Processa Completes Enrollment of 20 Patients for NGC-Cap Efficacy Study
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 05 2026
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Source: Globenewswire
- 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.
- Study Design: The randomized Phase 2 study, recommended by the FDA, compares NGC-Cap with standard capecitabine monotherapy, requiring participants to have undergone at least one prior cancer treatment, ensuring the validity and reliability of the data aimed at assessing NGC-Cap's advantages in safety and efficacy.
- 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.
- Interim Analysis Objectives: The interim analysis will evaluate the safety and preliminary efficacy of NGC-Cap versus mono-capecitabine, with potential adjustments to dosing or sample size based on findings, thereby guiding future clinical research to maximize therapeutic potential.
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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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Processa Completes Enrollment of 20 Patients for NGC-Cap Efficacy Study
- 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.
- Study Design: The randomized Phase 2 study, recommended by the FDA, compares NGC-Cap with standard capecitabine monotherapy, requiring participants to have undergone at least one prior cancer treatment, ensuring the validity and reliability of the data aimed at assessing NGC-Cap's advantages in safety and efficacy.
- 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.
- Interim Analysis Objectives: The interim analysis will evaluate the safety and preliminary efficacy of NGC-Cap versus mono-capecitabine, with potential adjustments to dosing or sample size based on findings, thereby guiding future clinical research to maximize therapeutic potential.
Continue Reading