Strong Ph II data for Ardana's Teverelix LA

Edinburgh, UK-based Ardana's Phase II repeat-dose study of its lead development compound, the gonadotrophin-releasing hormone antagonist Teverelix LA (long-acting), in patients with prostate cancer demonstrated testosterone suppression for 28 weeks using an alternative formulation for the first time.

Previous Phase II studies have confirmed that Teverelix LA can attain and maintain suppression of testosterone to castration level (< 0.5ng/ml) for up to eight weeks in patients with prostate cancer. This new study, using a one-month dosing regime repeated every four weeks up to the 24th week, achieved results consistent with those previously reported. The study utilized an alternative lyophilized formulation offering improvements over the existing powder fill presentation such as process scalability, product stability and potentially lower costs of production, Ardana noted. Company chief executive Huw Jones said: "this is the first time this formulation has been used in a clinical setting and it has produced good results. The lyophilized formulation has a number of potential advantages which can be used in the further development of Teverelix."

Testosterone levels at baseline were 3.7 ng/ml. Suppression in testosterone was attained within two days of dosing to a median value of 0.40ng/ml. Median testosterone values remained at or below the castration threshold of 0.5ng/ml from two weeks following the first injection of Teverelix LA until the end of the study at week 28. Mean prostate-specific antigen levels were reduced by 75% within four weeks of the first injection of Teverelix LA. Steady-state plasma levels of the drug were achieved within four weeks of dosing, Ardana added.