Aura Renew Acq Regulatory News (ARA)

9 Apr 2008 07:00

Ardana PLC09 April 2008 ARDANA ANNOUNCES PRELIMINARY PHASE II REPEAT DOSE RESULTS FOR TEVERELIX LA IN PROSTATE CANCER Edinburgh, UK: 9 April 2008 : Ardana plc (LSE:ARA) today announces preliminaryresults from a Phase II repeat dose study of its lead development compound, theGnRH antagonist Teverelix LA (Long-Acting), in patients with prostate cancerdemonstrating testosterone suppression for 28 weeks using an alternativeformulation for the first time. Previous Phase II studies have confirmed that Teverelix LA can attain andmaintain suppression of testosterone to castration level for up to eight weeksin patients with prostate cancer. This new study, using a one month dosingregime repeated every four weeks up to the twenty fourth week, achieved resultsconsistent with those previously announced. The study utilised an alternativelyophilised formulation offering improvements over the existing powder fillformulation such as process scalability, product stability and potentially lowercosts of production. Dr. Huw Jones, Ardana's CEO said: "We are encouraged by these results using analternative formulation of Teverelix LA. This is the first time this formulationhas been used in a clinical setting and it has produced good results. Thelyophilised formulation has a number of potential advantages which can be usedin the further development of Teverelix." Study design This randomised Phase II study involved forty patients with prostate cancer. Itwas a single arm study where all subjects received initial loading doses ofTeverelix LA and then a single repeat dose on Day 28 and every 28 daysthereafter up to Week 24. The primary endpoint was the suppression oftestosterone to below castration level ( < 0.5 ng/ml ). The secondary endpoints were the effects on prostate specific antigen (PSA), acommonly used serum marker for prostate cancer, the effects on luteinizinghormone (LH) and the local and systemic tolerability of Teverelix LA. Preliminary study results: Testosterone levels at baseline were 3.74 ng/ml. Suppression in testosteronewas attained within two days of dosing to a median value of 0.40 ng/ml. Mediantestosterone values remained at or below the castration threshold of 0.5 ng/mlfrom two weeks following the first injection of Teverelix LA until the end ofthe study at week 28. Mean PSA levels were reduced by approximately 75% within 4 weeks of the firstinjection of Teverelix LA. The suppression of PSA follows the suppression oftestosterone in patients and also appears to be maintained throughout the 28week study. Steady state Teverelix LA plasma levels were achieved within four weeks ofdosing. The product appears to continue to be well tolerated and there was noevidence of immunogenicity. Following review of the all the results to date, including the results of thisrepeat dose study using the alternative lyophilised drug product and the successof the eight week dose regimen announced in September 2007, Ardana is finalisingthe prostate cancer development plan for Teverelix LA. After skin cancer, prostate cancer is the most common type of cancer diagnosedin men in the USA and is the fourth most common cause of cancer related deathsin men in northern Europe. It is estimated1 that the prostate cancer market wasworth over $4.1 billion in 2005 and is expected to grow to $4.2 billion in 2010.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 stage disease can help slow the growth of the cancer andprolong survival. The production of testosterone can be reduced surgically bythe removal of the testes, or through medicines that affect the production oftestosterone. In addition to prostate cancer, Ardana is developing Teverelix LA for two otherindications - benign prostatic hyperplasia (BPH) (Phase II) and endometriosis(Phase I). 1 Wood Mackenzie dataview. For more information contact: Ardana Financial DynamicsDr Huw Jones, CEO (corporate/financial media relations)Graham Lee, CFO Julia Phillips/Emma ThompsonTel: + 44 (0) 131 226 8550 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: • Teverelix LA, in development for three initial indications (prostate cancer, benign prostatic hyperplasia and endometriosis); • ARD-0705 a growth hormone secretagogue in Phase III for the diagnosis of growth hormone deficiency in adults • Testosterone Cream, a transdermal testosterone delivery system in development for the treatment of male hypogonadism, in Phase III trials; • 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; • 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. In addition, Ardana has a strong portfolio of follow-on products in research.Ardana is listed on the Main Market of the London Stock Exchange with tickersymbol ARA-L. For further information please see www.ardana.co.uk This information is provided by RNS The company news service from the London Stock Exchange