Processa Pharma Reports Positive Results from Phase 1b Trial of NGC-Cap in GI Cancer

Processa Pharmaceuticals, Inc., a clinical-stage pharmaceutical company, has announced promising results from its Phase 1b clinical trial of Next Generation Capecitabine (NGC-Cap) for patients with advanced gastrointestinal (GI) cancer. The trial aimed to determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose Range (RP2DR) for NGC-Cap, a drug developed to potentially enhance the efficacy and safety of existing chemotherapeutic treatments.

In the Phase 1b trial, NGC-Cap was studied in patients with Stage III or IV GI cancer who had relapsed or were unresponsive to prior treatments. The trial evaluated different doses of capecitabine, an oral form of 5-Fluorouracil (5-FU), administered after a single dose of PCS6422, a dihydropyrimidine dehydrogenase (DPD) enzyme inhibitor. The inhibition of DPD by PCS6422 is intended to increase the exposure of cancer cells to 5-FU while reducing the formation of metabolites that cause side effects.

The preliminary analysis of the trial results revealed encouraging signs of anti-tumor activity. Among the 12 evaluable patients, 66.7% (8 patients) achieved progression-free survival (PFS) ranging from 5 to 11 months. This included two patients with partial responses (PR) and six with stable disease (SD). Notably, at the highest NGC-Cap dose of 225 mg administered twice daily, all three evaluable patients had PFS with two PRs and one SD, with a PFS duration of approximately 5 to 7 months.

The findings indicate that NGC-Cap delivers higher 5-FU exposure and lower fluoro-beta-alanine (FBAL) exposure compared to capecitabine monotherapy, potentially offering a better or similar side-effect profile. Processa Pharmaceuticals plans to further evaluate these dosage regimens in a Phase 2 trial targeting breast cancer in the third quarter of 2024.

David Young, President of Research and Development at Processa, expressed optimism about the trial results, stating, "The preliminary efficacy analysis from our NGC-Cap Phase 1b dose-escalating safety/tolerability trial demonstrates some anti-tumor activity in patients with advanced GI cancer who have relapsed after prior therapies. These early efficacy signals, combined with the promising safety and tolerability profile, validate further development of NGC-Cap."

Processa Pharmaceuticals is dedicated to developing Next Generation Chemotherapy (NGC) drugs that aim to improve the safety and efficacy of cancer treatments. Their approach involves modifying existing FDA-approved oncology drugs to alter their metabolism and distribution while retaining their cancer-killing mechanisms. The company's team, boasting over 30 years of expertise, focuses on designing and conducting clinical trials that demonstrate a positive benefit/risk relationship.

The advantages of Processa's NGC drugs include fewer patients experiencing side effects that lead to dose discontinuation and a greater number of patients benefiting from the treatments. The company is currently working on several initiatives: initiating sites for the Phase 2 study to identify the optimal dosage regimen for NGC-Cap, defining the design for the Phase 2 study of Next Generation Gemcitabine (PCS3117) for various cancers, and outlining the formulation and toxicology program for Next Generation Irinotecan (PCS11T) for multiple cancer types.

The promising results of the Phase 1b trial mark a significant step forward in the development of NGC-Cap, and Processa Pharmaceuticals remains committed to advancing its oncology pipeline to provide safer and more effective cancer treatments.