Stock Performance and Market Reaction
Processa Pharmaceuticals Inc. (NASDAQ: PCSA) recently saw a significant uptick in its stock price, closing at $2.28, up by an impressive 34.12%. This surge is reflective of the market’s positive response to the company’s latest announcement regarding their lead product candidate. However, in after-hours trading, the stock experienced a slight dip to $2.19, down by 3.95%. Despite this minor decrease, the overall market sentiment towards Processa remains highly optimistic.
FDA Clears IND Application for Next Generation Capecitabine
On July 30, 2024, Processa Pharmaceuticals announced a major milestone: the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for their lead product candidate, Next Generation Capecitabine (NGC-Cap). This clearance supports the initiation of a Phase 2 clinical trial in patients with advanced or metastatic breast cancer, expected to begin enrollment this quarter.
Significant Advancement in Breast Cancer Treatment
David Young, PharmD, Ph.D., President of Research and Development at Processa, expressed pride in achieving this milestone for NGC-Cap. He highlighted the promising results from the Phase 1b study, which demonstrated that NGC-Cap is significantly more potent than monotherapy capecitabine, offering 5-10 times greater 5-fluorouracil exposure to cancer cells. This increased exposure resulted in greater efficacy with a safety profile comparable or superior to existing monotherapy treatments.
Addressing Unmet Needs in Chemotherapy
Despite capecitabine’s widespread use, especially for solid tumors, there remains a critical need for more effective treatments with fewer side effects. NGC-Cap aims to fulfill this need, potentially offering a more effective chemotherapy option with improved tolerability. Given that breast cancer is the second most common cancer and a leading cause of cancer-related death, the impact of such advancements cannot be overstated.
Details of the Phase 2 Study
The upcoming Phase 2 study will be a global, multicenter, open-label, adaptive design trial. It will compare two different doses of NGC-Cap to FDA-approved monotherapy capecitabine in approximately 60 to 90 patients with advanced or metastatic breast cancer. The trial aims to evaluate the safety and efficacy of NGC-Cap, determine optimal dosage regimens as per FDA’s Project Optimus Initiative, and explore the potential for personalized NGC-Cap therapy. Enrollment for the trial is expected to begin in the third quarter of 2024, with initial data anticipated by mid-2025.
Innovative Approach to Chemotherapy
NGC-Cap combines PCS6422, an irreversible dihydropyrimidine dehydrogenase (DPD) enzyme inhibitor, with low doses of capecitabine. Capecitabine, an oral prodrug of 5-FU, is extensively used in chemotherapy. The presence of the DPD enzyme often leads to the undesirable conversion of 5-FU into side-effect-causing molecules while reducing its efficacy against tumors. By inhibiting this enzyme, NGC-Cap enhances the exposure of cancer cells to 5-FU, thus improving its effectiveness and reducing side effects.
Promising Phase 1b Study Results
The Phase 1b study of NGC-Cap in patients with advanced gastrointestinal tract cancer showed promising results. Patients exhibited greater 5-FU exposure and lower fluoro-beta-alanine (FBAL) exposure compared to monotherapy capecitabine. Partial responses or stable disease were observed in 66.7% of evaluable patients, with progression-free survival ranging from 5 to 11 months.
About Processa Pharmaceuticals Inc.
Processa Pharmaceuticals is committed to developing Next Generation Chemotherapy (NGC) drugs with enhanced safety and efficacy. By modifying existing FDA-approved oncology therapies to alter their metabolism and distribution while maintaining their cancer-killing mechanisms, Processa aims to offer more effective and tolerable treatments for cancer patients. Leveraging their novel oncology pipeline and a robust Regulatory Science Approach, Processa strives to bring forth improved therapeutic options through an efficient regulatory pathway.
Conclusion
Processa Pharmaceuticals Inc. is at the forefront of innovation in chemotherapy, with its Next Generation Capecitabine offering promising improvements in cancer treatment. The positive market reaction underscores investor confidence in Processa’s future. As the company progresses with its Phase 2 clinical trial, there is significant hope for more effective and safer chemotherapy options for patients battling advanced or metastatic breast cancer.
