Aura Renew Acq Regulatory News (ARA)

21 Nov 2007 07:01

Ardana PLC21 November 2007 ARDANA ANNOUNCES POSITIVE PRELIMINARY RESULTS IN A FURTHER PHASE II STUDY OF TEVERELIX LA IN BENIGN PROSTATIC HYPERPLASIA Edinburgh, UK, 21 November 2007: Ardana plc (LSE:ARA) today announces positivepreliminary results from a Phase II study of its key compound, the GnRHantagonist Teverelix Long Acting (LA), which shows that patients may only needto have two maintenance doses per year to treat the symptoms of benign prostatichyperplasia (BPH), a significant potential improvement over current treatments. In previous clinical studies in BPH, Teverelix LA has been shown to decreasetestosterone and subsequently dihydrotestosterone (DHT) in a dose-dependentmanner to levels at the low end of the normal range thereby avoiding a chemicalcastration and its related symptoms. In two earlier Phase II studies in patientswith BPH, Teverelix LA demonstrated an improvement in symptoms of BPH asmeasured by the International Prostate Symptom Score (IPSS). This effect wasshown as early as two weeks after dosing. This latest study is a Phase II, randomised, double-blind, placebo-controlledfollow-on study investigating the effects of Teverelix LA when administered as asecond single subcutaneous injection to patients with BPH who had completed aprior clinical study. The subjects received the same high or low dose ofTeverelix or placebo as they had received in the previous study and weremonitored at four weekly intervals up to 28 weeks after the second injection. Ofthe 84 subjects enrolled in the previous study, 77 were enrolled in this studyand 48 completed the study 28 weeks later. The effects of Teverelix LA on IPSS in this BPH study were marked and sustainedand both clinically and statistically significant. Following study druginjection, the mean IPSS was reduced in all three groups (placebo; low doseTeverelix; high dose Teverelix). At two weeks following the second injection themean changes were -0.9; -2.4 and -2.0 respectively. The maximal effect on IPSSwas observed in all groups 28 weeks after dosing. The mean reductions were -2.6;-4.5 and -5.4 respectively where a reduction in the score by greater than 4 isdeemed to be a highly clinically significant improvement. These changes werestatistically significant in both the active groups (p=0.042 and 0.012respectively). Dr Huw Jones, Ardana's CEO said: "Once again Teverelix LA has shown to deliverimpressive results in the clinic. This repeat dose study shows a clinicallyrelevant improvement in symptoms as measured by the IPSS results. It alsoindicates that BPH sufferers may only need two maintenance doses a year to keeptheir benign prostate disease under control and improve their symptoms." BPH is a common benign disease occurring in men over the age of 50 and increasesin prevalence with age. BPH is characterised by an enlargement of the prostategland, which results in urinary flow problems such as hesitancy, weak orinterrupted stream, urgency and more frequent urination, especially at night. The growth of prostatic tissue is driven by male sex hormones (known asandrogens), primarily testosterone and its more potent metabolitedihydrotestosterone (DHT). Reducing levels of these hormones can reduce thesize and growth of the prostate and thus help improve symptoms. Current treatment options for patients with BPH include watchful waiting,surgical or endoscopic treatment or medical treatment with 5-alpha reductaseinhibitors or alpha blockers. The BPH pharmaceutical market is estimated to beworth US$4.9 billion in 2005 (Source: Wood Mackenzie - Product View April 2006). For more information contact: Ardana Financial DynamicsDr Huw Jones (corporate/financial media relations)Tel: + 44 (0) 131 226 8550 Julia Phillips/Emma Thompson 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. For further information please see www.ardana.co.uk This information is provided by RNS The company news service from the London Stock Exchange