Medivir AB, a pharmaceutical company dedicated to developing innovative treatments for cancer, has successfully completed the initial dose escalation phase of its 1b/2a study on fostroxacitabine bralpamide (fostrox) in combination with Lenvima® for hepatocellular carcinoma (HCC). This is a major step forward in the effort to provide new and effective treatments for this devastating disease.
The preliminary results from the dose cohorts have been overwhelmingly positive, with no dose-limiting toxicity and a good safety and tolerability profile. Encouragingly, the recommended dose (RP2D) for the first combination arm of the phase 2a part of the study has been determined to be 30 mg for fostrox. This is a promising development that could pave the way for further progress in treating the condition.
Medivir AB is excited to announce the completion of the first part of its study with promising preliminary results, enabling the launch of the first combination arm in the phase 2a part of the study. After seeing a high level of interest in the study, the company is pleased to offer a new combination treatment of Lenvima® and Fostrox, with the hope of providing more advanced HCC patients with better clinical responses. CEO Jens Lindberg stated, “We are thrilled to be able to provide this new treatment option to those in need. We believe it will make a real difference in the lives of many patients.”
The Fostrox multi-center study is a pioneering open-label trial that combines the drug with either Lenvima®, a tyrosine kinase inhibitor, or Keytruda®, an anti-PD-1 checkpoint inhibitor. This is being done with the goal of improving outcomes for patients with HCC who have not responded to or tolerated first-line treatments. The phase 1b dose escalation part with Keytruda is ongoing and currently six patients are actively participating. The study aims to assess the safety, tolerability, and potential efficacy of the combined treatments.
In this exciting phase 2a study, up to 30 patients with HCC will have the opportunity to be evaluated for safety and efficacy. The study is taking place at 14 different clinics across the UK, Spain, and South Korea, so don’t miss out!
Fostrox is an exciting, pioneering pro-drug designed to specifically target liver cancers and reduce side effects. It could be the first orally administered drug to treat HCC and other types of liver cancer, and has already completed a phase 1b monotherapy study, with a combination study also in progress. This is a potential breakthrough for those living with liver cancer, offering a new hope for treatment.
About primary liver cancer
HCC, the most common form of primary liver cancer, is a deadly disease that kills thousands of people every year. With only 11% five-year survival rate, it is a devastating diagnosis that leaves many patients and families with a grim prognosis. Despite recent advances in therapies, the benefits are still insufficient, leaving a large unmet medical need. Adding to the challenge is the fact that HCC is a heterogeneous disease with diverse etiologies and lacks defining mutations observed in many other cancers, which has hindered the success of molecularly targeted agents in treating this condition.
At Medivir, we are dedicated to developing innovative drugs to treat cancer and other serious illnesses where current treatments are limited or non-existent. Our key drug candidate, Fostroxacitabine Bralpamide (Fostrox), is specifically designed to selectively target liver cancer cells while minimizing side effects. Additionally, we have partnered with IGM Biosciences to outlicense Birinapant, a SMAC mimetic, which is being developed in combination with IGM-antibodies to treat solid tumors. We are constantly striving to create groundbreaking treatments to improve the lives of patients around the world.