PS5-09-17: Phase 1 results of a Phase I II study of Pharmacokinetics and Safety of Epidiferphane and Taxanes in Breast Cancer Patients

Abstract Phase 1 results of a Phase I/II study of Pharmacokinetics and Safety of Epidiferphane and Taxanes in Breast Cancer Patients Pre-clinical studies in mouse models given chemotherapy regimens containing paclitaxelhave shown that Epidiferphane (EDP) delays tumor progression and reduces both neuropathy and anemia. In an Investigational New Drug Phase I/II trial investigating Epidiferphane in patients with breast cancer receiving a taxane-containing chemotherapy regimen, phase I has completed enrollment. In phase I, we evaluated the safety and pharmacokinetics of two EDP dose levels in neoadjuvant and metastatic breast cancer patients. No dose limiting toxicities were encountered and pK and adverse events are presented. In phase II, we will assess the safety and efficacy at reducing neuropathy and anemia and improving tumor response and patient quality of life in breast cancer patients of adding EDP to taxane containing chemotherapy regimens. We will be assessing the correlation of neuropathy and anemia with the level of neurofilament light chain, VEGFA, Nrf2, NF-κB and IL18. This correlation will determine if EDP is having a similar effect to that seen in the mice and if these markers may be useful in predicting and targeting toxicity. Our intervention will determine pharmacokinetics of and test a novel therapy for safety and effectiveness at improving response to chemotherapy, improve quality of life, and reducing cytopenias and peripheral neuropathy in patients. If effective, this therapy will: improve treatment regimens by making current chemotherapy regimens more effective, less toxic, and impact survival - ie allowing full dose chemotherapy without the side effects of neuropathy, anemia, and other cytopenias. Citation Format: C. Heldermon, K. Daily, D. Ogden, P. Gurjar, D. Lyon, B. Reynolds. Phase 1 results of a Phase I II study of Pharmacokinetics and Safety of Epidiferphane and Taxanes in Breast Cancer Patients abstract. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr PS5-09-17.