NEW YORK--(BUSINESS WIRE)--10,000 babies in the United States and European Union suffer each year from a potentially crippling and fatal bleeding disorder called Fetal and Neonatal Alloimmune Thrombocytopenia, or FNAIT. Currently no therapy exists to prevent FNAIT. FNAIT occurs when a mother develops antibodies against her baby’s platelets, an important blood component that stops bleeding. Today, however, New York City’s top medical powerhouses and BloodCenter of Wisconsin announced they are joining with Prophylix Pharma and the EU-funded PROFNAIT consortium of ten universities, hospitals and research organizations to develop a product called NAITgam for prevention of FNAIT.
As a first step, Prophylix Pharma and BloodCenter of Wisconsin will help identify blood plasma donors among women who have had babies affected by FNAIT. New York Blood Center will then collect the donor’s plasma, and has applied to the Food and Drug Administration for a Source Plasma License, a necessary component to its collaboration. The collected plasma will be made into NAITgam which will be given to at-risk pregnant women so they do not make antibodies against their baby’s platelets. This may prevent FNAIT in current and future pregnancies.
NAITgam is very similar to Rh immune globulin which for almost 50 years has proven safe and effective in almost eliminating a related condition, Hemolytic Disease of the Fetus and Newborn – caused by mothers making antibodies against their babies’ red blood cells.
Dr. Søren Weis Dahl, Chief Business Officer and EU Project Coordinator, Prophylix Pharma AS comments, “Access to the specialty source plasma that New York Blood Center is now starting to collect for the PROFNAIT project is essential for our ability to manufacture and develop NAITgam.”
Dr. Beth H. Shaz, Chief Medical Officer, New York Blood Center adds, “Saving lives is what the New York Blood Center is all about. We’re excited to participate in a program that could alleviate so much of the suffering endured by families potentially affected by this bleeding disorder.”
About New York Blood Center
Now celebrating its 50th anniversary, New York Blood Center (NYBC) is one of the largest independent, community-based blood centers in the country. Each year, NYBC provides approximately one million blood products to nearly 200 hospitals in the Northeast. NYBC also provides a wide array of transfusion-related medical services. NYBC is also home to the world’s largest public cord blood bank, which provides stem cells for transplant in many countries, and a renowned research institute, which – among other milestones -- developed the Hepatitis B vaccine and innovative blood purification technology. Website: www.nybloodcenter.org
About Prophylix Pharma
Prophylix Pharma AS coordinate the PROFNAIT consortium’s drug development activities and lead the procurement of specialty source plasma in the US and manufacture of NAITgam. In addition, Prophylix develops a test for routine typing of pregnant women to identify those at risk of causing FNAIT in their baby. Further information about Prophylix Pharma can be found at www.prophylixpharma.com and at www.profnait.eu.
About BloodCenter of Wisconsin
BloodCenter of Wisconsin is a not-for-profit organization that specializes in blood services, organ, tissue and marrow donation, diagnostic testing, medical services and leading-edge research. BloodCenter of Wisconsin advances patient care by delivering life-saving solutions grounded in unparalleled medical and scientific expertise. BCW’s Platelet and Neutrophil Immunology Laboratory has pioneered diagnostic testing in the area of FNAIT for over three decades. For more information, visit www.bcw.edu.