Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR) today announced that the last patient has undergone the safety follow-up to identify potentially dose-limiting toxicity from the first part of the phase Ib study with the company's leading candidate drug, MIV-818, against liver cancer. The results were positive and the recommended dose for the next phase has thus been determined.
At present, three patients continue to be active on treatment within the study, and they will continue treatment until intolerable side effects or disease progression occur. The second part of the phase Ib study, where MIV-818 is given together with standard treatment, is planned to be initiated during the second half of 2021.
- The results continue to be promising and show a good safety and tolerability profile. The study is proceeding according to plan and now the recommended starting dose has been set for the next study where we combine MIV-818 with standard treatment. We now look forward to initiating that study during the second half of 2021, said Yilmaz Mahshid, CEO of Medivir.
Details of the coming study are planned to be presented during the second quarter of 2021. Detailed results from the first part of the phase Ib study are expected to be presented at an upcoming scientific conference.
For further information, please contact:
Yilmaz Mahshid, CEO, Medivir AB, phone: +46 (0)8 5468 3100.
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 for patients with HCC and other forms of liver cancer.
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 can extend the lives of patients, treatment benefits are insufficient and death rates remain high. HCC is a very diverse disease with multiple cancer cell types and without 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.
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 developing MIV-818, a pro-drug designed to selectively treat liver cancer cells and to minimize side effects. It has the potential to become the first liver-targeted, orally administered drug for patients with HCC.
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.