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Positive clinical trial results for contraceptive spray

Australian drug delivery company, Acrux, has posted positive results from its phase 1 clinical studies using two contraceptive skin sprays, each containing a progestin and an estrogen

Australian drug delivery company, Acrux, has posted positive results from its phase 1 clinical studies using two contraceptive skin sprays, each containing a progestin and an estrogen.

The first phase I, pharmacokinetic study, investigated the delivery of a formulation combining Nestorone and the synthetic estrogen, ethinyl estradiol. A single dose of the combination formulation was applied to the forearm of healthy volunteers.

The results showed that the dosing of the contraceptive spray provided effective delivery of both contraceptive agents, with blood concentrations of Nestorone and ethinyl estradiol in the target range expected to provide effective contraception. The spray was well tolerated, with no serious adverse events recorded.

Acrux CEO Richard Treagus said: "This is the first time that the Acrux MDTS spray technology has effectively delivered a formulation containing a combination of two drugs. We are particularly pleased that our transdermal spray has been successful with Ethinyl Estradiol, as this is the active pharmaceutical compound in approximately three out of every four oral contraceptive tablets."

Acrux plans to proceed with a multi-dose phase 1 study in H2 2007. The study will be designed to demonstrate that therapeutic blood levels of the combination contraceptive are effectively maintained with once daily dosing.

The second study was a phase I, pharmacokinetic study, investigating the delivery of a formulation combining Nestorone and the natural estrogen, Estradiol. The results showed that the dosing of the contraceptive spray provided effective delivery of Nestorone, with blood concentrations in the target range that is expected to provide effective contraception. The spray was also well tolerated, with no serious adverse events recorded.

Analysis of blood concentrations of estradiol was inconclusive, due to interaction with background levels of estradiol in the study population. Acrux has established experience with estradiol in hormone therapy, with its lead product containing estradiol currently in pre-registration in the USA. This, along with in-vitro results from a number of formulations containing estradiol, gives the company confidence that it can deliver this novel combination contraceptive through the skin effectively. Acrux is planning a further phase 1 study in H2 2007 in order to confirm these predictions.

Acrux had cash reserves of USD 19m and a cash outflow of USD 8.3m in FY 2005/06. The company's priority is to grow revenue from new and existing licences, while research and commercialisation are scalable at fixed cost. Acrux is targeting revenue growth to drive profitability in 2008.

The company has licences with the following companies: Organon (worth up to USD 16m per product plus royalties), VIVUS (worth up to USD 8.5m in milestones plus royalties) and Elanco (worth up to USD 7.2m in milestones plus royalties).

11th July 2007

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