Preliminary data shows PCS6422+Capecitabine enhances cancer metabolite exposure with comparable safety to capecitabine alone.
Quiver AI Summary
Processa Pharmaceuticals, Inc. reported promising preliminary Phase 2 data for their combination treatment, NGC-Cap, which pairs PCS6422 with capecitabine for patients with advanced or metastatic breast cancer. The findings from the first 16 of 19 participants indicate that NGC-Cap significantly enhances exposure to capecitabine's cancer-fighting metabolites without increasing the severity of side effects compared to standard capecitabine therapy. Notably, while there was a higher incidence of side effects related to the active metabolites in the NGC-Cap group, their severity remained similar to those receiving the standard treatment. Importantly, patients on NGC-Cap experienced significantly less exposure to harmful catabolite metabolites linked to dose-limiting toxicities. Processa plans to complete enrollment of the full study cohort by the end of Q1 2026 and expects a comprehensive analysis of efficacy and safety by early 2026, reflecting their commitment to developing safer, more effective cancer therapies.
Potential Positives
- Preliminary Phase 2 data indicate that the combination treatment of PCS6422 and capecitabine significantly increases exposure to cancer-killing metabolites while maintaining comparable safety profiles to standard monotherapy.
- The results suggest a potential for improved clinical efficacy and tolerability, which is a crucial objective for the company's Next Generation Cancer platform.
- The company is on track for a formal interim analysis in early 2026, showing commitment to advancing its clinical development process.
- Processa Pharmaceuticals positions NGC-Cap as a key value driver with the opportunity to enhance treatment outcomes for patients with advanced or metastatic breast cancer.
Potential Negatives
- Data from only 16 out of 19 patients were available for preliminary analysis, raising concerns about the completeness and reliability of the findings.
- The increased exposure to active metabolites in NGC-Cap also led to a higher total number of side effects per patient compared to standard therapy, indicating potential safety concerns despite similar severity.
- The formal interim analysis is not expected until early 2026, suggesting a delayed timeline for stakeholders seeking more conclusive data on the treatment's effectiveness and safety.
FAQ
What are the preliminary results for PCS6422+Capecitabine?
Preliminary Phase 2 data shows PCS6422+Capecitabine increases cancer-killing metabolites while maintaining similar safety to capecitabine monotherapy.
When is the full interim analysis expected?
The full interim analysis of the Phase 2 study is expected in early 2026.
What does NGC-Cap aim to achieve?
NGC-Cap aims to enhance exposure to effective cancer-killing metabolites while reducing harmful side effects in breast cancer treatment.
How many patients are enrolled in the Phase 2 study?
Nineteen patients are currently enrolled in the ongoing Phase 2 study evaluating NGC-Cap.
What safety results have been observed with NGC-Cap?
The severity of side effects with NGC-Cap is similar to capecitabine alone, while ensuring greater exposure to effective metabolites.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
Preliminary Phase 2 data demonstrate PCS6422+Capecitabine increased cancer-killing metabolite exposure while maintaining comparable safety to monotherapy capecitabine
Company on track to conduct formal interim analysis in early 2026
VERO BEACH, Fla., Dec. 17, 2025 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a clinical-stage biopharmaceutical company developing Next Generation Cancer (NGC) therapies, today 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 (Mono-Cap). 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.
“These emerging data continue to validate the central premise of our Next Generation Cancer strategy,” said Dr. David Young, President of Research and Development at Processa. “NGC-Cap (capecitabine combined with PCS6422) appears to meaningfully increase exposure to the capecitabine metabolites responsible for killing cancer cells, while reducing exposure to the catabolite metabolites associated with dose-limiting toxicity such as hand-foot-syndrome (HFS), a profile that is difficult to achieve with conventional Mono-Cap dosing.”
“As we approach our planned interim analysis, we believe NGC-Cap continues to demonstrate a differentiated pharmacologic profile that could meaningfully improve the therapeutic index of capecitabine-based therapy,” said George Ng, Chief Executive Officer of Processa Pharmaceuticals. “We view this program as a key value driver for the Company and an important opportunity for patients with advanced or metastatic breast cancer.”
Preliminary Phase 2 study findings suggest that NGC-Cap may allow patients to receive greater exposure to the most effective cancer-killing components of therapy while avoiding increased severity of side effects commonly associated with standard treatment. The Company believes this balance between potential efficacy and tolerability is central to improving outcomes in patients with advanced breast cancer.
Key Safety and Pharmacokinetic Observations
19 patients have been randomized to receive either NGC-Cap (150 mg twice daily) or a standard-dose Mono-Cap (1,000 mg/m² twice daily). The evaluation of safety data from the first 16 patients provides preliminary findings consistent with higher exposure to active cancer-killing metabolites in the NGC-Cap arm. The data from all 19 patients were not available for this preliminary analysis.
As expected with increased exposure to active metabolites, a greater proportion of patients receiving NGC-Cap experienced side effects related to these capecitabine cancer-killing metabolites, and the total number of such side effects per patient was higher compared to patients receiving capecitabine alone. Importantly, the severity of these side effects was similar between treatment arms, indicating that the increased activity did not translate into more severe toxicity.
In addition to forming active metabolites, capecitabine is also broken down into catabolite metabolites, including FBAL, which are associated with certain side effects such as HFS. Patients receiving NGC-Cap demonstrated substantially lower exposure to FBAL — up to ten times less than with Mono-Cap.
Consistent with this reduced exposure, the number of patients reporting HFS was similar between treatment groups, but patients in the NGC-Cap arm experienced only mild (Grade 1) symptoms, while patients receiving capecitabine monotherapy experienced symptoms of greater severity (up to Grade 2).
“What we are seeing in patients aligns closely with our pharmacologic expectations,” added Dr. Young. “The distribution and severity of observed side effects are consistent with enhanced exposure to active cancer-killing metabolites and reduced formation of catabolites, including FBAL.”
Upcoming Clinical Milestone
Processa anticipates completing enrollment of the final patient in the formal 20-patient interim analysis of Phase 2 safety and efficacy study by the end of the first quarter of 2026, in accordance with the trial protocol.
About PCS6422+Cap (NGC-Cap)
NGC-Cap is Processa’s lead oncology asset and a key component of its Next Generation Cancer (NGC) platform. When administered, NGC-Cap is designed to increase systemic exposure to active cancer-killing anabolite metabolites while reducing formation of toxic catabolite metabolites, potentially improving the therapeutic index of Capecitabine-based therapy.
About Processa Pharmaceuticals, Inc.
Processa is a clinical-stage pharmaceutical company focused on developing the Next Generation Cancer (NGC) drugs with improved safety and efficacy. Processa’s NGC drugs are modifications of existing FDA-approved oncology therapies resulting in an alteration of the metabolism and/or distribution of these drugs while maintaining the existing mechanisms of killing the cancer cells. By combining its novel oncology pipeline with proven cancer-killing active molecules and its Regulatory Science Approach, Processa’s strategy is to develop more effective therapy options with improved tolerability for cancer patients through an efficient regulatory path. In addition to its core oncology programs, Processa is actively pursuing strategic partnerships for non-oncology assets to unlock additional value.
For more information, visit our website at www.processapharma.com .
Forward-Looking Statements
This release contains forward-looking statements. The statements in this press release that are not purely historical are forward-looking statements which involve risks and uncertainties. Actual future performance outcomes and results may differ materially from those expressed in forward-looking statements. Please refer to the documents filed by Processa Pharmaceuticals with the SEC, specifically the most recent reports on Forms 10-K and 10-Q, which identify important risk factors which could cause actual results to differ from those contained in the forward-looking statements.
Company Contact:
Patrick Lin
(925) 683-3218
[email protected]
Investor Relations:
Dave Gentry
RedChip Companies, Inc.
1-407-644-4256
[email protected]
