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 positive preliminary results from a Phase II study of its key compound, the GnRH antagonist Teverelix Long Acting (LA), which shows that patients may only need to have two maintenance doses per year to treat the symptoms of benign prostatic hyperplasia (BPH), a significant potential improvement over current treatments.

In previous clinical studies in BPH, Teverelix LA has been shown to decrease testosterone and subsequently dihydrotestosterone (DHT) in a dose-dependent manner to levels at the low end of the normal range thereby avoiding a chemical castration and its related symptoms. In two earlier Phase II studies in patients with BPH, Teverelix LA demonstrated an improvement in symptoms of BPH as measured by the International Prostate Symptom Score (IPSS).  This effect was shown as early as two weeks after dosing.

This latest study is a Phase II, randomised, double-blind, placebo-controlled follow-on study investigating the effects of Teverelix LA when administered as a second single subcutaneous injection to patients with BPH who had completed a prior clinical study.  The subjects received the same high or low dose of Teverelix or placebo as they had received in the previous study and were monitored at four weekly intervals up to 28 weeks after the second injection. Of the 84 subjects enrolled in the previous study, 77 were enrolled in this study and 48 completed the study 28 weeks later.

The effects of Teverelix LA on IPSS in this BPH study were marked and sustained and both clinically and statistically significant.  Following study drug injection, the mean IPSS was reduced in all three groups (placebo; low dose Teverelix; high dose Teverelix). At two weeks following the second injection the mean changes were -0.9; -2.4 and -2.0 respectively. The maximal effect on IPSS was 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 is deemed to be a highly clinically significant improvement. These changes were statistically significant in both the active groups (p=0.042 and 0.012 respectively). 

Dr Huw Jones, Ardana’s CEO said: “Once again Teverelix LA has shown to deliver impressive results in the clinic. This repeat dose study shows a clinically relevant improvement in symptoms as measured by the IPSS results.  It also indicates that BPH sufferers may only need two maintenance doses a year to keep their benign prostate disease under control and improve their symptoms.”

BPH is a common benign disease occurring in men over the age of 50 and increases in prevalence with age.  BPH is characterised by an enlargement of the prostate gland, which results in urinary flow problems such as hesitancy, weak or interrupted stream, urgency and more frequent urination, especially at night.

The growth of prostatic tissue is driven by male sex hormones (known as androgens), primarily testosterone and its more potent metabolite dihydrotestosterone (DHT).  Reducing levels of these hormones can reduce the size 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 reductase inhibitors or alpha blockers.  The BPH pharmaceutical market is estimated to be worth US$4.9 billion in 2005 (Source: Wood Mackenzie - Product View April 2006).

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