Bayer's PROTECT VIII Study Met Its Primary Endpoints
Bayer HealthCare announced positive results from its PROTECT VIII trial assessing the investigational long-acting site-specific PEGylated recombinant human factor VIII compound BAY 94-9027, intended for the treatment of hemophilia A.
The PROTECT VIII study achieved its primary objective of protection from bleeding with fewer infusions. The site-specific PEGylated factor VIII demonstrated increased protection against bleeding when used prophylactically every seven days, every five days, and twice per week. Bayer’s investigational compound also showed efficacy in the treatment of acute and breakthrough bleeding, with 91% of bleed events resolved with only one or two infusions.
Jerry Powell, MD and Director of the Hemophilia Treatment Center at the University of California Davis, said the results were encouraging. “We have found that this investigational site-specific PEGylated factor VIII may help protect patients from bleeds associated with hemophilia A, even when used every seven days. The current standard of treatment requires infusion every two to three days.”
PROTECT VIII (PROphylaxis in hemophilia A patienTs via directly pEgylated long-aCTing rFVIII) is an open-label trial with four treatment arms assessing safety and efficacy of the site-specific PEGylated factor VIII in previously treated adults and adolescents with severe hemophilia A. The multicenter, multinational, and partially randomized study involved 134 patients who were randomized to receive either every five- or seven-day treatment for six months. The study met its safety objectives and confirmed no factor VIII inhibitors were found in patients who were treated up to 36 weeks.
Pamela Cyrus, MD, Vice President and Head, U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals, said, “These data suggest that Bayer's site-specific PEGylated factor VIII may provide longer-lasting protection from bleeds. We are hopeful that less frequent infusions will further support patients in adhering to prophylaxis regimens.”
Hemophilia A is a generally inherited bleeding disorder caused by the deficiency or defective blood coagulation protein. The disease is also known as a factor VIII deficiency or classic hemophilia, as it is the most common type of hemophilia. It is characterized by spontaneous or prolonged bleeding into the muscles, joints, or internal organs.
Source:
http://finance.yahoo.com/news/bayers-long-acting-recombinant-factor-071500114.html