GroPep goes into phase I infertility trial

GroPep (ASX:GRO) has begun to recruit healthy women volunteers into a phase I trial of its infertility drug PV903, targeted to treat recurrent miscarriages caused by an abnormal immune response to the foetus.

The trial has been granted approval from the Royal Adelaide Hospital research ethics committee, and enrolment of the first subjects is due in mid-February, following medical screenings. The results of the trial should be known in late 2006, depending on recruitment rate.

"It's great to be moving into the clinical trials. It is two years since our last human trial and the clinical staff are all very excited," said GroPep CEO Bob Finder.

"Before this project -- and I think in part because of being a man -- I didn't realise the problems associated with recurrent miscarriage, including the emotional issues. This is a potential first-in-class product and we are trying to get results."

The trial, to be conducted at the CMAX, a division of Institute of Drug Technology, based in North Adelaide and the Royal Adelaide Hospital, 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, aged 18 to 45 years and who are currently taking an oral contraceptive pill, will complete the trial. The expected duration of each individual subject's trial participation will be 37 days. 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 immune-based infertility.

According to GroPep, more than 50 per cent 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 responsible 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.

At the conclusion of the phase I trial, GroPep will seek to partner with a larger pharmaceutical or biotechnology company to develop the product through further clinical trials and launch it on the market, in return for upfront and milestone fees and royalty payments.