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Ardana Plc Announces Positive Phase 1 Results


3/18/2008 12:07:01 PM

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 Dr. Huw Jones. Chief Executive Officer Tel: + 44 (0) 131 226 8550

Financial Dynamics Julia Phillips Emma Thompson Tel: +44 (0)20 7831 3113


Read at BioSpace.com


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