Aura Renew Acq Regulatory News (ARA)

12 May 2005 07:00

Ardana PLC12 May 2005 ARDANA ANNOUNCES SUCCESSFUL RESULTS IN SECOND PHASE II STUDY OF TEVERELIX LA IN PROSTATE CANCER Edinburgh, UK, 12 May 2005; Ardana plc (LSE:ARA) the emerging pharmaceuticalcompany focused on improving human reproductive health, today announcessuccessful results of a second Phase II study of the Gonadotrophin ReleasingAntagonist (GnRH), Teverelix LA (Long Acting), in patients with advancedprostate cancer. The progression of prostate cancer is usually driven by male sex hormones(androgens) such as testosterone. It is widely accepted that reducing levels ofthese hormones in advanced disease can help slow the growth of the cancer andprolong survival. The production of testosterone can be reduced eithersurgically, with the removal of the testicles, or through drugs that affectproduction of testosterone. This study confirmed that Teverelix LA can attainand maintain suppression of testosterone to castration levels in patients withadvanced prostate cancer. In previous clinical studies Teverelix has been shown to reduce testosteronelevels rapidly to castration levels. In this trial Teverelix LA was tested at alower dose and administered via a different route (intramuscularly) compared tothe first Phase II study reported on 17 February 2005. In this second Phase II trial, 14 patients with advanced prostate cancer eachreceived two 90 mg doses of Teverelix LA. Each dose was administered as asingle intramuscular injection on Day 1 and Day 8 of the study. After the firstinjection, suppression of testosterone to castration levels (