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GroPep starts Phase 1 infertility trial

sponsible for instructing the mother's immune system to tolerate the implanting embryo. Preclinical studies previously reported by GroPep have shown that a single intravaginal dose of PV903 halves the miscarriage rate in a mouse model of reproductive failure that shares many features with recurrent miscarriage in humans. A Clinical Research Study conducted in the last six months has enabled GroPep to identify and measure a range of immune cells from the cervix of healthy women volunteers. Changes in these cells after the introduction of PV903 are expected to indicate whether the treatment is effective. GroPep CEO Mr Bob Finder said he was delighted at the commencement of the PV903 clinical trial. He further noted, "This trial represents the culmination of several years work by GroPep and our collaborators to understand the role of PV903 in immune-based infertility, undertake toxicology studies and develop a stable gel-based formulation."

"As this is a potential first-in-class product, GroPep has had to develop new methods to measure the effect of PV903 on the immune system. We are now in a position to initiate the clinical phase of this program, which has the potential to offer the first drug treatment for recurrent miscarriage", Mr Finder added. The following information is provided regarding the trial. Name of Trial

A Phase Ia, randomised, double-blind, placebo-controlled, sequential single-dose escalating trial in healthy adult female volunteers to evaluate the short-term safety, tolerability and preliminary immune activity of vaginally administered PV903 gel.


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Contact: Mr Tony Mitchell
61-283-547-700
Research Australia
9-Jan-2006


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