On May 18, 2023 Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) ("Processa" or the "Company") reported that it has received guidance from the U.S. Food and Drug Administration ("FDA") regarding the Company’s next trial for Next Generation Chemotherapy-Capecitabine ("NGC-Cap") (Press release, Processa Pharmaceuticals, MAY 18, 2023, View Source [SID1234631854]). The trial for NGC-Cap, the combination of PCS6422 and capecitabine, will be a Phase 2 safety-efficacy trial in colorectal cancer patients following the principles of FDA’s Project Optimus Oncology Initiative, the recent FDA recommendation on how oncology drugs are to be developed going forward.
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David Young, Pharm.D., Ph.D., Processa’s President and CEO, commented, "Our communications with the FDA have been extremely productive. One of the most important advantages of NGC-Cap and all our NGC drugs is that they have been designed to decrease the side effects associated with the treatment while increasing the exposure of cancer cells to proven cancer-killing molecules. These changes are expected to increase the number of patients who will benefit from each NGC drug given fewer side effects as well as have a significant impact on a patient’s response.
"By combining our NGCs and the Processa Regulatory Science Approach with FDA’s Project Optimus, Processa can efficiently provide better therapeutic options to cancer patients while increasing the likelihood of successful marketing approval. In addition, prior to approval, we expect to show that there are significant advantages to treating patients with our NGC drugs over both existing chemotherapy and oncology drugs directed toward new targets or new mechanisms. We look forward to continued collaboration with FDA and to providing continued updates to our shareholders," concluded Dr. Young.
The Phase 2 trial will be designed to determine the dose-and exposure-response relationships for both anti-tumor activity and safety/tolerability by evaluating different dosage regimens. The final dosage regimens to be used in the Phase 2 trial will be defined following the determination of the maximum tolerated dose from the Company’s ongoing Phase 1b trial and in collaboration with the FDA. To expedite the enrollment of the first patient, Processa has begun the upfront study preparation tasks, including protocol preparation for submission to the existing IND and clinical enrollment planning.