Processa Pharmaceuticals (NASDAQ: PCSA), a clinical-stage pharmaceutical company developing the next generation of chemotherapeutic drugs, today announced plans to expand the development of Next Generation Capecitabine (“NGC-Cap”) into the treatment of advanced or metastatic breast cancer beginning with its next Phase 2 trial. NGC-Cap combines the administration of PCS6422, the company’s irreversible dihydropyrimidine dehydrogenase (“DPD”) enzyme inhibitor, with the administration of low doses of the commonly used chemotherapy capecitabine, which is already approved as both monotherapy and combination therapy in breast cancer. The decision to begin with a Phase 2 trial in breast cancer followed Processa’s meeting with the FDA, where it was agreed that pursuing breast cancer would lead to a more efficient development program while providing a greater likelihood of FDA approval. “We believe the pursuit of an advanced or metastatic breast cancer indication for NGC-Cap is a logical progression for Processa as it represents a larger market than colorectal cancer with the potential to differentiate NGC-Cap from the presently approved capecitabine as well as other treatments for breast cancer. The FDA and Processa discussed the advantages and disadvantages of developing NGC-Cap in breast cancer and concluded that the development would be a more efficient and straightforward path to approval with an easier enrollment process for the Phase 2 and 3 trials,” said David Young, PharmD, Ph.D., president of research and development at Processa.
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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 Processa’s 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. The company’s approach to drug development, based on more than 30 years of experience, uses its proven Regulatory Science Approach, including the determination of the Optimal Dosage Regimen using the principles of the FDA’s Project Optimus Oncology initiative. 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 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 —- over 250,000 patients treated each year for each 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 breast, metastatic colorectal, gastrointestinal, 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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