FRAMINGHAM, MA, USA I July 23, 2014 I EVO Biologics, Inc., a subsidiary of LFB Biotechnologies, today announced the enrollment of the first patient in its Phase 3 clinical trial of ATryn® [antithrombin (Recombinant)], for the treatment of preeclampsia during the 24th to 28th week of pregnancy, or early onset preeclampsia. The objective of the PRESERVE-1 trial is to assess whether ATryn prolongs pregnancy in mothers with early onset preeclampsia, consequently reducing the high rates of neonatal mortality and disability caused by this condition.
The first patient was enrolled by Alan Tita, M.D., Ph.D., Professor of Obstetrics and Gynecology and his team at the University of Alabama, Birmingham. “As a physician faced with the difficult challenge of managing preeclampsia early in pregnancy, I see first-hand the significant need for new medicines to safely extend pregnancy and give a baby more time to develop in utero,” said Dr. Tita. “Our team is thrilled with the opportunity to participate in PRESERVE-1 – an important Phase 3 trial designed to assess the potential benefits of ATryn in a clear area of unmet medical need.”
“With our trial of ATryn in early onset preeclampsia now underway, we look forward to having clinical investigators across the country join us in assessing ATryn as a treatment option for a subset of women with early onset preeclampsia who are faced with delivering a severely premature baby,” said Yann Echelard, Ph.D., President and CEO, rEVO Biologics.
The primary objective of the PRESERVE-1 randomized double-blind, placebo-controlled trial is to assess the efficacy, safety and pharmacokinetics of ATryn for the treatment of early onset preeclampsia when used together with expectant management, the current standard of care. Efficacy will be assessed by comparing the difference in gestational age from the time of randomization into the trial until delivery of the baby in women given ATryn to those given placebo. The effect of ATryn on neonatal clinical outcomes will also be assessed. This trial is currently enrolling patients in the United States.
Preeclampsia is a life-threatening progressive condition that occurs in approximately five to eight percent of all pregnancies and typically occurs after the twentieth week of pregnancy. The cause of preeclampsia is unknown, but the number of cases is growing. According to the American Congress of Obstetricians and Gynecologists (ACOG), in the United States, the incidence of the disorder has increased by approximately 25 percent from 1987 to 2004. At present, delivery of the baby is the only known way to stop the progression of preeclampsia, which without intervention can escalate to multiorgan failure, seizures, coma or death for the mother and baby.
About the PRESERVE-1 Clinical Trial
PRESERVE-1 (Pharmacokinetics, Safety and Efficacy Study of Recombinant Antithrombin Versus Placebo in Preterm Preeclampsia) is a Phase 3, randomized, double-blind, placebo-controlled trial of 120 patients assessing the safety, efficacy and pharmacokinetics of ATryn, in patients who are being expectantly managed for early onset preeclampsia.
Efficacy will be assessed by comparing the difference in gestational age from the time of randomization into the trial until delivery of the baby for women given ATryn to those given placebo. The effect of ATryn on neonatal clinical outcomes will also be assessed.
About Preeclampsia
Preeclampsia is a condition that only occurs in pregnancy and affects the placenta. Abnormal development of blood vessels from the uterus to the placenta may lead to decreased blood flow, nutrients and oxygen from mother to baby, placing the baby at risk for prematurity and abnormal fetal growth. The lining of the blood vessels (endothelium) also becomes damaged causing inflammation that extends from the placenta throughout the mother’s blood vessels and internal organs. As a result, high blood pressure, stroke, seizures and liver and kidney problems can occur or even death for mother or baby.
Preeclampsia and related conditions like HELLP syndrome (hemolysis, elevated liver enzymes and low platelet count) and eclampsia are characterized by a rapid rise in blood pressure for the mother that may lead to seizure, stroke, multiple organ failure or even death for mother or baby. The Preeclampsia Foundation estimates the annual cost of preeclampsia is more than $7.0 billion in the United States, including approximately $3.0 billion relating to maternal disabilities and approximately $4.0 billion relating to infant morbidity.
About ATryn
Indications and Usage
ATryn is a recombinant antithrombin indicated for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients.
It is not indicated for treatment of thromboembolic events in hereditary antithrombin deficient patients.
Important Safety Information
ATryn is contraindicated in patients with known hypersensitivity to goat and goat milk proteins. Allergic-type hypersensitivity reactions, including anaphylaxis, are possible. Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. If these symptoms occur during administration, treatment must be discontinued immediately and emergency treatment should be administered.
The anticoagulant effect of drugs that use antithrombin to exert their anticoagulation may be altered when ATryn is added or withdrawn. To avoid excessive or insufficient anticoagulation, coagulation tests suitable for the anticoagulant used (e.g., aPTT and anti-Factor Xa activity) are to be performed regularly at close intervals and in particular in the first hours following the start or withdrawal of ATryn. Additionally, patients should be monitored for the occurrence of bleeding or thrombosis in such situations.
The serious adverse reaction that has been reported in clinical studies is hemorrhage (intra-abdominal, hemarthrosis and post procedural). The most common adverse events reported in clinical trials at a frequency of ≥5% are hemorrhage and infusion site reaction.
For more information, please view full Prescribing Information for ATryn, visit www.atryn.com or call 1-800-610-3776.
To report suspected adverse reactions contact rEVO Biologics, Inc. at 1-800-610-3776 or the FDA at 1-800-FDA-1088 or www.fda.gov/MedWatch.
About rEVO Biologics
rEVO Biologics, Inc. (www.revobiologics.com) is a commercial-stage biopharmaceutical company focused on the development and commercialization of specialty therapeutics to address unmet medical needs in patients with rare, life-threatening conditions. The company’s lead product, ATryn, is the first and only plasma-free antithrombin concentrate. ATryn received FDA approval in 2009 for the prevention of peri-operative and peri-partum thromboembolic events in hereditary antithrombin deficient patients. The company has a number of products in its pipeline and is actively seeking additional indications for its lead product.
About LFB Group
The LFB Group is a biopharmaceutical group that develops, manufactures and markets medicinal products for the treatment of serious and often rare diseases in several major therapeutic fields, including hemostasis, immunology and intensive care. The LFB Group is the leading manufacturer of plasma-derived medicinal products in France and sixth worldwide and is also among the leading European companies for the development of new-generation medicinal products or treatments based on biotechnologies. The LFB Group is pursuing a growth strategy that seeks to extend its activities at the international level and develop innovative therapies. To that end, the LFB Group currently markets its products in 30 countries around the world with a global turnover of €477 million in 2013.
SOURCE: LFB Group
