Development Strategy

Based on the positive phase II data in patients with OPC treated with Validive, Monopar is planning a phase III trial that will evaluate Validive compared to placebo in patients with OPC. This trial will follow an adaptive design that will stratify based on presence of HPV16 with an interim analysis that will assess futility and will allow for a sample size re-estimation based on the effect of Validive on incidence of SOM in patients with HPV+ vs HPV- OPC. Monopar is planning a single international trial to support marketing approval in the U.S. and E.U. and is working with the U.S. and E.U. regulatory agencies to design a development plan to move Validive toward registration in the most efficient and cost-effective way possible.