Pharma Focus Europe

Medivir Introduces an Improved Formulation of Fostrox, Essential for Facilitating a Planned Study Aimed at Accelerated Approval in the Second-line Treatment of Hepatocellular Carcinoma

Monday, November 27, 2023

Medivir AB (Nasdaq Stockholm: MVIR) recently reported the successful completion of the development of an updated formulation of fostrox, intended for commercial manufacturing. Fostrox, created by the pharmaceutical company with a focus on innovative cancer treatments, aims to tackle hepatocellular carcinoma (HCC), a potentially life-threatening form of liver cancer and the third leading cause of cancer-related deaths globally. The urgent need for new HCC treatments underscores the importance of this development in advancing fostrox as a potential therapeutic option for patients facing limited alternatives.

The formulation development process was conducted in collaboration with Quotient Sciences, Medivir's partner responsible for formulation development and drug product manufacture. Fostrox is currently undergoing evaluation in an ongoing phase 1b/2a study in combination with Lenvima®, a tyrosine kinase inhibitor. This open-label, multicenter study includes HCC patients who have not responded well to or cannot tolerate current first- or second-line treatments. Fostrox has shown promise in providing an alternative for HCC patients who have progressed on standard of care treatments.

The interim data from the study, with approximately 50% of patients still on treatment, reveals clinical benefits without compromising safety when fostrox is added to Lenvima in second-line HCC. Encouraged by these findings and recognizing the lack of approved medical treatments post-tumor progression on first-line standard of care, Medivir plans to initiate a phase 2b study with an accelerated approval intent.

A crucial milestone in clinical studies with regulatory intent is the development of a formulation suitable for commercial manufacture. Having successfully completed this program, Medivir is now poised to manufacture three different strengths of fostrox, along with a placebo, to facilitate the seamless progression of the fostrox development program and ensure a timely commencement of the planned phase 2b study.

Medivir, expressed satisfaction with the collaboration with Quotient Sciences in achieving the updated commercial formulation. Lindberg emphasized the importance of using the intended commercial launch formulation in the upcoming phase 2b study, highlighting its critical role in maintaining momentum in the fostrox development program.



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