Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR) announces that new data from the completed phase Ia study with MIV-818 will be presented at the R&D day hosted by the company today, from 2 pm – 4.30 pm (CET).
The primary objective of the phase Ia study was to evaluate safety and tolerability of MIV-818 in liver cancer patients. A total of nine patients with advanced disease were included: six patients with metastatic liver cancer, two with hepatocellular carcinoma and one with intrahepatic cholangiocarcinoma.
The pharmacokinetic analysis showed that patients were exposed only to low levels of MIV-818 and troxacitabine outside of the liver, providing experimental support for MIV-818’s liver targeting. The adverse events were mainly mild and the more serious side effects observed were reversible.
Biomarker analysis of liver biopsies from patients showed a selective liver cancer effect of MIV-818: while tumor tissue had clear DNA damage, healthy liver tissue showed only minimal or no DNA damage. Based on an independent expert analysis of liver tumor growth, five of the nine patients were assessed to have stable liver disease after treatment.
- The analysis of data from the nine patients confirms our conclusion from the first six patients and provides strong support for the continued development of MIV-818 as a new and effective treatment for liver cancer. MIV-818 is our most important project and therefore it feels very good that our confidence in the possibilities of the compound is further strengthened by the new data presented today, says Medivir's CEO, Dr. Uli Hacksell.
The R&D Day will be streamed via a link on the website: www.medivir.com.
For further information, please contact:
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 08.30 CET on 2 March, 2020.
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.
Medivir develops innovative drugs with a focus on cancer where the unmet medical needs are high. The company is investing in 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. www.medivir.com.