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.

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