Medivir AB (MVRBF.PK), a Swedish pharmaceutical company focused on cancer treatments, Tuesday announced that its ongoing phase 1b/2a study with Fostrox + Lenvima demonstrated further improvement in durable clinical benefit in advanced hepatocellular carcinoma or HCC.
These data, where all patients have had minimum 12 weeks follow-up, further supports accelerating the fostrox development program, and the company plans to initiate a registrational phase 2b study in second-line HCC in 2024.
Fostrox is an oral pro-drug, designed to selectively treat liver cancers and to minimize side effects. According to the company, it has the potential to become the first liver-targeted and orally administered drug for patients with HCC.
The latest data is from a phase 1b/2a open-label, multi-center, dose-escalation and dose-expansion study evaluating the safety and efficacy with fostroxacitabine bralpamide (fostrox) in combination with Lenvima in patients for whom current first- or second-line treatment has proven ineffective or is not tolerable.
Pia Baumann, CMO at Medivir, said, “Patients with advanced HCC, who have progressed on at least one prior line of treatment, is a difficult-to-treat population. Achieving durable clinical benefit for the majority of the patients with a good safety and tolerability profile, enables patients to benefit from the combination treatment longer. It provides us with added confidence in accelerating the fostrox development program…”
The company will present additional data from the ongoing phase 1b/2a study at the ASCO Gastrointestinal Cancers Symposium, January 18-20, 2024 in San Francisco, USA.
Medivir noted that Fostrox has completed a phase 1b monotherapy study, and a combination study in HCC currently ongoing.
In Stockholm, Medivir shares were trading at 2.82 Swedish kronor, up 1.3 percent.
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