This trial, which is expected to start in July, 2008 is the second Phase I trial for this product. The first Phase I trial was conducted in India, and results showed the product to be well tolerated with the potential to be dosed once monthly thereby providing an improved dosing regime for patients.
The second Phase I study, which will take place at Anapharm’s, the contract research organization, clinical research facilities in Canada, is a randomized double-blind, placebo-controlled trial. The study is designed to assess the safety and tolerability of ErepoXen, formulated using Lipoxen’s proprietary PolyXen technology, at single doses of 1.0ug/kg, 2.0ug/kg, 4.0ug/kg or 6.0ug/kg.
The trial will involve 32 healthy adult males, 24 of whom will receive the product candidate while eight will receive placebo, via subcutaneous injection. It is anticipated the results of this Phase I clinical trial will be available in the fourth quarter of 2008.