01 02 08   St. Louis Post-Dispatch article by Rachel Melcer

Obstetrician Jodie Rai is tired of seeing the number of babies born too soon increase year after year in this country, with little that she and her colleagues can do about it.

So she has partnered with researcher Robert Kokenyesi to form a local company and develop a test that might be able to predict, for the first time, which women are likely to deliver at less than 37 weeks of pregnancy, the definition of a pre-term birth. The company, Cervimark LLC, is based at the Nidus Center for Scientific Enterprise incubator in Creve Coeur.

If Cervimark succeeds, its test would allow doctors to intervene in the limited ways available to them — by moving rural patients closer to hospitals with neonatal intensive care units, for example, or administering drugs to the mother that can speed her baby's respiratory development.

Perhaps more importantly, Rai said, the test would identify a group of patients who could be tapped as volunteers for clinical trials in the development of new and better treatments. While doctors know that women who carry multiple babies, those who have certain physical reproductive problems, or those who smoke are at greater risk of pre-term delivery than the general population, a large number of early births occur with no apparent precursor.

"Now, by the time you diagnose (a pre-term birth), the woman is already in labor, and you can't do much. It's like treating a heart problem after there's been an attack," Rai said.

The situation also leaves few options for drug developers, who need to identify patients on the path to an early birth to test whether a treatment is effective.

The March of Dimes, a nonprofit organization that funds a national awareness campaign as well as medical research in pre-term births, is pushing for increased federal funding and government action. It estimates that pre-term births in 2005 cost the nation more than $26.2 billion in medical and educational costs, plus lost productivity, because babies born early are at high risk of respiratory distress syndrome, feeding difficulties, hypothermia, jaundice, and delayed brain development.

"Prematurity is a major problem in our country. It's the most important cause of infant mortality. So it would be extremely good if we could predict which women ... were highly likely or predisposed to deliver prematurely," said Dr. Alan Fleischman, senior vice president and medical director of the March of Dimes Foundation.

Without seeing Cervimark's approach, he reserved judgment on its likelihood for success. To become a standard of care for physicians, any test would need to succeed in a prospective study involving perhaps 50,000 pregnant women — and that can take a lot of funding and time to complete, he said.

Cervimark's technology involves collecting samples of patients' vaginal secretions to test for the presence of certain biomarkers that were identified by Kokenyesi, who is the firm's chief scientific officer. These biomarkers appear to indicate whether a woman's cervix is softening prematurely, a key indicator that she is headed for early labor.

Rai developed the method for finding these biomarkers in fluid, rather than through a more invasive method that couldn't be used on a pregnant woman. Along with colleagues at Washington University and Missouri Baptist Hospital, Rai also is collecting samples from patients for Cervimark's trials.

The firm initially studied 60 patients, then used that data to apply for and win a $105,000 grant from the federal National Institutes of Health. With that money, the company is beginning a 200-patient, six-month trial that will generate sufficient data for peer-reviewed scientific publication. It also could lead to a second round of federal funding worth about $1 million, Rai said.

Cervimark also is meeting with private and institutional investors in hopes of raising another $1.5 million.

In all, those funds should allow Cervimark to develop a prototype test within three years, assuming the trials are successful, Kokenyesi said. Ideally, it would be used once or twice for screening in every pregnancy.

"Cervimark would be supplying a piece that is missing now. It could open the floodgates" for current treatments to be applied and new ones to be developed, he said.

Researchers elsewhere are using biomarkers, genetic testing and other methods to find a predictive test for pre-term birth. Some believe the answer lies in administering routine internal ultrasound tests, or more carefully analyzing a patient's family history and genetic background. Other scientists are using biomarkers to identify inflammation in pregnancy as an indicator, as opposed to Cervimark's approach of checking for changes in connective tissue of the cervix.

In the end, "it may well be we have to look at all of these approaches" as a combined solution, Fleischman said. "There is no question that we need new approaches. There's no question that prematurity is increasing and our ability to predict it isn't getting any better. ... It's the most serious problem for America's children."

Born too soon

In Missouri ...
The rate of infants born pre-term increased by 13 percent between 1994 and 2004.
In 2004, there were 10,075 pre-term births, or 13 percent of total live births.
In Illinois ...
The rate of infants born pre-term increased by 11 percent between 1994 and 2004.
In 2004, there were 23,553 pre-term births, or 13.1 percent of total live births.

Source: www.marchofdimes.com/peristats

Pre-term birth in the U.S. by the numbers

1: The rank of pre-term birth among causes of death in the first month of life
12.8: The percentage of births in the United States last year that occurred at less than 37 weeks of pregnancy
35: The percentage increase in the rate of pre-term births in the U.S. between 1981 and 2005
543,000: The number of babies born pre-term last year
$26.2 billion: The estimated 2005 cost of pre-term births in the U.S. in medical and educational costs plus lost productivity

Sources: National Center for Health Statistics, March of Dimes

Published in the Business section of the St. Louis Post-Dispatch on Wednesday, January 2, 2008.
© 2008, St. Louis Post-Dispatch. All rights reserved. Reprinted with permission.
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