ARA Aura Renewable Acquisitions Plc

RNS Number:2261D
Ardana PLC
04 September 2007

                     ARDANA ANNOUNCES POSITIVE PRELIMINARY

                       PHASE II RESULTS FOR TEVERELIX LA

                               IN PROSTATE CANCER





Edinburgh, UK: 4 September 2007 :  Ardana plc (LSE:ARA) today announces positive
preliminary results from a Phase II study in patients with prostate cancer
demonstrating a new dose regimen extended to 8 weeks from 4 weeks for its lead
development compound, the GnRH antagonist, Teverelix Long-Acting (LA).



The progression of prostate cancer is driven by male sex hormones (androgens)
such as testosterone.  It is widely accepted that reducing levels of these
hormones in advanced stage disease can help slow the growth of the cancer and
prolong survival.  The production of testosterone can be reduced surgically by
the removal of the testes, or through medicines that affect the production of
testosterone.  Previous Phase II studies have confirmed that Teverelix LA can
attain and maintain suppression of testosterone to castration level for at least
4 weeks in patients with prostate cancer.  This new study has demonstrated a
dosage regime that can extend this to at least 8 weeks.



Dr. Maureen Lindsay, Ardana's CEO said: "We are very encouraged by these
positive and very promising preliminary results, which have identified a dose of
Teverelix LA that extends the suppression of serum testosterone to below
castration level from four weeks to eight weeks or more."



Study design

This randomised Phase II study involved 38 patients with prostate cancer.
Patients were randomly assigned to one of two dose regimens of Teverelix LA.  20
patients received the higher dose and 18 patients received the lower dose.  The
primary endpoint was the duration of suppression of testosterone to below
castration level (< 0.5 ng/ml).



The secondary endpoints were the percentage of patients attaining and
maintaining medical castration, the effects on prostate specific antigen (PSA),
a commonly used serum marker for prostate cancer, the effects on luteinizing
hormone (LH) and the local and systemic tolerability of Teverelix LA.



Preliminary study results:

Mean testosterone levels in the higher and lower dose groups at baseline were
3.71 ng/ml and 4.3 ng/ml respectively. Suppression of testosterone was attained
in both dose groups by Day 3 in 18/20 and 14/18 patients, respectively.



Preliminary data from the higher dose group shows that reduction of testosterone
levels to castration level was attained in 19/20 patients.  For these 19
patients, the duration of castration was between 54 and 147 days with 17
patients being castrated for 8 weeks (56 days) or more.



Also noted in the higher dose group was a rapid effect on PSA levels. At Week 4,
14/19 (74%) of patients had normalised PSA (< 4.0 ng/ml).  Mean PSA levels for
the group were normalised at 8 weeks.



After skin cancer, prostate cancer is the most common type of cancer diagnosed
in men in the USA and is the fourth most common cause of cancer related deaths
in men in northern Europe.  It is estimated1 that the prostate cancer market was
worth over $4.1 billion in 2005 and is expected to grow to $4.2 billion in 2010.



In addition to prostate cancer, Ardana is developing Teverelix LA for two other
indications - benign prostatic hyperplasia (BPH) (Phase II) and endometriosis
(Phase I).



1 Wood Mackenzie dataview.





For more information contact:

Ardana                                     Financial Dynamics
Maureen Lindsay                            (corporate/financial media relations)
Tel: + 44 (0) 131 226 8550                 Julia Phillips/John Gilbert
                                           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 pursue product and technology in-licensing and out-licensing
to maintain a robust pipeline.



Ardana's lead products are summarised below:



  * Emselex(R), a once a day treatment for the symptoms of overactive bladder
    syndrome, for 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;
  * Teverelix LA, in development for three initial indications (prostate
    cancer, benign prostatic hyperplasia and endometriosis);
  * Testosterone Cream, a trans dermal testosterone delivery system in
    development for the treatment of male hypogonadism, in Phase II trials;
  * 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.
  * ARD-07 a growth hormone secretagogue in late stage development for the
    diagnosis of growth hormone deficiency



In addition, Ardana has a strong portfolio of follow-on products in development.
  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
END

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