Processa Pharmaceuticals (NASDAQ: PCSA) is a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs to improve the efficacy and safety for more patients suffering from cancer. The company today announced the outcomes from a successful meeting with the U.S. Food and Drug Administration (“FDA”) regarding Processa’s next Phase 2 study supporting the advancement of Next Generation Capecitabine (“NGC-Cap”) for cancer patients. “The FDA provided helpful guidance on the overall design of our NGC-Cap Phase 2 study for which we anticipate beginning enrollment in mid-2024. We believe that NGC-Cap may provide a better safety/efficacy profile than FDA-approved Capecitabine, eventually providing treatment for the tens of thousands of patients who cannot tolerate the existing Capecitabine,” said David Young, PharmD, Ph.D, president of research and development at Processa. “The results to date of our present Phase 1b oncology study clearly show that the metabolism and distribution of NGC-Cap is better than Capecitabine and that the safety/efficacy profile will likely be significantly better once we can identify the optimal dosage regimen.”
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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. By combining Processa’s novel oncology pipeline with proven cancer-killing active molecules and the Processa Regulatory Science Approach as well as experience in defining Optimal Dosage Regimens for FDA approvals, Processa not only will be providing better therapy options to cancer patients but also increase the probability of FDA approval for its Next Generation Chemotherapy (“NGC”) drugs following an efficient path to approval. Processa’s 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. The company’s approach to drug development is based on more than 30 years of drug development expertise to efficiently design and conduct clinical trials that demonstrate a positive benefit/risk relationship. The Processa team has a track record of obtaining over 30 approvals for indications across almost every division of FDA. Using its proven Regulatory Science Approach, the Processa Team has experience defining the Optimal Dosage Regimen using the principles of the FDA’s Project Optimus Oncology initiative. The advantages of Processa’s NGCs are expected to include fewer patients experiencing side effects that lead to dose discontinuation, more significant cancer response and a greater number of patients — in excess of 200,000 for each NGC drug — who will benefit from each NGC drug. Currently under development are 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, 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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