Stockholm, Sweden — Medivir AB (Nasdaq Stockholm: MVIR) reports today that the ninth and final patient was recruited to the phase Ia study of MIV-818 in patients with advanced liver cancer. Based on data from phase Ia, the initial dose of MIV-818 for the phase Ib study has been determined at 200 mg / week. The dosage is given as 40 mg / day for five days.
The phase I study with MIV-818, evaluating safety, tolerability and pharmacokinetics, consists of two parts: Phase Ia is an interpatient study while phase Ib has a classic 3 + 3 intrapatient dose-escalating design. A recommended dose for phase II will be based on the data in the phase Ib study. Medivir has previously reported that the intended liver-directed effect of MIV-818 could be verified already in the analysis of data from the first six patients. Efficacy data from the complete phase Ia study will be presented next year at a scientific conference.
“The initial data observed in the phase I study support our view that MIV-818 has the potential to provide a clear and much needed improvement in treatment for patients with liver cancer," said Dr. Uli Hacksell, CEO of Medivir. "MIV-8I8 is the most advanced drug candidate in a series of proprietary and wholly owned prodrugs that we intend to develop for the treatment of various cancer indications."
For further information, please contact:
Uli Hacksell, 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 to benefit patients with HCC and other forms of liver cancer. A phase I study in patients with liver cancer is ongoing.
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 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 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.