ARA Aura Renewable Acquisitions Plc

RNS Number:1529I
Ardana PLC
21 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 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).





For more information contact:


Ardana                               Financial Dynamics
Dr 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 and
marketing of innovative products to improve human reproductive health, a $25.5
billion market.



Since its foundation, Ardana has built a broad and balanced portfolio to manage
risk and actively pursues product and technology in-licensing and outlicensing
to 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
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