Processa Pharmaceuticals (Heatwurx Acquired Promet), Inc. (Nasdaq: PCSA) (“Processa” or the “Company”) is focused on developing its Next Generation Chemotherapies (NGCs) to improve the safety-efficacy profile of the three widely used treatments – capecitabine, gemcitabine, and irinotecan. These proprietary NGCs have the potential to revolutionize cancer treatment and offer a significant advantage over existing therapies.
Processa has taken a unique approach to oncology research and drug development, modifying and improving three widely used chemotherapy treatments with a proven history of success. These modified NGCs, through a proprietary approach, are metabolized and/or distributed differently in order to increase efficacy while reducing side effects. This allows cancer patients to receive the same cancer-fighting benefits without the negative effects of standard treatments, giving them a better chance of beating the disease.
Processa’s President and CEO, Dr. David Young, is confident that the Company’s Next Generation Chemotherapy treatments have the potential to drastically improve the survival and quality of life for cancer patients, as well as reduce the number of patients who have to discontinue treatment due to adverse events. By utilizing Regulatory Science principles and FDA’s Project Optimus Oncology Guidance, Processa is able to analyze the safety-efficacy profiles and dose-response relationships. With this information, Processa is able to select dosage regimens of each Next Generation Chemotherapy treatment that will provide a better safety-efficacy profile than the existing treatments. This not only increases the likelihood of FDA approval, but also presents evidence that the Next Generation Chemotherapies are safer and more effective than current treatments.
The Company has an innovative pipeline of three NGC treatments, each of which offers unique solutions to various medical issues. The first is a novel cell therapy that harnesses the power of the body’s own immune system to fight cancer. The second is a gene therapy that can treat certain rare genetic diseases. Finally, the third treatment is an advanced gene editing tool that can be used to treat a wide range of diseases. These treatments offer hope to those struggling with debilitating medical conditions, and have the potential to revolutionize the healthcare industry.
NGC-Capecitabine, a combination of PCS6422 and capecitabine, is up to fifty times more potent and has an improved safety profile when compared to capecitabine alone. This novel formulation could be used to treat metastatic colorectal, gastrointestinal, breast, and pancreatic cancers in an estimated 200,000 patients in the United States alone who are expected to be diagnosed in 2022. Consequently, we plan to meet with the FDA in the first half of 2023 to discuss the Phase 2B trial design, incorporating the FDA’s Project Optimus Oncology initiative and the Oncology Guidance. If funded, we anticipate initiating the trial in the second half of 2023.
NGC-Gemcitabine is an oral analog of gemcitabine that has been proven to be effective in both gemcitabine patients as well as some gemcitabine treatment-resistant patients. With an estimated 275,000 people in the United States diagnosed with pancreatic, lung, ovarian, and breast cancer in 2022, NGC-Gemcitabine could potentially be used to treat these patients. We are aiming to meet with the FDA in 2023 to discuss potential study designs, including the FDA’s Project Optimus Oncology initiative and the Oncology Guidance, with the aim of submitting the Phase 2B protocol to the IND in the second half of 2023. With successful funding requirements, the trial could be initiated soon after the submission of the protocol.
NGC-Irinotecan (PCS11T) is a prodrug of the active metabolite of irinotecan (SN-38) that offers an improved safety profile compared to its predecessor. This is due to its unique chemical structure, which allows it to be more readily absorbed into cancer cells than normal cells. Clinical trials are projected to begin in 2023, with the potential to offer a new treatment option to the estimated 200,000 patients in the United States who have been diagnosed with lung, colorectal, gastrointestinal, and pancreatic cancer in 2022. With its lower doses and greater efficacy, NGC-Irinotecan could be a life-saving treatment for many.
In line with the Company’s new focus and resource allocation to NGC drugs, the Company has begun engaging with potential licensing partners, as well as exploring other avenues to capitalize on PCS12852 and PCS499. Moving forward, the Company will continue these efforts to maximize the potential of these valuable drugs.
About Processa Pharmaceuticals, Inc.
Processa is dedicated to bringing treatments to those with unmet or underserved medical conditions. With their Regulatory Science Approach, they strive to identify and develop high-value drugs that offer improved survival and quality of life. Their main focus is on Next Generation Chemotherapy oncology treatments, such as 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). In doing so, Processa is committed to providing patients with solutions that will improve their lives.