Teverelix LA achieves 8-week suppression

Edinburgh, UK-based Ardana has reported positive preliminary results from a Phase II study in patients with prostate cancer demonstrating a new dose regimen extended to eight weeks from four weeks for its lead development compound, the gonadotrophin antagonist Teverelix Long-Acting.

According to Ardana, it is widely accepted that reducing levels of male sex hormones like testosterone in advancedstage disease can help slow the growth of the cancer and prolong survival. Previous Phase II studies have confirmed that Teverelix LA can attain and maintain suppression of testosterone to castration level for at least four weeks in patients with prostate cancer. This new study has demonstrated a dosage regime that can extend this to at least eight weeks, Ardana noted.

In this randomized Phase II evaluation, 38 patients with prostate cancer were assessed using duration of suppression of testosterone to below castration level (< 0.5ng/ml) as the primary endpoint. Preliminary study results show that mean testosterone levels in the higher and lower dose groups at baseline were 3.71ng/ml and 4.3ng/ml, respectively. Suppression of testosterone was attained in both dose groups by day three in 18 of 20 and 14 of 18 patients, respectively. Preliminary data from the higher dose group shows that reduction of testosterone levels to castration level was attained in 19 out of 20 patients. For these 19, the duration of castration was between 54 and 147 days, Ardana stated.