Processa Pharmaceuticals, Inc. (NASDAQ:PCSA) stock is skyrocketing on Wednesday, with a session volume of 2.73 million compared to the average volume of 389.09 thousand, as per data from Benzinga Pro.
Processa Pharmaceuticals on Wednesday 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).
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).
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.
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.
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 hand-foot-syndrome (HFS) that causes redness, swelling, tingling, pain, blistering, and peeling.
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).
Next Steps
Processa anticipates completing enrollment of the final patient in the formal 20-patient interim analysis of the Phase 2 safety and efficacy study by the end of the first quarter of 2026.
PCSA Price Action: Processa Pharmaceuticals shares were up 130.95% at $6.94 at the time of publication on Wednesday, according to Benzinga Pro data.
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