Pharmaceuticals Company Announces FDA Clearance For Breast Cancer Clinical Trial
Processa Pharmaceuticals Announces FDA Clearance of IND Application for Phase 2 Clinical Trial of NGC-Cap in Breast Cancer.
Disclaimer: The following article is intended for informational purposes only. It does not constitute medical advice and should not be used as a substitute for professional healthcare consultation.
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Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a clinical-stage pharmaceutical company dedicated to developing next-generation chemotherapeutic drugs with enhanced efficacy and safety, has announced a major development. The U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for their lead product candidate, Next Generation Capecitabine (NGC-Cap). This approval paves the way for the initiation of a Phase 2 clinical trial in patients with advanced or metastatic breast cancer, which is set to begin enrollment this quarter.
Achieving a Milestone
David Young, PharmD, Ph.D., President of Research and Development at Processa Pharmaceuticals, expressed his pride in reaching this crucial milestone for NGC-Cap. He emphasized the clinical potential of this treatment, particularly for patients with advanced or metastatic breast cancer, where capecitabine is a standard therapy.
In previous Phase 1b studies, NGC-Cap demonstrated higher potency compared to monotherapy capecitabine. The treatment provided up to five to ten times more 5-fluorouracil (5-FU) exposure to cancer cells, resulting in greater efficacy while maintaining a safety profile comparable or superior to existing capecitabine monotherapy. Young anticipates initial data from the forthcoming Phase 2 trial to be available by mid-2025. Despite capecitabine being one of the most widely used chemotherapy drugs, especially for solid tumors, there remains an unmet need for more effective treatments with fewer or less severe side effects. Processa Pharmaceuticals believes that NGC-Cap can fulfill this need, offering a potent alternative with a potentially improved safety-efficacy profile.
Breast cancer is the second most common cancer worldwide and a leading cause of cancer-related deaths. In 2022 alone, over 2 million cases were diagnosed, resulting in more than 665,000 deaths globally. For those diagnosed with metastatic disease, the five-year survival rate is approximately 30%.
The upcoming Phase 2 study will be a global multicenter, open-label, adaptive design trial. It aims to compare two different doses of NGC-Cap with FDA-approved monotherapy capecitabine in approximately 60 to 90 patients with advanced or metastatic breast cancer. The trial's primary objectives are to evaluate the safety and efficacy profiles of NGC-Cap versus monotherapy capecitabine, determine the optimal dosage regimens required by the FDA Project Optimus Initiative, and assess the potential for personalizing NGC-Cap therapy. Processa Pharmaceuticals expects to enroll the first patient by the third quarter of 2024.
About Capecitabine Administered with PCS6422 (NGC-Cap)
NGC-Cap involves the administration of PCS6422, an irreversible dihydropyrimidine dehydrogenase (DPD) enzyme inhibitor, in combination with low doses of capecitabine. Capecitabine is an oral prodrug of 5-FU, a widely used chemotherapy drug, particularly for solid tumors. Upon oral ingestion, capecitabine metabolizes into 5-FU in the body, which then transforms into molecules called anabolites that actively target duplicating cells, such as cancer cells, and catabolites that primarily cause side effects.
The DPD enzyme plays a critical role in the undesirable conversion of 5-FU to catabolites, thereby reducing tumor exposure to 5-FU and its anabolites. By inhibiting the DPD enzyme, PCS6422 helps enhance the therapeutic efficacy of capecitabine while potentially minimizing its side effects. The NGC-Cap Phase 1b study evaluated ascending doses of capecitabine combined with a fixed dose of PCS6422 in patients with advanced, relapsed, or refractory progressive gastrointestinal tract cancer. This study highlighted the potential of NGC-Cap in improving the treatment outcomes for patients with various cancers.
As the Phase 2 clinical trial for NGC-Cap gets underway, there is a sense of cautious optimism among the scientific and medical communities. The potential for NGC-Cap to offer a more effective and safer chemotherapy option is a promising development in the fight against advanced and metastatic breast cancer. With the FDA's clearance of the IND application, Processa Pharmaceuticals is poised to make strides in cancer treatment.
Disclaimer: The information provided in this article is for informational purposes only and should not be considered as medical advice. Consult with healthcare professionals for any medical concerns or questions.
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