Shares of Medivir AB (MVIR) were gaining around 11 percent in the early morning trading in Sweden after the pharmaceutical company focused on cancer treatments Monday announced promising interim safety and efficacy data, including a first complete response in phase 1b/2a HCC study with fostrox in combination with Lenvima in advanced hepatocellular carcinoma or HCC.
The phase 1b/2a study of first-in-class candidate drug fostrox in combination with Lenvima in HCC patients for whom current first- or second-line treatment has proven ineffective or is not tolerable is ongoing.
The company noted that central review of the 6 patients in phase 1b dose escalation part was performed. In these 6 patients, complete response was recorded in 1 patient, partial response in 2 patients, and stable disease in 2 patients read by an independent radiologist using mRECIST.
The interim results confirmed the previously announced favorable safety and tolerability profile. The company noted that no new or unexpected safety events and the combination continues to be tolerable.
The phase 2a dose expansion part of the study is ongoing and is now fully recruited. The company plans to present data from phase 1b/2a at an upcoming scientific congress.
Pia Baumann, CMO at Medivir, said, “HCC patients, for whom current first- or second-line treatment has proven ineffective, is a difficult-to-treat patient group and expectation regarding clinical benefit and tumor shrinkage is low. This is why it is so encouraging to see that overall response is shown in 3 out of 6 patients and even more so that a complete response was recorded in one patient. Considering that the medical need for a new, effective treatment for HCC is large, these are very encouraging data for the future development of fostrox.”
In Stockholm, Medivir shares were trading at 7.97 Swedish kronor, up 10.7 percent.
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