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Reproductive health researchers develop infertility drug technology

Thursday, 16 February 2006

The University of Adelaide's Research Centre for Reproductive Health (RCRH) Reproductive Immunology Group, headed by Associate Professor Sarah Robertson, has developed world-class technology with the potential to assist women suffering recurrent miscarriages.

The active ingredient of the candidate infertility drug PV903 was discovered by scientist Associate Professor Robertson and her clinical colleague Dr Kelton Tremellen at RCRH. The PV903 infertility drug has been developed by commercial partner GroPep Limited and is now undergoing a Phase 1 clinical trial in Adelaide.

Associate Professor Sarah Robertson is eager to take the next step forward in the long and painstaking research process. She said: "The Reproductive Immunology team at RCRH has been working with GroPep on developing the PV903 gel for the past seven years. This world-class reproductive technology could potentially give women suffering the trauma of recurrent miscarriage hope for a successful full-term pregnancy."

About 1-2% of Australian women will suffer from recurrent miscarriage. The medical term for `recurrent miscarriage' is experiencing three or more consecutive miscarriages, a very traumatic experience for any woman.

Associate Professor Sarah Robertson and the Reproductive Immunology Group have developed the therapy to overcome miscarriages caused by a woman's immune response to male transplantation proteins.

"Identifying the right molecule to become the active ingredient in PV903 stemmed from research in the early 1990s in animal trials where we found that factors in semen communicate with the female reproductive tract to prepare for embryo implantation."

The PV903 drug is a recombinant version of the protein that is naturally found in seminal fluid and acts as a conditioning agent thought to prime the female immune system to accept the implantation of an embryo. Many recurrent miscarriages are a result of the mother forming an adverse immune response to the father's antigens present in the fetal tissues, initiating a protective immune response and hence discarding the fetus as `foreign'.

The positive news for women suffering from recurrent miscarriages is that GroPep Limited is now commencing a Phase 1 trial of the PV903 infertility drug and is currently recruiting volunteers to participate.

The trial involves PV903 gel containing recombinant human transforming growth factor-b3 to be vaginally administered to women volunteers in the randomised, double-blind, placebo-controlled study at the Royal Adelaide Hospital-based CMAX facilities.

The clinical trial has two main objectives: one is to confirm the local safety and tolerability of the PV903 gel; and secondly to evaluate the immune response of local cervical immune cell populations and cytokine levels in response to vaginal PV903.

The Phase 1 trial involves administering the PV903 gel directly into the vaginal canal of female volunteers and measuring the vaginal immune cell changes. PV903 can potentially assist to condition the female reproductive tract for pregnancy by building immune tolerance of male transplantation proteins.

The Research Centre for Reproductive Health, through its dedicated experts, focuses on reproductive challenges and the PV903 project is one of several RCRH cutting-edge research pursuits into improving reproductive wellbeing. The Centre has a holistic approach to reproductive health, bringing together basic biomedical, clinical and population health research.

The PV903 clinical trial will run until the end of 2006.

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