Medivir presents data that strengthens the fostrox/Lenvima combination in primary liver cancer at EASL Liver Cancer Summit
- Positive clinical pharmacokinetic data on fostrox presented at EASL Liver Cancer Summit.
- Results demonstrate dose linearity and alignment with safety profile in ongoing phase 1b/2a study.
- Exposure of fostrox unaffected by Lenvima administration, supporting combination therapy.
- Data strengthens confidence in fostrox's clinical development and upcoming regulatory interactions with FDA.
- None.
Insights
The pharmacokinetic data indicating dose linearity and consistent systemic exposure of fostroxacitabine bralpamide (fostrox) are critical for the optimization of dosing regimens in clinical settings. Dose linearity simplifies the process of adjusting dosages for different patient populations, ensuring that increases in dose correspond predictably to increases in drug concentration in the body. This is particularly important in oncology, where therapeutic windows can be narrow and drug concentrations must be managed carefully to balance efficacy and safety.
Furthermore, the lack of interaction between fostrox and Lenvima (lenvatinib) is a significant finding. Drug-drug interactions can lead to altered drug effects, potentially compromising patient safety or treatment efficacy. The reported compatibility of fostrox and Lenvima supports the rationale for their combined use in treating hepatocellular carcinoma (HCC), which could offer a more effective therapeutic strategy for patients with advanced liver cancer, a condition with limited treatment options.
The presentation of clinical pharmacokinetic modeling at a reputable conference such as the EASL Liver Cancer Summit underscores the progress of fostrox in the clinical development pipeline. The data from the phase I/IIa study are particularly valuable for understanding the drug's behavior in a target patient population. Advanced hepatocellular carcinoma (HCC) is a complex and aggressive disease and the development of new treatment options is of high interest to the medical community.
The positive safety and tolerability profile, combined with the ability of patients to remain on treatment long-term, provides a promising outlook for fostrox's potential impact on HCC treatment paradigms. The mention of upcoming regulatory interactions with the FDA suggests that the company is preparing for discussions that could lead to further clinical trials or even expedited pathways, depending on the strength of the data. Such developments could have significant implications for the company's valuation and investor interest.
Medivir's announcement regarding the pharmacokinetic data of fostrox presents an opportunity for investors to evaluate the company's pipeline potential. The emphasis on dose linearity and non-impact by Lenvima administration may signal a lower risk of developmental setbacks due to adverse drug reactions or complicated dosing adjustments. This can be an attractive point for investment as it suggests a smoother path toward market approval and commercialization.
Investor attention should also be directed towards the company's strategic positioning for upcoming FDA interactions. Positive regulatory feedback could lead to increased investor confidence and potentially impact Medivir's stock valuation. However, investors should remain cautious and seek to understand the broader competitive landscape of HCC treatments, as well as potential market sizes and penetration rates, before making investment decisions.
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.
For additional information, please contact;
Magnus Christensen, CFO, Medivir AB
Telephone: +46 8 5468 3100.
E-mail: magnus.christensen@medivir.com
About fostrox
Fostrox is a type of smart chemotherapy that delivers the cell-killing compound selectively to the tumor while minimizing the harmful effect on normal cells. This is achieved by coupling an active chemotherapy (troxacitabine) with a prodrug tail. The prodrug design enables fostrox to be administered orally and travel directly to the liver where the active substance is released locally in the liver. With this unique mechanism, fostrox has the potential to become the first liver-targeted, orally administered drug that can help patients with various types of liver cancer. A phase 1b monotherapy study with fostrox has been completed and a phase 1b/2a combination study in HCC is ongoing.
About primary liver cancer
Primary liver cancer is the third leading cause of cancer-related deaths worldwide and hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver. Although existing therapies for advanced HCC can extend the lives of patients, treatment benefits are insufficient and death rates remain high. There are approximately 660,000 patients diagnosed with primary liver cancer per year globally and current five-year survival is less than 20 percent1). HCC is a heterogeneous disease with diverse etiologies, and lacks defining mutations observed in many other cancers. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need.
About Medivir
Medivir develops innovative drugs with a focus on cancer where the unmet medical needs are high. The drug candidates are directed toward indication areas where available therapies are limited or missing and there are great opportunities to offer significant improvements to patients. Medivir is focusing on the development of fostroxacitabine bralpamide (fostrox), a smart, targeted chemotherapy designed to selectively treat liver cancer cells and to minimize side effects. Collaborations and partnerships are important parts of Medivir's business model, and the drug development is conducted either by Medivir or in partnership. Medivir's share (ticker: MVIR) is listed on Nasdaq Stockholm's Small Cap list. www.medivir.com .
1) Rumgay et al.,European Journal of Cancer 2022 vol.161, 108-118.
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SOURCE Medivir
FAQ
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