NGC-Cap Breakthrough: Processa Achieves Higher Metabolite Levels While Slashing Toxicity in Breast Cancer Trial

Processa Pharmaceuticals (PCSA) just dropped some impressive preliminary Phase 2 results that could reshape how we think about cancer treatment. Their lead candidate NGC-Cap, combining PCS6422 with capecitabine, is showing something oncologists have been chasing for years: better efficacy without the brutal side effects.

Here’s what makes this significant. Traditional capecitabine therapy helps breast cancer patients, but it comes with a nasty trade-off—dose-related toxicities that severely impact quality of life. Hand-foot syndrome, in particular, limits how aggressively doctors can treat patients. Processa’s Next Generation Cancer (NGC) platform takes a different approach: it reformulates how the body metabolizes the drug, enhancing the good while blocking the bad.

The Trial Numbers Tell the Story

The Phase 2 study enrolled 19 advanced or metastatic breast cancer patients split into two groups. One group received NGC-Cap at 150 mg twice daily, while the control arm got standard capecitabine at 1000 mg/m2 twice daily. After analyzing the first 16 patients, the data revealed something compelling: NGC-Cap patients showed significantly elevated exposure to active cancer-fighting metabolites—the compounds that actually kill tumor cells.

The side effect profile is where things get really interesting. While NGC-Cap patients experienced adverse events at similar or slightly higher frequencies compared to monotherapy, the severity dropped dramatically. The key differentiator? Toxic catabolite FBAL exposure was slashed by up to 90%, dropping tenfold compared to standard capecitabine. This translated to only mild Grade 1 hand-foot syndrome in the NGC-Cap arm versus Grade 2 symptoms in patients on traditional monotherapy.

What’s Next

Processa expects to complete enrollment of 20 patients, with formal interim analysis results anticipated in early 2026. This analysis will evaluate both efficacy endpoints and safety durability—critical data for determining whether this improved metabolite exposure actually translates to better patient outcomes.

Market Reaction

The market clearly thinks there’s something here. PCSA stock surged 97.67% in pre-market trading and hit a new 52-week high at $5.94. The stock has ranged from $0.10 to $27 over the past year, suggesting investors see potential in this metabolite-focused approach to cancer therapy. Whether this enthusiasm is justified depends entirely on what the 2026 efficacy data reveals—but early signals are undeniably promising for shareholders and, more importantly, for patients desperately needing better treatment options.