Processa Pharmaceuticals Announces First Patient Dosed in the 300 mg Dose Group with Next Generation Chemotherapy-Capecitabine

Processa Pharmaceuticals has reported the first patient dosed in the 300 mg dose group with its next-generation chemotherapy-capecitabine. The multi-center, randomized, open-label, dose-escalation trial is designed to evaluate the safety, efficacy, and pharmacokinetics of capecitabine in adult patients with solid tumors.

The objective of the trial is to determine the maximum tolerated dose, recommended dose, and pharmacokinetics of capecitabine in these patients. Processa is also investigating the effects of capecitabine on a variety of tumor markers and biomarkers associated with tumor growth.

The trial is enrolling patients with advanced or metastatic solid tumors with no known curative treatment options. The primary endpoint of the trial is to measure the incidence of dose-limiting toxicities. Secondary endpoints include assessment of overall response rate, progression-free survival, and pharmacokinetics of capecitabine.

Processa Pharmaceuticals has stated that the initiation of this trial marks a major milestone in its efforts to develop an innovative chemotherapy regimen. This next-generation chemotherapy-capecitabine is expected to provide more effective and less toxic treatment options for cancer patients.

The trial is being conducted at several clinical sites in the United States and Europe. Processa is hopeful that this trial will be successful and provide a meaningful treatment option for cancer patients.