Acrux reports on testosterone product trials

Specialty pharmaceutical company Acrux (ASX:ACR) has reported positive results from two more clinical studies of its Testosterone MD-Lotion treatment for testosterone deficiency in men.

Both studies were conducted at the Centre for Clinical Studies, Melbourne, with Prof Susan Davis supervising as principal investigator.

The studies compared blood levels of testosterone in healthy, pre-menopausal women, aged 18 to 45 years.

While the lotion being tested is for men, conducting the trial is women "is a clever way of doing the study quicker," said Acrux CFO Jon Pilcher. Men already have high levels of testosterone, so to study blood levels in men after treatment, their testosterone would need to be suppressed, making it hard to recruit volunteers, said Pilcher.

"Women don't have these existing testosterone levels, so you don't have to do the suppressions. Making it much easier to recruit them for the study," said Pilcher.

All future trials, however, will be conducted in men.

One study compared two different formulations of Testosterone MD Lotion, the other study compared two different application sites. The results of the first study showed that both formulations provided similar blood levels, providing options for continued development of either formulation.

In the second study, there was a significant difference in absorption between the two different application sites, providing important information for the design of the remaining clinical studies. While declining to reveal the specific application site, Pilcher said: "We're very pleased that there was a significant difference."

"One of the things we're trying to do with this product is reduce the surface area that it has to be applied over. The better it goes across the skin the smaller the surface area we have to apply it to," he said.

The lotion was well tolerated in both studies, with no application site reactions noted. No serious adverse events, and some mild or moderate adverse events, were recorded.

"The dosing was done very early in the morning, so a lot of the events were simply caused by the women being very tired," said Pilcher.

Acrux is planning to file the New Drug Application for Testosterone MD Lotion in mid 2008, and has three more studies to complete, one trial in male volunteers and two larger trials in patient populations, said Pilcher.

"The remaining trials suit our expertise and require moderate investment, so in line with our financial plans we intend to complete them ourselves before choosing the best option for sales and marketing," said Acrux CEO and managing director Dr Igor Gonda in a statement.