Processa Pharmaceuticals (NASDAQ: PCSA) today announced its receipt of guidance from the U.S. Food and Drug Administration (“FDA”) regarding the company’s next trial for Next Generation Chemotherapy-Capecitabine (“NGC-Cap”). The phase 2 safety-efficacy trial will study a combination of PCS6422 and capecitabine for 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. “Our communications with the FDA have been extremely productive,” said David Young, Pharm.D., Ph.D., Processa’s president and CEO. “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.”
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About Processa Pharmaceuticals Inc.
Processa is a clinical stage pharmaceutical company focused on developing Next Generation Chemotherapy (“NGC”) drugs intended to improve the safety, tolerability and efficacy of cancer treatment. Some of the key advantages of Processa’s NGCs are expected to be fewer patients experiencing side effects that lead to dose discontinuation, more significant cancer response, and an increase in the number of patients who will benefit from each NGC drug. The NGC drugs are modifications of existing FDA-approved oncology drugs resulting in an alteration of the metabolism and/or distribution of these FDA-approved drugs while maintaining the existing mechanisms of killing the cancer cells. By combining the proven cancer-killing active molecules and the Processa Regulatory Science Approach with FDA’s new Project Optimus Oncology Initiative, Processa can provide better therapeutic options to cancer patients more efficiently while increasing the probability of FDA approval. Using its Regulatory Science Approach, the Processa team has consistently demonstrated its ability to obtain FDA approvals as evidenced by over 30 approvals for indications across almost every division of the FDA. The company’s pipeline includes three Next Generation Chemotherapy oncology treatments: Next Generation Capecitabine (“PCS6422” and capecitabine to treat metastatic colorectal, gastrointestinal, breast, pancreatic, and other cancers), Next Generation Gemcitabine (“PCS3117” to treat pancreatic, biliary duct, lung, ovarian, breast, and other cancers), and Next Generation Irinotecan (“PCS11T” to treat lung, colorectal, gastrointestinal, pancreatic, and other cancers). For more information, visit the company’s website at www.ProcessaPharma.com.
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