Ardana PLC
21 November 2007
ARDANA ANNOUNCES POSITIVE RESULTS OF A SUPPLEMENTARY STUDY CONFIRMING THE HIGH
DERMAL TOLERABILITY OF TESTOSTERONE CREAM
Edinburgh, UK, 21 November 2007: Ardana plc (LSE:ARA) today announces that in a
recently completed supplementary clinical trial, treatment with Testosterone
Cream for the transdermal delivery of testosterone, has shown that it does not
act as an irritant on skin. Testosterone Cream is in late-stage development for
male hypogonadism.
The study evaluated the dermal tolerability of Testosterone Cream on intact skin
in subjects with healthy skin. Topical application of Testosterone Cream, as
well as negative and positive controls, was undertaken once daily during a
21-day treatment period for an approximate duration of 23 hours per day. 40
male volunteers were included in the study and all subjects received all
treatments i.e. Testosterone Cream, active-ingredient-free vehicle to
Testosterone Cream (placebo), 0.9% sodium chloride in water (negative control)
and 0.1% sodium dodecyl sulphate in water (positive control). Dermal reactions
were clinically assessed on study days 2-22 using an erythema score (range 0 to
4 with 0 being no reaction and 4 being severe erythema reaction with infiltrate
and/or dermal defect e.g. blisters/blebs/erosion).
No statistically significant differences were found between Testosterone Cream,
the placebo and the negative control whereas clear and significant irritation
was seen for the positive control with severe reactions observed in all subjects
by the end of the study.
Several formulations for the delivery of testosterone to hypogonadal men are
marketed globally. Transdermal formulations are increasingly popular as they
avoid the inevitable 'roller-coaster' effect experienced with earlier
formulations such as injectables and implants. However, a significant
disadvantage of the currently available transdermal formulations is the skin
reactions observed at the application site e.g. erythema, acne and dry skin at
an incidence of up to 10%.
Dr Huw Jones, Ardana's CEO said: 'Testosterone Cream represents a very important
near term opportunity for Ardana. The data from this study add low irritatant
potential to the other user-friendly properties of our formulation.'
Ardana has previously reported data from a Phase II dose-finding clinical trial
showing clear evidence of the efficacy and tolerability of Testosterone Cream.
These data facilitated a Phase III pivotal registration study in men with
confirmed hypogonadism (testosterone deficiency), a study that is ongoing in the
USA.
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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