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) today announces successful results from a Phase II study of the Gonadotrophin Releasing Hormone (GnRH) Antagonist, Teverelix LA (Long Acting) in patients with Benign Prostatic Hyperplasia (BPH).

Teverelix LA demonstrated significant symptomatic improvements, increasing over the time of the study.  In addition, significant improvements were seen in maximum 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, 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.

In previous clinical studies, Teverelix LA has been shown to decrease testosterone 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 received either placebo (40 patients) or Teverelix LA (41 patients) subcutaneously.  As early as two weeks after the dosing of Teverelix LA a statistically significant decrease was observed in prostatic symptoms, as measured by the International Prostate Symptom Score (I-PSS).  At two weeks, mean I-PSS values for placebo and Teverelix LA were decreased by 5.7% and 12.6% respectively (p < 0.004). Symptomatic improvement increased over time and was most pronounced at study completion (16 weeks) at which point I-PSS values for placebo and Teverelix LA were 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  greater than or equal to 25% reduction in symptom score from baseline).  Furthermore, statistically significant improvements were observed in maximum urine flow rate (43%), Quality of 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 few adverse events reported.

Dr. Maureen Lindsay, Chief Executive of Ardana, said:

“We are very encouraged by this study which provides Proof of Concept of Teverelix LA as a potential treatment for BPH, one of three indications for which we are developing the product.  As reported in previous studies, this trial demonstrated that Teverelix LA was well tolerated, without any signs of allergic reactions, and caused a rapid and prolonged improvement of the symptoms of BPH.  These findings suggest that Teverelix LA, administered by subcutaneous injection 2–3 times per year, could be used not only for the improvement of BPH symptoms but also to delay the progression of BPH.   We believe that this compound has considerable potential in the treatment of BPH and in the management of several other diseases.”

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$4.1 billion in 2004 rising to US$5.6 billion in 2008 with a compounded growth rate of 10.4 per cent (Source: Wood Mackenzie’s Product View December 2004).

Further studies are planned for the continued development of Teverelix LA for BPH.  In addition to BPH, Teverelix LA is currently in clinical development for advanced Prostate Cancer and Endometriosis.  Phase II studies which have evaluated Teverelix LA in advanced Prostate Cancer have produced promising efficacy and safety results1.  Teverelix LA is one of a number of important products in the Ardana portfolio which position the company to become a future leader 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”

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