Medivir AB, a pharmaceutical company focused on developing treatments for cancer in areas of high unmet medical need, has selected a global CRO partner for the planned phase 2b study evaluating fostroxacitabine bralpamide (fostrox) + Lenvima vs Lenvima alone in second line HCC.
 
In the next phase of development, Medivir is planning for a global, randomized phase 2b study aligned with its recent supportive Type C interaction with the FDA. The objective is to evaluate the combination of fostrox + Lenvima in second line advanced HCC with the aim of becoming the first approved treatment alternative after current first line treatment.
 
The study is planned to enroll patients broadly in the U.S., EU and Asia, building on countries and sites participating in currently ongoing phase 1b/2a, which will ensure that recruitment requirements for a potential accelerated or conditional approval are fulfilled. A key next step is to initiate study feasibility to identify optimal sites and investigators to enable study start in early 2025. Already now, we have received high level of interest from experts in HCC regarding potential participation in the study.
 
“With the selection of a CRO partner, following our recent Type C meeting with the FDA, we are confidently moving forward with the enhanced phase 2b study design. It has been a thorough process to select the best possible partner to ensure optimal execution of the upcoming study across all geographies. The selected CRO partner has a global footprint, with a strong track record in performing oncology studies in general and HCC studies in particular. We are now moving forward with next steps, which include performing the feasibility, operational and regulatory study preparations as well as finalization of the study protocol to open an IND in the USA,” says Malene Jensen, VP Clinical Development at Medivir.