Replies to post #397 on Processa Pharmaceuticals Inc (PCSA)

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HANOVER, MD., June 11, 2024 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) (Processa or the Company), a clinical-stage pharmaceutical company focused on developing the next generation of chemotherapeutic drugs with improved efficacy and safety, today 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 (GI) cancer.

“We are encouraged by the preliminary efficacy analysis from our NGC-Cap Phase 1b dose-escalating safety/tolerability trial demonstrating some anti-tumor activity in patients with advanced GI cancer who have progressive cancer after relapsing or not responding to prior therapy. The favorable response is likely due to NGC-Cap’s ability to distribute more 5-FU to cancer cells than monotherapy capecitabine. The promising Phase 1b safety and tolerability profile plus these early efficacy signals provide validation for further development of NGC-Cap,” stated David Young, PharmD, Ph.D., President of Research and Development at Processa. “From this Phase 1b trial, we have been able to define the MTD and the RP2DR to use in our Phase 2 Optimal Dosage Regimen trial in breast cancer in the third quarter of 2024.”

Dr. Young added, “Given the need for more effective chemotherapy treatment with improved tolerability across multiple types of cancer, we believe that NGC-Cap has the potential to provide a safer, more efficacious option to treat the different cancers for which capecitabine and 5-FU are presently used.”

The NGC-Cap Phase 1b trial is evaluating ascending doses of capecitabine when administered after a single dose of PCS6422 in Stage III or IV patients with advanced, relapsed or refractory progressive GI cancer. All patients relapsed from or failed all other treatments, including prior treatment with capecitabine or 5-FU. For all doses of capecitabine in the Phase 1b NGC-Cap trial, exposure to 5-FU was greater and exposure to FBAL was lower with a better or similar side effect profile compared with monotherapy capecitabine. In addition, preliminary analysis of the efficacy data demonstrated early evidence of anti-tumor activity of capecitabine combined with PCS6422, which was assessed using RECIST 1.1 evaluations (Response Evaluation Criteria in Solid Tumors) by scans every eight weeks.