rEVO Biologics, UAB Begin Phase III Trial For ATryn In Preeclampsia
By Cyndi Root
The University of Alabama at Birmingham (UAB) announced in a press release that it has begun a preeclampsia trial using ATryn, produced by rEVO Biologics. The Department of Obstetrics and Gynecology at UAB enrolled its first patient in the Phase III trial of the drug that shows promise in reducing pre-term births and infant mortality. The UAB Maternal-Fetal Medicine Specialists expect to enroll 120 women from the U.S. in the next 18 months. Lead investigator Alan Tita, M.D., Ph.D., said, “Currently, when patients have preeclampsia, all we have to offer is delivery of the baby as the ultimate treatment. For the target group, women in their 24th to 28th week of pregnancy, this could be a substantial advance in the treatment of preeclampsia and significantly improve outcomes for mother and baby.”
ATryn Phase III Trial
UAB’s Women and Infants Center is part of the National Institutes of Health (NIH) Maternal-Fetal Medicine Units Network. The study of ATryn in the PRESERVE-1 trial is a placebo-controlled Phase III trial. Pregnant women will receive the agent in the 24th to 28th week of pregnancy. Investigators hope to prolong pregnancy and reduce high rates of perinatal mortality due to the high blood pressure and damage to organs caused by preeclampsia. The trial will evaluate safety and efficacy and help develop a pharmacokinetic profile.
ATryn
rEVO Biologics’ agent, ATryn, an antithrombin recombinant, is for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients and not for treatment of thromboembolic events. ATryn is a plasma-free antithrombin concentrate, developed using rPRO Technology, a method of recombinant protein production. The Food and Drug Administration (FDA) approved ATryn is 2009 for the prevention of blood clots in patients with hereditary antithrombin (AT) deficiency.
About rEVO Biologics
rEVO Biologics, which is from Framingham, MA with production facilities in Charlton, MA, focuses on rare diseases using recombinant medicine. The company announced in January 2013 that it was changing its name from GTC Biotherapeutics to rEVO Biologics. Originally a spinoff of Genzyme Corporation, GTC stood for Genzyme Transgenics Corporation. The company states that the name change reflects its core business strategy of recombinant medicine for rare diseases.