Welcome to our dedicated page for Processa Pharmaceuticals news (Ticker: PCSA), a resource for investors and traders seeking the latest updates and insights on Processa Pharmaceuticals stock.
Processa Pharmaceuticals develops clinical-stage therapies centered on Next Generation Cancer (NGC) drug products. Company news commonly covers NGC-Cap, its lead oncology asset combining PCS6422 with capecitabine, including clinical updates in advanced or metastatic breast cancer and disclosures on metabolite exposure, safety profile and therapeutic-index objectives.
Updates also address the company's broader pipeline and business priorities, including PCS499 for focal segmental glomerulosclerosis, partnership activity for non-oncology assets, capital actions, conference participation, governance matters and operating or financial results tied to its development-stage biotechnology model.
Processa Pharmaceuticals (Nasdaq: PCSA) has received FDA clearance for its Investigational New Drug (IND) application for Next Generation Capecitabine (NGC-Cap), paving the way for a Phase 2 clinical trial in advanced or metastatic breast cancer. The open-label study, set to begin enrollment in Q3 2024, will compare two doses of NGC-Cap to FDA-approved monotherapy capecitabine in 60-90 patients. Initial data is expected mid-2025.
NGC-Cap demonstrated 5-10 times more 5-fluorouracil exposure to cancer cells in a Phase 1b study, potentially offering greater efficacy with a similar or better safety profile than existing capecitabine treatments. The trial aims to evaluate NGC-Cap's safety-efficacy profile, determine optimal dosage regimens, and explore personalized therapy options for breast cancer patients.
Processa Pharmaceuticals (Nasdaq: PCSA) has appointed Russell L. Skibsted as its new Chief Financial Officer (CFO), effective immediately. Skibsted, with nearly 30 years of experience in the pharmaceutical industry, succeeds James Stanker, who is retiring but will stay on in an advisory role to assist with the transition.
Skibsted brings expertise in financial management, global business development, capital markets, investor relations, and operations. He has worked with public and private life sciences companies at various stages of development. His most recent role was as Senior Vice President and CFO of Alimera Sciences, a publicly traded global ophthalmic pharmaceuticals company.
CEO George Ng expressed confidence in Skibsted's ability to contribute to Processa's advancement of its pipeline through clinical trials, citing his proven record in finance and capital markets, combined with a deep understanding of life sciences complexities.
Processa Pharmaceuticals has announced positive results from their Phase 1b trial of NGC-Cap in gastrointestinal cancer patients. The trial involved 12 patients, with 66.7% achieving progression-free survival (PFS) ranging from 5 to 11 months. At the highest dose, all patients showed PFS, with two partial responses and one stable disease. Compared to monotherapy capecitabine, 5-FU exposure was greater, and FBAL exposure was lower, with better or similar side effects. These promising results support further development, with a Phase 2 trial in breast cancer slated for the third quarter of 2024.
Processa Pharmaceuticals, Inc. (PCSA) will participate in the EF Hutton Annual Global Conference on May 15, 2024, in New York City. The company aims to develop advanced chemotherapeutic drugs for improved efficacy and safety.
Processa Pharmaceuticals, Inc. appointed Dr. Steven Cha as Senior Vice President of Clinical Research. Dr. Cha brings extensive experience in oncology drug development, having guided multiple oncology therapies through all phases of development, including regulatory approval and commercialization. His leadership will be important as Processa advances its oncology programs, with plans to initiate a Phase 2 trial in breast cancer.
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