ARDANA RELEASES PRELIMINARY RESULTS OF TESTOSTERONE CREAM TRIAL

Ardana has announced preliminary results of a Phase II study of its testosterone cream in hypogonadal men. A preliminary analysis of the data confirms that the cream is effective in restoring testosterone levels to the normal range when administered as a single dose of 2.25 or 4.5 g on a daily basis.

The open-label, randomized study involved 16 patients diagnosed with male hypogonadism or testosterone deficiency. Over a period of 28 days, two groups were randomized to receive a daily single application of the cream. Serum testosterone concentrations at steady state were measured over a period of 24 hours at the end of the study at day 28.

Preliminary data shows that 80 percent of patients on the low dose had average testosterone concentrations within normal range at day 28. The average concentration of testosterone for this group at day 28 was 4.74 ng/ml (normal range 3-10 ng/ml). This preliminary analysis indicates that only a small proportion of patients may require an upward dose titration to adequately replace testosterone to within the normal range. Furthermore, the data indicates that the low dose should meet efficacy criteria.

Ardana's testosterone cream appears to deliver testosterone more efficiently than existing gel-based testosterone products, and it also has a low alcohol content, according to the company. Alternative therapies for male hypogonadism include injectable formulations of testosterone, oral preparations, transdermal patches, topical gels and subcutaneous implants.