NGC-Cap Demonstrates Superior Metabolite Profile and Reduced Toxicity in Advanced Breast Cancer Trial

Processa Pharmaceuticals’ investigational NGC-Cap compound has emerged from early Phase 2 analysis with compelling safety and exposure data, marking a significant advancement in addressing one of capecitabine therapy’s most limiting side effects. The trial contrasted NGC-Cap—a novel combination pairing PCS6422 with capecitabine—against standard capecitabine monotherapy in 16 evaluable breast cancer patients with advanced or metastatic disease.

Key Findings: Metabolite Exposure and Toxicity Reduction

The interim data reveals a fundamental shift in how the drug is metabolized. Patients receiving NGC-Cap (150 mg twice daily) achieved notably higher exposure to cancer-killing active metabolites compared to those on conventional capecitabine (1000 mg/m² twice daily), while paradoxically experiencing a dramatic reduction in dose-limiting toxicities. The most striking finding centers on FBAL, a toxic byproduct that historically drives capecitabine’s severe adverse events—NGC-Cap reduced FBAL exposure by up to tenfold compared to standard therapy.

Clinical Significance: Moving Beyond Hand-Foot Syndrome

Hand-foot syndrome represents the predominant barrier to capecitabine dose escalation in cancer treatment. The NGC-Cap arm demonstrated only Grade 1 manifestations of this condition, whereas the monotherapy cohort experienced Grade 2 severity. This distinction carries substantial clinical weight, as higher-grade hand-foot syndrome frequently forces dose reductions or treatment discontinuation, ultimately compromising therapeutic outcomes in breast cancer patients.

While side effects were numerically more frequent in the NGC-Cap group, their reduced severity profile suggests an improved tolerability window that could enable more consistent dosing and better patient compliance over extended treatment periods.

Next Steps and Market Response

Processa anticipates completing enrollment of 20 patients by early 2026, with a formal interim analysis examining both efficacy and safety endpoints. This expansion from the current 16-patient dataset will provide more robust statistical power to substantiate the preliminary observations around metabolite exposure optimization.

The market has responded decisively to the NGC-Cap progress. PCSA stock surged 97.67% in pre-market trading, establishing a new 52-week high at $5.94. Over the past twelve months, the stock has traded across a $0.10 to $27 range, reflecting the volatility typical of clinical-stage biotech names and significant confidence in the current Phase 2 trajectory. The Next Generation Cancer (NGC) platform’s core strategy—leveraging metabolic modulation to decouple efficacy from toxicity—appears to be resonating with investors as a potentially transformative approach to improving capecitabine therapy outcomes.