Processa Pharmaceuticals announced positive efficacy results from the preliminary evaluation of its recently completed Phase 1b clinical trial which defined the Maximum Tolerated Dose, MTD, and Recommended Phase 2 Dose Range, RP2DR, for Next Generation Capecitabine, NGC-Cap, administered to patients with Stage III or IV gastrointestinal tract cancer. Key Efficacy Findings from Preliminary Analysis of NGC-Cap Phase 1b Clinical Trial: In all evaluable patients receiving one dose of PCS6422 and seven days of capecitabine, PR or SD was observed in 66.7% of evaluable patients, including two with PR and six with SD. The length of PFS was approximately 5 to 11 months across these patients. At the MTD of 225 mg of capecitabine dosed twice daily after a single dose of PCS6422, all three evaluable patients had PFS with the time to progression being approximately 5 to 7 months. At the second highest dose of 150 mg capecitabine dosed twice daily after a single dose of PCS6422, 66.7% of evaluable patients had SD with the time to progression of approximately 3 to 7 months. These two dosage regimens will be further evaluated in the Phase 2 trial in breast cancer patients to determine the optimal dosage regimen for the pivotal trial. By comparison, in the capecitabine product label, 301 metastatic colorectal cancer patients treated with monotherapy capecitabine had an overall response rate of approximately 21% and the time to progression of approximately 4.5 months.
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