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Preliminary results from Medivir Phase 2a study

The 15th patient with advanced hepatocellular carcinoma (HCC) has been included in the company’s ongoing phase 2a study.

The study evaluates safety and efficacy with the candidate drug fostrox in combination with Lenvima in patients for whom current first- or second-line treatment has proven ineffective or is not tolerable.

Positive results

The preliminary results from the initial phase 1b part were positive with a good safety and tolerability profile. The study, which is an open-label, multi-center, dose-escalation and dose-expansion study, continues to show encouraging clinical results as the disease has been stabilized in the majority of patients and they remain on treatment, states the company.

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The interest in including patients in the ongoing phase 2a study with fostrox + Lenvima has been great among both investigators and patients. The combination remains tolerable and only one patient has discontinued treatment due to side effects related to fostrox. Furthermore, the need for dose reductions has been lower than expected. The observed tolerability is of outmost importance as patients with HCC often have an increased sensitivity to drugs in general due to impaired liver function.

“The rapid inclusion of patients in phase 2a is a clear sign that the combination of fostrox and Lenvima is seen as an attractive treatment option and that the medical need for a new, effective treatment for HCC is large. We are very encouraged by the early signals of efficacy and good tolerability, and we look forward with confidence to presenting the data in more detail at an upcoming scientific congress,” says Pia Baumann, CMO, Medivir.

The promising observations in the phase 1b/2a study mean that Medivir, together with its Scientific Advisory Council, is intensifying preparations for the next phase in the clinical development of fostrox.

Photo of Pia Baumann: Medivir

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