PARIS - Thursday, December 18th 2014 [ME NewsWire]
(BUSINESS WIRE) - LFB S.A. announced today the achievement of patient enrollment target for PERSEPT 1, a multinational Phase 3 clinical trial of LR769, a novel recombinant form of human Factor VIIa, in adolescent and adult congenital hemophilia A or B patients with inhibitors. This Phase 3 trial study is being sponsored by LFB S.A.’s US subsidiary.
“We are very pleased to have reached our patient enrollment target so quickly,” said Christian Béchon, Chairman and Chief Executive Officer, LFB S.A. “This timely enrollment further establishes the support of the healthcare community and patients for an alternative to existing therapies. If ultimately approved by health authorities, LR769 will be the first new therapeutic option in more than 15 years for these very special hemophilia patients and the broader hemophilia community.”
PERSEPT 1 is an open-label, multicenter study designed to evaluate the efficacy, safety and pharmacokinetics of LR769 in 25 adolescent and adult patients with hemophilia A and B with inhibitors. The study will evaluate two different doses and dosing regimens for the treatment of bleeding episodes. All patients enrolled into the trial will be treated and evaluated for at least 6 months. More details can be found at https://clinicaltrials.gov/ct2/show/NCT02020369.
Initial results, expected in the first quarter of 2015, will provide the basis for a second Phase 3 study, PERSEPT 2, which will assess the pharmacokinetics, safety and efficacy of LR769 for the treatment of bleeding episodes in pediatric hemophilia patients with inhibitors. A third study, PERSEPT 3, will evaluate the safety and efficacy of LR769 for prevention of bleeding in patients undergoing surgery. Both studies are expected to begin in mid 2015.
LFB S.A. (www.lfb.fr) is a multinational biopharmaceutical company 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.
LFB S.A. is the leading manufacturer of plasma-derived medicinal products in France and 6th worldwide, and is also among the leading European companies for the development of new-generation medicinal products or treatments based on biotechnologies.
LFB S.A. is pursuing a growth strategy that seeks to extend its international activities and develop innovative therapies. Today, LFB S.A. currently markets its products in more than 40 countries around the world with a global turnover of €477 million in 2013.
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