PARIS--(BUSINESS WIRE)--LFB SA announced today, through its rEVO Biologics subsidiary, that after the planned interim analysis of the PERSEPT 1 safety and efficacy data by the independent Data Monitoring Committee (DMC), the DMC recommended that the study proceed as planned and also that LFB should expand the global PERSEPT Phase 3 program.
PERSEPT 1 (Program for the Evaluation of Recombinant Factor Seven Efficacy by Prospective Clinical Trials) is a Phase 3 clinical trial of a next generation recombinant form of human Factor VIIa (LR769) in adult and adolescent congenital hemophilia A or B with inhibitors.
The primary role of the DMC—an independent group of medical and scientific experts—is to monitor the scientific and ethical aspects of a study, as well as the safety and efficacy results. Based on their review, they make a recommendation to the sponsor on the trial conduct.
After reviewing the safety and efficacy data collected so far in the pivotal registration study PERSEPT 1, the DMC had no safety concerns. It recommended that the study continues as planned and that the data support the initiation of PERSEPT 2 and 3 which will study the safety and efficacy of LR769 in pediatric patients and around surgeries, respectively. These studies are now expected to start in the second half of this year.
“This is great news for LR769 and our PERSEPT clinical trial program”, said Christian Béchon, Chairman and Chief Executive Officer, LFB SA, “We are committed to a socially responsible approach to the hemophilia community and look forward to bringing product choice and innovation to patients, their caregivers and payers around the world”.
LR769 was developed using rPRO™ technology and is being studied for treatment and prevention of bleeding episodes in hemophilia A and B patients with inhibitors to Factor VIII or IX.
PERSEPT 1 is the first Phase 3 clinical trial in the PERSEPT development program. It is an open-label, multicenter study designed to evaluate the efficacy, safety and pharmacokinetics of LR769 in adolescent and adult patients with hemophilia A and B with inhibitors. The study is evaluating two dosing regimens for the treatment of bleeding episodes.
LFB SA 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 6th 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 50 countries around the world with a global turnover of €477 million in 2013.