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Trial to Test Engineered DNA Therapy for Preeclampsia

ATryn filling syringe

(rEVO Biologics)

31 March 2014. The biopharmaceutical company rEVO Biologics in Framingham, Massachusetts is starting a clinical trial of its drug ATryn to treat women in mid-pregnancy with preeclampsia. The company says the U.S. Food and Drug Administration gave its approval for the trial to begin.

Preeclampsia is a life-threatening condition resulting from a sudden rise in blood pressure in a pregnant woman, affecting blood flow to the placenta. The only known cure for preeclampsia is delivery of the baby, which in some cases can be dangerous for the baby as well as the mother. The earlier in the pregnancy preeclampsia occurs, the riskier to outcomes for both mother and baby. The Preeclampsia Foundation says the condition occurs in 5 to 8 percent of all pregnancies.

The trial aims to test rEVO’s ATryn as a treatment for early-onset preeclampsia, in the 24 to 28th week of pregnancy. ATryn is an engineered antithrombin protein designed to prevent blood-clot related conditions caused by hereditary deficiencies that restrict these conditions from occurring. The drug is already approved to prevent symptoms such as coughing up blood and fainting experienced by patients with an antithrombin deficiency.

The PRESERVE-1 trial — short for Pharmacokinetics, Safety and Efficacy Study of Recombinant Antithrombin Versus Placebo in Preterm Preeclampsia — is a late-stage test of ATryn’s ability to prolong the pregnancy, allowing the baby to further develop and improve the outcomes for both mother and child. The trial plans to enroll 120 patients, with  Yale New Haven Hospital in Connecticut enlisted as the first site.

The trial will test ATryn’s safety, effectiveness, and activity in the body against a placebo. The main indicator of effectiveness is gestational age — time between conception and birth — but the researchers will also watch for other signs of maternal and baby health and development.

rEvo says if ATryn is approved for preeclampsia, it will be the first drug cleared for the management of the condition between the 24th and 28th week of pregnancy. The trial is expected to begin in May 2014.

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