ARA Aura Renewable Acquisitions Plc

RNS Number:9246R
Ardana PLC
09 April 2008

                          ARDANA ANNOUNCES PRELIMINARY
                 PHASE II REPEAT DOSE RESULTS FOR TEVERELIX LA
                               IN PROSTATE CANCER

Edinburgh, UK: 9 April 2008 :  Ardana plc (LSE:ARA) today announces preliminary
results from a Phase II repeat dose study of its lead development compound, the
GnRH antagonist Teverelix LA (Long-Acting), in patients with prostate cancer
demonstrating testosterone suppression for 28 weeks using an alternative
formulation for the first time.

Previous Phase II studies have confirmed that Teverelix LA can attain and
maintain suppression of testosterone to castration level for up to eight weeks
in patients with prostate cancer.  This new study, using a one month dosing
regime repeated every four weeks up to the twenty fourth week, achieved results
consistent with those previously announced.  The study utilised an alternative
lyophilised formulation offering improvements over the existing powder fill
formulation such as process scalability, product stability and potentially lower
costs of production.

Dr. Huw Jones, Ardana's CEO said: "We are encouraged by these results using an
alternative formulation of Teverelix LA. This is the first time this formulation
has been used in a clinical setting and it has produced good results. The
lyophilised formulation has a number of potential advantages which can be used
in the further development of Teverelix."


Study design

This randomised Phase II study involved forty patients with prostate cancer.  It
was a single arm study where all subjects received initial loading doses of
Teverelix LA and then a single repeat dose on Day 28 and every 28 days
thereafter up to Week 24.  The primary endpoint was the suppression of
testosterone to below castration level ( < 0.5 ng/ml ).

The secondary endpoints were 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:

Testosterone levels at baseline were 3.74 ng/ml.  Suppression in testosterone
was attained within two days of dosing to a median value of 0.40 ng/ml.  Median
testosterone values remained at or below the castration threshold of 0.5 ng/ml
from two weeks following the first injection of Teverelix LA until the end of
the study at week 28.

Mean PSA levels were reduced by approximately 75% within 4 weeks of the first
injection of Teverelix  LA.  The suppression of PSA follows the suppression of
testosterone in patients and also appears to be maintained throughout the 28
week study.

Steady state Teverelix LA plasma levels were achieved within four weeks of
dosing.  The product appears to continue to be well tolerated and there was no
evidence of immunogenicity.

Following review of the all the results to date, including the results of this
repeat dose study using the alternative lyophilised drug product and the success
of the eight week dose regimen announced in September 2007, Ardana is finalising
the prostate cancer development plan for Teverelix LA.

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.
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.

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
Dr Huw Jones, CEO                    (corporate/financial media relations)
Graham Lee, CFO                      Julia Phillips/Emma Thompson
Tel: + 44 (0) 131 226 8550           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 with ticker
symbol ARA-L.


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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