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GroPep starts Phase 1 infertility trial

GroPep's program - to develop a treatment for a condition that potentially causes 50% of all miscarriages - reached a major milestone today with commencement of recruitment of healthy women volunteers into a Phase 1 trial of its infertility drug, PV903.

The drug is targeted to treat recurrent miscarriages caused by an abnormal immune response to the foetus a condition for which there is no current treatment.

The market for a drug to treat this condition is estimated to be up to US$750 million annually.

Listed biopharmaceutical company GroPep Limited (ASX:GRO) announced today that it will commence a Phase 1 trial of its infertility drug PV903. The trial, which will be conducted under the Therapeutic Goods Administration Clinical Trial Notification scheme, was approved by the Royal Adelaide Hospital Research Ethics Committee.

Recruitment will begin immediately to allow medical screening and enrolment of the first cohort of subjects in mid-February 2006. The results of the trial should be known in late 2006, depending on recruitment rate.

The trial, conducted at the CMAX Adelaide-based facilities, involves healthy female volunteers each receiving a single administration of PV903 gel (or placebo) as they are enrolled sequentially into three groups with the PV903 dose escalating between groups. A total of 36 volunteers will complete the trial. The objectives of the trial are to evaluate the safety and tolerability of vaginally administered PV903 gel, and to determine whether PV903 has effects on vaginal immune cells in a manner consistent with its proposed role in treating immunebased infertility.

Over 50% of miscarriages have no apparent explanation and some scientists believe that women who suffer from repeated miscarriage have an immune system that attacks the embryo as "foreign". PV903 is a recombinant version of a protein that is naturally found in semen and thought to be re
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Contact: Mr Tony Mitchell
61-283-547-700
Research Australia
9-Jan-2006


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