Aura Renew Acq Regulatory News (ARA)

14 Feb 2007 07:00

Ardana PLC14 February 2007 ARDANA ANNOUNCES FAVOURABLE PRELIMINARY RESULTS FOR TEVERELIX LA IN DEVELOPMENT FOR PROSTATE CANCER Edinburgh, UK, 14 February 2007 - Ardana plc (LSE:ARA) today announcespreliminary results from a study in male subjects of its lead developmentcompound, the GnRH antagonist Teverelix Long Acting (LA). This study, which ispart of the ongoing clinical development of Teverelix LA for the treatment ofadvanced prostate cancer, is the first to be completed under a grantedInvestigational New Drug (IND) application for Teverelix LA. The progression of prostate cancer is driven by male sex hormones (androgens)such as testosterone. It is widely accepted that reducing levels of thesehormones in advanced disease can help slow the growth of the cancer and prolongsurvival. The production of testosterone can be reduced either surgically, withthe removal of the testes, or through medicines that affect production oftestosterone. Previous Phase II studies have confirmed that Teverelix LA canattain and maintain suppression of testosterone to castration levels in patientswith advanced prostate cancer. This study was designed to establish whether the pharmacokinetics andsubsequently the effectiveness of Teverelix LA in suppressing testosteronelevels is similar in normal weight and obese subjects, an issue raised by theUnited States Food and Drug Administration (FDA) at a previously reportedpre-IND meeting held in 2005. This open-label, Phase I study in males, involved 22 normal weight subjects witha Body Mass Index (BMI) between 18.5 and 25, and 22 obese subjects with a BMIgreater than 30. All subjects received Teverelix LA administered as a singlesubcutaneous injection. The primary endpoint was a comparison between the twogroups of the pharmacokinetics of Teverelix LA, including mean maximum druglevel and area under the curve (a measure of the total amount of drug absorbedby the body). A comparison of the effects of Teverelix LA on serum testosteronelevels was the key secondary endpoint. Study results provide evidence that, overan 8-week period, there were no differences between the groups in terms of boththe pharmacokinetics of Teverelix LA and its effect on testosterone suppression. An additional Phase II study in patients with advanced prostate cancer iscurrently ongoing, with results expected in the second quarter of 2007.Teverelix LA is also in development for the treatment of benign prostatichyperplasia and endometriosis. Dr. Maureen Lindsay, Ardana's CEO, said: "We are very encouraged by theprogress made in the development of Ardana's long-acting formulation ofTeverelix. This programme of studies continues to support the development ofTeverelix LA as a potential new treatment for prostate cancer, a disease wherenew therapies remain a major medical need in a multi-billion dollar market." For more information contact: Ardana Financial Dynamics Maureen Lindsay (corporate/financial media relations)Tel: + 44 (0) 131 226 8550 Julia Phillips/John Gilbert Tel: +44 (0)20 7831 3113 About Ardana Ardana plc is a pharmaceutical company focused on the discovery, development andmarketing of innovative products to improve human reproductive health, a $25.5billion market. Since its foundation, Ardana has built a broad and balanced portfolio to managerisk and actively pursues product and technology in-licensing and outlicensingto maintain a robust pipeline. Ardana's lead products are summarised below: • Emselex(R), a once a day treatment for the symptoms of overactive bladder syndrome, which Ardana has exclusive UK marketing and promotion rights and is being distributed in collaboration with Novartis UK Limited; • StriantTM SR, a testosterone replacement therapy that has been launched by Ardana through its own sales force in the UK and through marketing partners in certain European countries, as a treatment for men with confirmed hypogonadism; • Teverelix LA, in development for three initial indications (prostate cancer, benign prostatic hyperplasia and endometriosis); • Testosterone Cream, a trans dermal testosterone delivery system in development for the treatment of male hypogonadism, in Phase II trials; • InvicorpTM, an injectable combination drug treatment for erectile dysfunction, for which Ardana has marketing and manufacturing rights in Europe and has been launched in Denmark. • EP01572 a growth hormone secretagogue in late stage development for the diagnosis of growth hormone deficiency In addition, Ardana has a strong portfolio of follow-on products in development.Ardana is listed on the Main Market of the London Stock Exchange. For further information please see www.ardana.co.uk This information is provided by RNS The company news service from the London Stock Exchange