Ardana PLC
18 March 2008
ARDANA ANNOUNCES POSITIVE RESULTS FROM A PHASE I STUDY OF TESTOSTERONE CREAM IN
FEMALE SUBJECTS
Edinburgh, UK, 18 March 2008 - Ardana plc (LSE:ARA) the pharmaceutical company
specialising in improving human reproductive health, today announces positive
results of its Testosterone Cream in a Phase I study to evaluate the absorption
of testosterone in women from their unique cream formulation . This Phase I
dose-finding study provided clear evidence of the effectiveness of Ardana's
cream in the transdermal delivery of testosterone in females.
Among other potential uses, Testosterone Cream could be developed as an androgen
supplementation in the management of Female Sexual Dysfunction (FSD) and
specifically Hypoactive Sexual Desire Disorder (HSDD). FSD is believed to be a
relatively common condition, with an estimated prevalence within the general
population of between 19% and 43%1.
The double-blind, randomised, placebo-controlled study was conducted by Dr
Shalendar Bhasin at Boston University in the USA and involved 9 surgically
menopausal women between 18 and 55 years of age. These subjects received in
random order a single application of Testosterone Cream at a dose of 0.2g, 0.4g
and 0.6g, or a placebo cream. Both placebo and active cream were applied to one
upper arm only.
Preliminary analysis of the data show that the three doses, 0.2g, 0.4g, 0.6g,
resulted in an increase in the average concentrations of testosterone over 24
hours of 10.6, 16.2 and 20.0 ng/dL respectively. The maximal concentrations
were 36.6, 47.2 and 48.9 ng/dL respectively.
Ardana's Testosterone Cream, which is also in Phase III clinical development for
hypogonadal men in the USA, is a novel, patented method of delivering
testosterone. Because of its reduced surface area requirement, Ardana's
Testosterone Cream appears to deliver testosterone more efficiently than
existing gel-based testosterone products. The cosmetic-like cream consistency
and low alcohol content contribute to a potentially user-friendly preparation.
The Company recently announced positive results of a differentiation study which
showed that the dermal tolerability of Testosterone Cream was comparable to
normal saline.
Commenting on today's announcement, Dr. Huw Jones, Ardana's CEO, said: 'We are
very encouraged by these preliminary data for our novel Testosterone Cream as a
potentially beneficial product for women. Testosterone is naturally present in
women and restoration of testosterone deficiency has the potential to treat
associated conditions such as Hypoactive Sexual Desire Disorder.'
1.JAMA. 1999 Feb 10;281(6):537-44.
For more information contact:
Ardana plc Financial Dynamics
Dr. Huw Jones. Chief Executive Officer Julia Phillips
Tel: + 44 (0) 131 226 8550 Emma Thompson
Tel: +44 (0)20 7831 3113
Ardana plc (LSE: ARA) is an emerging pharmaceutical company focused on the
discovery, development and marketing of innovative products to improve human
reproductive health, a $25.5 billion market.
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;
• Striant(TM) 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; and
• Invicorp(TM), an injectable combination drug treatment for erectile
dysfunction, for which Ardana has marketing and manufacturing rights in
Europe and has been launched in Denmark.
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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