Protherics reports positive data from Phase IIb pre-eclampsia study

The Deep study was designed to investigate whether treatment with a Digoxin Immune Fab (DIF) Digibind, (GlaxoSmithKline) could influence the progression of the disease by neutralizing endogenous digoxin-like factors (EDLFs) which are produced by the placenta and are present at higher levels in some women with pre-eclampsia. The study involved 51 women with severe pre-eclampsia who were in the 24th – 34th week of pregnancy, and for whom delivery of the baby was considered necessary within 72 hours to prevent possible life-threatening complications for the mother or baby. Women received either Digibind or placebo every 6 hours for up to 48 hours. The well-being of both the mother and baby were assessed for up to 24 hours after the birth and also at 6 weeks.

The two primary endpoints of the study were creatinine clearance, a measure of kidney function and the use of antihypertensive medication to lower blood pressure. The Deep study met one of the primary endpoints in that the deterioration in kidney function during the 24-48 hours period of treatment was significantly less (p<0.05) in patients receiving Digibind compared to patients receiving placebo. However, in this study there was no significant difference for the other primary endpoint, the use of antihypertensive drugs. Protherics licensed the intellectual property rights to use DIFs in pre-eclampsia from Glenveigh Pharmaceuticals in December 2006. Protherics paid a $5 million upfront payment to Glenveigh and assumed responsibility for completing the Deep study. Under the terms of the contract, Protherics will now make an additional $5 million milestone payment to Glenveigh. Andrew Heath, CEO of Protherics, said: "The Deep study results provide evidence to support our hypothesis that, through the neutralization of EDLFs, treatment with a DIF might be able to improve the outcome for women with this life threatening condition during pregnancy."