse event relationship which is critical to FDA approval given the FDA’s Project Optimus Oncology initiative. In addition, the data obtained from this dose group will help to better understand how PCS6422 alters capecitabine metabolism to form more cancer-killing metabolites and fewer metabolites that only cause dose-limiting side effects.

Patients treated with Next Generation Chemotherapy-Capecitabine have NOT had hand-foot syndrome or cardiotoxicity adverse events, typically seen in 50-70% of patients presently on FDA-approved capecitabine.

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