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InvestorNewsBreaks – Processa Pharmaceuticals Inc. (NASDAQ: PCSA) Presents New Data from NGC-Cap Phase 1b Trial at AACR Annual Meeting

Processa Pharmaceuticals (NASDAQ: PCSA), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs to improve the efficacy and safety for more patients suffering from cancer, participated at this year’s annual American Association for Cancer Research (“AACR”). According to the announcement, the company presented two abstracts at the conference, including new phase 1b data on its Next Generation Capecitabine (“NGC-Cap”) product. The data indicated that NGC-Cap demonstrated greater 5-FU exposure than monotherapy capecitabine at a significantly lower dose with a favorable clinical safety profile, showing that NGC-Cap has potential for improved efficacy in more patients due to an increase in distribution of 5-FU to cancer cells. “The most recent data for the phase 1b NGC-Cap study presented at AACR highlight NGC-Cap’s ability to distribute more 5-FU to cancer cells with five to ten times greater systemic exposure than when capecitabine is administered alone,” said Processa Pharmaceuticals president of research and development David Young, PharmD, PhD, in the press release. “As expected with a higher systemic exposure, there was a greater incidence of adverse events with NGC-Cap. However, these adverse events were less dose limiting than seen with other 5-FU metabolites. This phase 1b study is ongoing due to continued patient response, and we plan to release final trial data once the database is locked. Given we have identified the recommended phase 2 doses and the maximum tolerated dose, we look forward to advancing NGC-Cap into a phase 2 trial in breast cancer later this year. As agreed to with the FDA, our data in past and ongoing studies will be used to support the breast cancer phase 2 trial, which streamlines the regulatory path for NCG-Cap.”

To view the abstracts, visit

To view the full press release, visit

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, the company not only will provide better therapy options to cancer patients but will also increase the probability of FDA approval for its next-generation chemotherapy drugs following an efficient path to approval. Processa’s NGC drugs are modifications of existing FDA-approved oncology drugs resulting in an alteration of the metabolism and/or distribution of these drugs while maintaining the existing mechanisms of killing the cancer cells. The company’s approach to drug development is based on more than 30 years of expertise to efficiently design and conduct clinical trials that demonstrate a positive benefit/risk relationship. The Processa team has a track record of obtaining more than 30 approvals for indications across almost every division of the FDA. Using its proven Regulatory Science Approach, the Processa team has experience defining the Optimal Dosage Regimen using the principles of the FDA’s Project Optimus Oncology initiative. 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 — in excess of 200,000 for each NGC drug — who will benefit from each NGC drug. Currently under development are three NGC treatments: Next Generation Capecitabine (PCS6422 and capecitabine to treat breast, metastatic colorectal, gastrointestinal, pancreatic and other cancers), Next Generation Gemcitabine (PCS3117 to treat pancreatic, biliary, 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

NOTE TO INVESTORS: The latest news and updates relating to PCSA are available in the company’s newsroom at

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