Aura Renew Acq Regulatory News (ARA)

26 May 2005 07:01

Ardana PLC26 May 2005 ARDANA ANNOUNCES SUCCESSFUL RESULTS IN A PHASE II STUDY OF TEVERELIX LA IN BENIGN PROSTATIC HYPERPLASIA Edinburgh, UK, 26 May 2005; Ardana plc (LSE:ARA) the emerging pharmaceuticalcompany focused on improving human reproductive health, today announcessuccessful results from a Phase II study of the Gonadotrophin Releasing Hormone(GnRH) Antagonist, Teverelix LA (Long Acting) in patients with Benign ProstaticHyperplasia (BPH). Teverelix LA demonstrated significant symptomatic improvements, increasing overthe time of the study. In addition, significant improvements were seen inmaximum urine flow rates, prostate size and patient's quality of life. BPH is a common benign disease occurring in men over the age of 50, andincreases in prevalence with age. BPH is characterised by an enlargement of theprostate gland, which results in urinary flow problems such as hesitancy, weakor interrupted 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. In previous clinical studies, Teverelix LA has been shown to decreasetestosterone and subsequently DHT in a dose-dependent manner. Therefore,Teverelix LA can reduce testosterone levels to the low end of the normal range,avoiding a chemical castration and its related symptoms. In this Phase II randomised, double-blind study, 81 patients with BPH receivedeither placebo (40 patients) or Teverelix LA (41 patients) subcutaneously. Asearly as two weeks after the dosing of Teverelix LA a statistically significantdecrease was observed in prostatic symptoms, as measured by the InternationalProstate Symptom Score (I-PSS). At two weeks, mean I-PSS values for placebo andTeverelix LA were decreased by 5.7% and 12.6% respectively (p < 0.004).Symptomatic improvement increased over time and was most pronounced at studycompletion (16 weeks) at which point I-PSS values for placebo and Teverelix LAwere decreased by 7.4% and 33.9% respectively (p < 0.001). Seventy six (76%)per cent of patients on Teverelix LA were classified as responders (defined as(3) 25% reduction in symptom score from baseline). Furthermore, statisticallysignificant improvements were observed in maximum urine flow rate (43%), Qualityof Life (32.8%) and prostate size (11.5 % reduction) when compared to baseline.The study showed that Teverelix LA continues to be well tolerated with fewadverse events reported. Dr. Maureen Lindsay, Chief Executive of Ardana, said: "We are very encouraged by this study which provides Proof of Concept ofTeverelix LA as a potential treatment for BPH, one of three indications forwhich we are developing the product. As reported in previous studies, thistrial demonstrated that Teverelix LA was well tolerated, without any signs ofallergic reactions, and caused a rapid and prolonged improvement of the symptomsof BPH. These findings suggest that Teverelix LA, administered by subcutaneousinjection 2-3 times per year, could be used not only for the improvement of BPHsymptoms but also to delay the progression of BPH. We believe that thiscompound has considerable potential in the treatment of BPH and in themanagement of several other diseases." 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$4.1 billion in 2004 rising to US$5.6 billion in 2008 with a compoundedgrowth rate of 10.4 per cent (Source: Wood Mackenzie's Product View December2004). Further studies are planned for the continued development of Teverelix LA forBPH. In addition to BPH, Teverelix LA is currently in clinical development foradvanced Prostate Cancer and Endometriosis. Phase II studies which haveevaluated Teverelix LA in advanced Prostate Cancer have produced promisingefficacy and safety results(1). Teverelix LA is one of a number of importantproducts in the Ardana portfolio which position the company to become a futureleader in reproductive health. (1) Please see press release issued 12 May 2005 re "Successful Results in Second Phase II study of Teverelix LA in Prostate Cancer" For more information contact: Ardana Financial Dynamics Maureen Lindsay (corporate/financial media relations) Tel: + 44 (0) 131 226 8550 Julia Phillips/Davina Langdale Tel: +44 (0)20 7831 3113 NB Public Relations (trade/technical media relations) Nicki Brimicombe Tel: + 44 (0)1883 732353 About Ardana Ardana plc is a pharmaceutical company focused on the discovery, development andmarketing of innovative products to improve human reproductive health, a $23.8billion market. Since its foundation, Ardana has maintained a broad and balanced portfolio tomanage risk and actively pursues product and technology in-licensing andoutlicensing to maintain a robust pipeline. Ardana's four lead products are summarised below: • Striant(TM) SR, a testosterone replacement therapy that has already been launched by Ardana through its own sales force in the UK as a treatment for men with hypogonadism and for which Ardana has marketing rights in Europe; • Teverelix LA, in development for three initial indications (prostate cancer, BPH and endometriosis); • Testo Bi-gel, a trans dermal testosterone delivery system in development for the treatment of male hypogonadism, shortly to enter Phase II trials; • Invicorp, an injectable combination drug treatment for erectile dysfunction, for which Ardana has marketing and manufacturing rights in Europe. In addition, Ardana has a strong portfolio of follow-on products in development.Ardana completed its IPO on the London Stock Exchange in March 2005 raising£21 million. For further information please see www.ardana.co.uk This information is provided by RNS The company news service from the London Stock Exchange