More than 50% of recurrent miscarriages have no apparent explanation* and the market for a drug to correct this is potentially worth up to US$750 million annually.
Following the success of pre-clinical studies performed at McMaster University in Canada, the GroPep drug is on track to be tested in Phase I trials during 2006.
A leading international infertility researcher, Professor David Clark, will present key pre-clinical data on GroPep's infertility drug, PV903, at the 25th Anniversary Meeting of the American Society for Reproductive Immunology in Providence, Rhode Island, 16-18 June 2005.
Professor Clark's research found that administration of a single dose of the GroPep drug PV903 halved the miscarriage rate in a strain of female mice susceptible to the immune rejection of the foetus (a suspected major cause of recurrent miscarriage in women).
Scientists believe that women who suffer from repeated miscarriage have an immune system that attacks the embryo as "foreign" in the same way it would a virus or bacteria. The GroPep drug contains an active ingredient found in semen (called a "cytokine") that is thought to instruct the mother's immune system to "tolerate" the foetus.
Professor Clark, who was President of the American Society for Reproductive Immunology between 1996 and 1998, said: "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. Clinical trials in women with a history of recurrent miscarriage are warranted."
He further noted that: "Past advances in endocrinology have arisen by the discovery and clinical application of defined hormones. These data demonstrate the very real possibility of pharmacotherapy for recurrent miscarriage using a defined agent. Now clinical reproductive immunology may be able to move forward."
GroPep is currently undertaking additional pre-clinical work in preparation for a Phase 1 clinical trial. Studies aimed at optimising the PV903 formulation as well as defining clinical endpoints will underpin the clinical program planned to commence in Adelaide in 2006.
GroPep advised on December 20, 2004 that it intends to proceed with the PV903 project towards a Phase 1 clinical trial. This latest data confirms that position.
What is Recurrent Miscarriage?
A considerable proportion of cases of recurrent miscarriage occur in couples where the mother develops an adverse immune response to the father's antigens or proteins present in the foetus. It is estimated that, in the United States alone, there are 170,000 women who seek treatment for this traumatic condition every year. GroPep's product, PV903, is a recombinant version of a protein which is naturally found in semen. It is thought that this protein is responsible for instructing the mother's immune system to tolerate the implanting embryo, rather than identifying it as a foreign object and subsequently rejecting it. Market research commissioned by GroPep has indicated that if successful, sales of US$750 million per annum are possible for this product.
About GroPep
GroPep is a world leader in the development, manufacture and commercialisation of biologically active proteins for cell culture and biomedical research. The Company has an active biopharmaceutical development program that establishes proof of concept for products in humans and partners the later stages of product development and marketing with major pharmaceutical companies. GroPep is listed on the Australian Stock Exchange Limited (ASX code: GRO).
Further Information:
Mr Tony Mitchell
Chief Financial Officer/Investor Relations
Ph: +61 8 8354 7700
investorrelations@gropep.com.au
* The American College of Obstetricians and Gynecologists