Clinical Oncology Translational Study Phase-1 with Antitumor Phosphorylethanolamine (2-AEH2P) in Dogs with Neoplasms

The animal has the potential to serve as a clinical model for human disease, due to striking similarities and homologies in diseases. Early clinical development of a new drug may influence its final destination, and a careful and thoughtful approach to Phase-1 clinical trials is essential. Phosphorylethanolamine (2 AEH2P) is a new cytostatic phospholipid agent that, unlike most chemotherapeutic drugs used today, does not target DNA or cytoskeleton, but act on the cell membrane. Studies carried out by our group have shown several effects of 2-AEH2P controlling the progression of the cell cycle, in the alterations of the mitochondrial electrical potential capable of inducing apoptosis and autophagy in several types of human and animal tumor cells. The aim of this study is to establish the recommended safety dose of a 2-AEH2P monophosphoester, in dogs with tumor following the Phase 1 study model proposed by Fibonacci. The Phase-1 study following the Fibonacci model, 2-AEH2P was safe at all staggered doses up to 150 mg/Kg for 8 weeks. Intravenous administration in staggered doses according to the Fibonacci model, showed that the drug is safe, no advent of mortality during the study period or acute toxicity were observed. It is not a drug with hemolytic properties or that induces anemia. It does not lead to changes in liver and renal functions and was able to modulate leukocyte production. 2-AEH2P is new compound with antitumor potential, being useful for future veterinary and human tumors, as a combination of chemotherapeutic agents.