Processa Pharmaceuticals (NASDAQ: PCSA) today reiterates the strategic prioritization of its pipeline of proprietary oncology drugs, defined as Next Generation Chemotherapies (“NGCs”). According to the update, previous studies with these NGCs suggest potential improvement in the safety-efficacy profile, significantly differentiating these NGCs from their three presently widely used counterparts – capecitabine, gemcitabine and irinotecan. “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,” said Dr. David Young, Processa’s president and CEO. “Based on Processa’s regulatory science approach, which incorporates the principles associated with FDA’s Project Optimus Oncology Guidance, we have already begun to evaluate the safety-efficacy profiles including the dose-adverse event and dose-efficacy response relationship. By being able to understand these dose-response relationships, we should be able to better select dosage regimens of each Next Generation Chemotherapy treatment that will provide a better safety-efficacy profile than their widely used marketed counterpart drugs. Following this approach will not only increase the likelihood of obtaining FDA approval, but also provide the evidence that our Next Generation Chemotherapies are safer and more efficacious than the existing treatments.”
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About Processa Pharmaceuticals Inc.
The mission of Processa is to develop products with existing clinical evidence of efficacy for patients with unmet or underserved medical conditions who need treatment options that improve survival and/or quality of life. The company uses its Regulatory Science Approach criteria when selecting and developing drugs to achieve high-value milestones effectively and efficiently. Processa will prioritize the three Next Generation Chemotherapy oncology treatment programs: 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.
NOTE TO INVESTORS: The latest news and updates relating to PCSA are available in the company’s newsroom at https://ibn.fm/PCSA
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