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Processa Pharmaceuticals Announces Prioritization on Development of Next Generation Chemotherapies
Our Next Generation Chemotherapies (NGCs) are cancer treatments where the metabolism and/or distribution of an FDA-approved drug has been altered to provide
About this update from Processa Pharmaceuticals, Inc.
[{"type":"text","content":"Our Next Generation Chemotherapies (NGCs) are cancer treatments where the metabolism and/or distribution of an FDA-approved drug has been altered to provide potentially safer and more effective chemotherapy to cancer patients.Based on preliminary clinical and pre-clinical studies, more cancer patients should benefit from our NGCs than their FDA-approved counterpart drugs.Our Regulatory Science approach, encompassing the principles of FDA’s Project Optimus and Oncology Guidance, should increase the likelihood of approval.FDA meetings are planned in 2023 to discuss the next phases of development and our plan to include the principles of Project Optimus and the Oncology Guidance.Opportunities to monetize or partner non-oncology assets are being evaluated. HANOVER, MD, Feb. 21, 2023 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (“Processa” or the “Company”) reiterates the strategic prioritization of its pipeline of proprietary oncology drugs, defined as Next Generation Chemotherapies (NGCs). Previous studies with these NGCs suggest potential improvement in the safety-efficacy profile will significantly differentiate these NGCs from their three presently widely used counterparts - capecitabine, gemcitabine, and irinotecan. Much of oncology research and drug development focuses on the search for a new or different way to treat cancer. Processa’s approach is to modify and improve three different, widely used chemotherapy treatments with a proven history of successfully treating many cancer patients but also having a high rate of non-responders and a significant number of patients who must decrease the dose or discontinue treatment because of adverse events. The NGCs have been modified using a proprietary approach such that they are metabolized and/or distributed differently in the body than their approved counterpart drugs, while still maintaining the same mechanism of killing the cancer cells. Dr. David Young, Processa’s President and CEO stated, “The Company’s Next Generation Chemotherapy treatments have the potential to extend the survival and/or quality of life for more cancer patients than their existing counterpart drugs while decreasing the number of patients who are required to dose adjust or discontinue treatment because of adverse events. Based Processa’s Regulatory Science approach which incorporates the ...