Processa Pharmaceuticals Updates on NGC-Cap Clinical Trial Progress
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 17 2025
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Processa Pharmaceuticals provided a clinical update on its ongoing Phase 2 study of NGC-Cap, the combination treatment of PCS6422 and capecitabine, in patients with advanced or metastatic breast cancer. Data from the first 16 of 19 patients enrolled indicate that NGC-Cap significantly increases exposure to capecitabine cancer-killing drug metabolites without increasing the severity of side effects compared to standard monotherapy capecitabine therapy. This profile suggests the potential for improved clinical efficacy while maintaining manageable safety, a key objective of Processa's NGC platform. The full interim analysis from the first 20 patients enrolled in the study, which will include efficacy and safety data, is expected in early 2026.
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About PCSA
Processa Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of Next Generation Cancer therapy (NGC) small molecules. The three NGC treatments in its pipeline are NGC-Capecitabine (NGC-Cap), PCS3117, also referred to as NGC-Gemcitabine (NGC-Gem) and PCS11T, also referred to as NGC-Irinotecan (NGC-Iri) and two non-oncology drug assets are PCS12852, and PCS499. NGC-Cap is a combination of PCS6422 and capecitabine, capecitabine being the oral prodrug of the cancer drug 5-fluorouracil.PCS3117 is an oral analog of gemcitabine that is converted to its active metabolite by a different enzyme system than gemcitabine. PCS11T is a prodrug of the active metabolite of irinotecan (SN-38). PCS12852 is a specific and potent 5HT4 agonist that is in Phase IIB and is a potential treatment for diabetic gastroparesis patients. PCS499 is a drug that can be used to treat unmet medical needs and conditions caused by multiple pathophysiological changes.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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- Clinical Trial Progress: Processa Pharmaceuticals has completed the enrollment and dosing of 20 patients, laying the groundwork for the upcoming interim analysis of NGC-Cap, with preliminary safety and efficacy data expected in Q1 2026, which will provide critical insights for optimizing future treatment strategies.
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- Innovative Treatment Regimen: NGC-Cap combines PCS6422 with capecitabine, designed to enhance the generation of cancer-killing metabolites while reducing the formation of side-effect-related metabolites, potentially significantly improving patient treatment experiences and outcomes.
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