Processa Pharmaceuticals (NASDAQ: PCSA) Reports Successful Phase 1b Safety Evaluation Data

DENVER, Colo., Jan. 25, 2023 (247marketnews.com)- Processa Pharmaceuticals, Inc. (NASDAQ:PCSA) reported, this morning, the successful completion of the safety tolerability evaluation in its Phase 1b trial of Next Generation Capecitabine (“NGC-Cap”) and that “NGC-Cap was better tolerated with positive preliminary efficacy results than FDA-approved capecitabine.”

Two dosage regimens have been selected for the Phase 2 trial, from the Phase 1b data, which will be in advanced or metastatic breast cancer given FDA’s agreement that the Phase 1b data can be used to support the design of the Phase 2 trial in breast cancer.

Processa Pharmaceuticals is trading at $2.8594, up $0.8094 (+39.48%), on 641.6K shares traded.

Its 52-week range is $2.02 to $25.40. It new a 52-week low yesterday, so this is well above that level.

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 drug development 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 www.processapharma.com.

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