On February Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, reported that clinical pharmacokinetic (PK) data on dose linearity and systemic exposure from the first study with fostroxacitabine bralpamide (fostrox) (NCT03781934) will be presented at the European Association for the Study of the Liver (EASL) Liver Cancer Summit on February 23, 2024, in Rotterdam (Press release, Medivir, FEB 22, 2024, View Source [SID1234640405]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
The abstract, titled "Population pharmacokinetic modeling of orally administered fostroxacitabine bralpamide (fostrox, MIV-818) and its metabolite troxacitabine in a phase I/IIa liver cancer study" will be presented at the conference by Karin Tunblad PhD, Project Director for fostrox at Medivir. The presentation includes pharmacokinetic results from 42 patients in the phase I/IIa clinical study with fostrox monotherapy and the fostrox + Lenvima combination in advanced liver cancer.
The results show dose linearity and that the systemic exposure, at the recommended phase 2 dose for fostrox, aligns with the encouraging safety and tolerability profile experienced in the ongoing phase 1b/2a study with fostrox in combination with Lenvima in second line treatment of advanced hepatocellular carcinoma (HCC). In addition, the study shows that the exposure of fostrox is not impacted by administration of Lenvima, providing additional support for this combination.
– "Ensuring predictable exposure is crucial when combining two pharmaceutical drugs. The data presented at EASL strengthen the clinical results previously reported where patients treated with fostrox + Lenvima have shown good tolerability and ability to stay on treatment long-term. The data further supports our upcoming regulatory interactions with FDA and continues to build our confidence in the clinical development of fostrox," says Pia Baumann, Chief Medical Officer at Medivir.
The abstract and the poster will be available on Medivir’s website after the presentation.