Processa Pharmaceuticals (NASDAQ: PCSA), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, today announced that it has received approval from the U.S. Food and Drug Administration (“FDA”) for its Investigational New Drug (“IND”) application for its lead product candidate, Next Generation Capecitabine (“NGC-Cap”). According to the announcement, the FDA clearance enables the commencement of a Phase 2 clinical trial in patients with advanced or metastatic breast cancer. The Phase 2 study, which is expected to begin enrollment this quarter, will be a global multicenter, open-label, adaptive design trial comparing two different doses of NGC-Cap to FDA-approved monotherapy capecitabine in about 60 to 90 patients with advanced or metastatic breast cancer. “We are proud to achieve this significant milestone for NGC-Cap and look forward to entering the clinic for the treatment of advanced or metastatic breast cancer, where capecitabine is a standard of care. We previously demonstrated in our Phase 1b study that NGC-Cap is more potent than monotherapy capecitabine, providing up to 5-10 times more 5-fluorouracil exposure to cancer cells. This greater exposure resulted in a greater efficacy, with a safety profile better or similar to existing monotherapy with capecitabine,” said David Young, PharmD, Ph.D., President of Research and Development. “Initial data from the Phase 2 trial are expected mid-2025.”
To view the full press release, visit https://ibn.fm/nEy2H
About Processa Pharmaceuticals Inc.
Processa is a clinical-stage pharmaceutical company focused on developing the Next Generation Chemotherapy (“NGC”) drugs to improve the safety and efficacy of cancer treatment. Processa’s NGC drugs are modifications of existing FDA-approved oncology drugs resulting in an alteration of the metabolism and/or distribution of these drugs while maintaining the existing mechanisms of killing the cancer cells. By combining its novel oncology pipeline with proven cancer-killing active molecules and its Regulatory Science Approach, Processa’s strategy is to develop more effective therapy options with improved tolerability for cancer patients through an efficient regulatory pathway. For more information, visit the company’s website at www.ProcessaPharma.com.
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