ME Newswire / Businesswire
FRAMINGHAM, Mass. - Thursday, May 15th 2014
LFB SA, through its U.S. subsidiary, announced today that the first patient has begun treatment with LR769 in a Phase 3 clinical trial of this novel recombinant form of human Factor VIIa in patients with congenital hemophilia A or B with inhibitors.
This Phase 3 clinical trial is a global open-label, multicenter study designed to evaluate the efficacy, safety and pharmacokinetics of LR769 in adolescent and adult hemophilia A and B patients with inhibitors. The study will evaluate two dosing regimens for the treatment of bleeding episodes and should be completed in 2015. More details can be found on www.clinicaltrials.gov, study identifier NCT02020369.
“The start of patient treatment is an important milestone in the development of LR769 for hemophilia A and B patients with inhibitors to Factor VIII or IX. LFB is committed to working with the hemophilia community to find new treatment options for this condition and to improve the lives of people with hemophilia," commented Christian Béchon, Chairman and Chief Executive Officer, LFB SA. "Based on promising data from earlier studies, we believe that LR769 has the potential to be a significant advance for people with hemophilia, and we will fully explore its potential as the first new therapeutic option in more than 15 years."
Additional Phase 3 studies will assess the efficacy of LR769 for the treatment of bleeding episodes in pediatric hemophilia patients with inhibitors and will evaluate the prevention of bleeding complications in patients undergoing surgery. These studies are expected to start in early 2015.
About LFB group
LFB (www.lfb.fr) is a biopharmaceutical group that develops, manufactures and markets medicinal products for the treatment of serious and often rare diseases in major therapeutic fields, namely hemostasis, immunology and intensive care. The LFB Group is the leading supplier 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 derived from biotechnologies. The LFB Group is pursuing a growth strategy that seeks to extend its activities at the international level and develop innovative therapies. The LFB Group currently markets its products in 30 countries around the world with a global turnover of €477 million in 2013.
Sandrine Charrieres / Anne Caubit, +33 1 6982 7280