Medivir has completed a successful pre-IND meeting with the FDA

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Dec 12, 2022, 03:10 ET

STOCKHOLM, Dec. 12, 2022 /PRNewswire/ -- Medivir AB (Nasdaq: MVIR) (Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, announced today that the company has completed a pre-IND meeting with the US Food and Drug Administration and has received positive feedback on the development plan in preparation for an IND for its candidate drug fostroxacitabine bralpamide (fostrox). This is a significant step towards an application to include American study centers in future clinical trials (Investigational New Drug Application, IND).

Fostrox is an orally administered liver-targeted pro-drug currently undergoing phase 1/2a clinical trial in advanced hepatocellular carcinoma, in combination with pembrolizumab or lenvatinib.

The main purpose of the pre-IND meeting was to discuss the overall development plan in preparation for an IND for fostrox and identify any need for further data prior to submitting the IND application. Based on the meeting with the FDA and its recommendations, Medivir assesses that it can now proceed with the next step in the process towards an IND application. The company plans to submit an IND application to the US authority in 2023. An approved IND application is a prerequisite for conducting clinical studies with a new candidate drug in the United States.

For additional information, please contact
Magnus Christensen, CFO, Medivir AB
Telephone: +46 8 5468 3100. E-mail: [email protected]

About fostrox

Fostrox is a pro-drug designed to selectively treat liver cancers and to minimize side effects. It has the potential to become the first liver-targeted and orally administered drug for patients with HCC and other forms of liver cancer. Fostrox has completed a phase 1b monotherapy study, and a combination study in HCC currently 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 42,000 patients diagnosed with primary liver cancer per year in the US and current five-year survival is
11 percent. 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 pro-drug 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. Birinapant, a SMAC mimetic, is exclusively outlicensed to IGM Biosciences (Nasdaq: IGMS) to be developed in combination with IGM-antibodies for the treatment of solid tumors. Medivir's share (ticker: MVIR) is listed on Nasdaq Stockholm's Small Cap list. www.medivir.com.

The following files are available for download:

https://mb.cision.com/Main/652/3682952/1728848.pdf

Press release (PDF)

SOURCE Medivir