Funding outcome

Preterm birth (PTB) and fetal inflammation (FI) are the major perinatal causes of mortality in children <5 years and of life-long health impairment. In spite of knowing about the peril of PTB for over 70 years, very little has been achieved in terms of diagnosing the risk for the problem and then in treating it. This is due in part to the reluctance of companies and investors to develop products that might be safe for mother but harmful for baby (i.e. the spectre of Thalidomide) and due in part to the fact that there are no 'role models' or 'road maps' showing how to develop commercial success in this field. This major unmet medical need persists in spite of the fact that several models clearly indicate very large markets internationally for products in this field. The proposed research is designed to equip me to become a leader in translating laboratory discovery to useful products to improve women's pregnancy health. In the first part of my training, I will explore the ability of a new antagonist of interleukin-6 (IL-6), HSJ633, to block PTB and FI in pregnant mice. We will test its toxicity, although preliminary studies indicate it is very safe for mother and baby and very effective. HSJ633 will be tested in tandem with the Leukocyte Migration Assay (LMA), a patented diagnostic tool developed by Dr. Olson that predicts which pregnant women will deliver within 7 days, in order to determine if the LMA identifies when HSJ633 is effective in asymptomatic animals. We will then study the efficacy of HSJ633 in human tissues, using fetal membrane explants that we will extract with a tissue punch from placentas donated to us by women with informed consent. With Dr. Chemtob, my career mentor, I will learn considerably more about technology commercialization. I will begin by writing a patent application for HSJ633 and creating strategies for its further intellectual property development and a business plan for its funding and commercialization. I will become involved in all the discussions and decisions within the new joint company, Maternica Therapeutics Inc., formed by Olson and Chemtob, that combines their diagnostics and therapeutics. It is the only such company addressing PTB and FI in the world. This research will translate discovery science into commercially viable products to improve health outcomes for women experiencing preterm birth and their babies.