SYDNEY, Australia ¿ GroPep Ltd. intends to start Phase I trials of a treatment for recurrent miscarriage next year based on the use of transforming growth factor-beta.

GroPep, of Adelaide, recently licensed the rights to the use of TGF-beta plus considerable information about the safety of the product from OSI Pharmaceuticals Inc., of New York, earlier this year in return for an undisclosed package, including fees, milestone payments and royalties, and is now reformulating the growth factor for use in a human womb.

GroPep¿s business development manager, Gregory Ross-Smith, said that further animal trials to establish the safety of the product and the time required for the reformulation meant that the first trial would not occur until near the end of 2002.

But when it does occur, the Phase I trial would probably be in six to 12 individuals recruited in Adelaide, he said.

TGF-beta is a naturally occurring protein found in high concentrations in semen and is responsible for instructing the mother¿s immune system to tolerate what would otherwise be foreign fetal proteins originating from the father. In recurrent miscarriages this system breaks down and the fetus is rejected by the mother in much the same way foreign tissue can be rejected after a transplant operation.

Ross-Smith said researchers at the University of Adelaide¿s Department of Obstetrics and Gynecology, Sarah Robertson and obstetrician Kelton Tremellen, have investigated the role of TGF-beta in recurrent miscarriages, and believe that there is a way to treat that condition.

However, they did not have the rights to the growth factor so GroPep had to go looking for a company with the rights it required and then do a deal. OSI also is using TGF-beta but in different lines of research, including work with Novartis AG.

GroPep also has done considerable work with TGF-beta and the reproductive system of mice.

¿Investigations in mice have been positive and preliminary results from clinical studies have so far confirmed a similar response in humans,¿ Ross-Smith said.

He also commented that he believed the safety information provided by OSI had saved GroPep considerable costs and more than two years in development time.