GroPep releases infertility data

Key pre-clinical data on GroPep's (ASX:GRO) infertility drug, PV903, showing a halving of the miscarriage rate in a strain of female mice susceptible to the immune rejection of the foetus, will be presented at a reproductive immunology meeting this week in the US.

International infertility researcher, Prof David Clark, will present the data at the 25th Anniversary Meeting of the American Society for Reproductive Immunology in Providence, Rhode Island on June 16-18.

"[Based] in Canada, Prof David Clark, has been able to produce an animal model of abortion, if you like," said GroPep CFO Tony Mitchell. "And he's been able to show, with that model, some significant improvement as a result of administering our drug product."

Immune rejection of the foetus, where the immune system attacks the embryo as 'foreign' in the same way it would a virus or bacteria, is a suspected major cause of recurrent miscarriage in women.

GroPep's PV903 drug is a recombinant version of a protein cytokine naturally found in semen which is thought to instruct the mother's immune system to tolerate the implanting embryo rather than identifying it as a foreign object and subsequently rejecting it.

"This is the first time a cytokine has been shown to positively affect reproductive outcome in an animal model of reproductive failure that shares many pathological features with recurrent miscarriage in humans," said Clark in a statement.

GroPep is currently undertaking additional pre-clinical work to optimise the PV903 formulation and define clinical endpoints in preparation for a Phase I clinical trial of PV903 to begin in Adelaide in 2006.

"Ultimately Phase II or Phase III trials in this area are likely to require pregnancy outcomes. But what we're looking at for the Phase I trial is whether there can be some other surrogate markers for action, rather than go into a pregnancy outcome which is clearly not feasible or possible in a Phase I," Mitchell said.