First liver cancer patient dosed in the MIV-818 phase Ib study

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Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR) today announced that the first patient with advanced liver cancer has been dosed in the phase Ib study of MIV-818. The MIV-818 phase I study (NCT03781934) consists of two parts: (i) the already completed phase Ia, which was a within-patient dose-escalation study, and (ii) the phase Ib between-patient dose-escalation study, a classic 3+3 dose-escalation multi-center study in patients with advanced liver cancer.

The phase Ia study demonstrated a liver-cancer directed effect of MIV-818 and five out of nine patients were considered to have stable liver disease after MIV-818 treatment.

The primary objective of the phase Ib study is to establish the safety and tolerability profile of MIV-818. A secondary objective is to further explore the efficacy of MIV-818.

"Patients with advanced liver cancer have limited treatment options and the unmet medical need is large" said Dr Uli Hacksell, CEO of Medivir. "Having obtained an encouraging proof-of-concept for the liver-cancer directed effect of MIV-818 in phase Ia, we hope to get additional supportive data from the phase Ib study. We believe that MIV-818 has the potential to provide liver cancer patients with major therapeutic benefits."  

For further information, please contact:
Dr Uli Hacksell, CEO, Medivir AB, phone: +46 (0)8 5468 3100.

Medivir AB is obliged to make this information public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.55 CET on 10 March, 2020.

About liver cancer
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 are capable of extending the lives of patients, treatment benefits are low while death rates remain high. HCC is a very diverse disease with multiple cancer cell types and without the tumor-specific mutations seen in other tumor types. 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 MIV-818
MIV-818 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, orally administered drug to benefit patients with HCC and other forms of liver cancer.

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. 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.



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