Melbourne, Australia, 2 May 2007: Drug delivery company Acrux (ASX: ACR), announced today that it has successfully completed enrolment of 40 patients in the final Phase 2 trial of its unique testosterone lotion for treatment of testosterone deficiency in men. Preliminary results of the trial are expected to be available in July 2007.
The trial is being conducted at 8 clinics in the USA. The aim is to demonstrate that discreet daily application of Acrux's user-friendly lotion to the armpits raises the level of testosterone into the normal range. This is being undertaken by measuring testosterone levels in the blood and does not require the measurement of clinical symptoms.
A Phase 3 trial in 150-200 patients will be required before marketing applications can be made to regulatory authorities. This trial is expected to commence in early 2008 and will again require the measurement of testosterone levels in the blood, rather than the impact on clinical symptoms.
Acrux CEO Richard Treagus commented "Our Phase 2 study will complete on time and the remaining requirements to get this compelling product on the market are relatively straightforward. Confidence in the value of our Testosterone MD-Lotion has been further boosted by the interest shown in this product by potential licensing partners."
About Acrux's Testosterone MD-Lotion
Market research in the USA amongst both patients and prescribers that use current testosterone replacement products, including gels and injections, showed a strong preference by the patients for daily application of Acrux's lotion over the existing products. The Acrux product will apply a precise dose of quick-drying lotion to the armpit once daily, via a convenient and ergonomic "no-touch" applicator.
The leading gel is applied each day as a 5 gram dose by hand to the shoulders, upper
arms and/or abdomen. It takes longer to dry and patients are advised
Contact: Richard Treagus