Policy & Regulation
Medivir anounces selection of global CRO for Phase 2b study in HCC with fostrox + Lenvima
19 June 2024 -

Pharmaceutical company Medivir AB (NASDAQ: MVIR) (STOCKHOLM: MVIR), a specialist in innovative cancer treatments, announced on Wednesday that it has selected a global contract research organization (CRO) for its upcoming phase 2b study. This study will evaluate fostroxacitabine bralpamide (fostrox) combined with Lenvima against Lenvima alone in second-line hepatocellular carcinoma (HCC).

The phase 2b study, planned as a global, randomised trial, follows a supportive Type C interaction with the FDA. Its aim is to establish fostrox + Lenvima as the first approved treatment alternative after current first-line therapies. Patient enrollment will span the US, EU and Asia, leveraging sites involved in the ongoing phase 1b/2a study to meet recruitment needs for potential accelerated or conditional approval. Study feasibility efforts to identify optimal sites and investigators will begin soon, targeting an early 2025 start.

Fostrox is a liver-targeted inhibitor of DNA replication, designed to selectively deliver the cell-killing compound to tumours while minimizing effects on normal liver cells. This unique mechanism allows for oral administration, with the active substance released locally in the liver. Fostrox has shown promising efficacy and a good safety profile in phase 1b/2a trials.

Primary liver cancer, particularly HCC, is the third leading cause of cancer-related deaths globally and the fastest-growing cancer in the USA. Despite existing therapies extending patient lives, high mortality rates persist, especially in the second line where no approved treatments exist post-first-line standard care. With around 660,000 global diagnoses annually and a five-year survival rate of less than 20%, there is a critical unmet need for effective second-line treatments.

Medivir focuses on developing drugs for cancers with high unmet medical needs, such as fostrox, which is designed to selectively target liver cancer cells while minimizing side effects. The company pursues collaborations and partnerships to advance its drug development initiatives.