FRAMINGHAM, MA, USA I June 10, 2013 I rEVO Biologics, an LFB Company,announced today that it has completed the treatment and follow up phase of a key dose ranging study of LR769, a novel recombinant form of human Factor VIIa (rhFVIIa), in patients with congenital hemophilia A or B. Results from the study will be presented at the XXIV Congress of the International Society on Thrombosis and Haemostasis (ISTH), which takes place June 29–July 4, 2013, in Amsterdam, The Netherlands.
LR769 is a novel compound, developed in cooperation with LFB Biotechnologies and produced through proprietary rPRO transgenic technology. It is being developed for treatment of hemophilia A and B patients with inhibitors to Factor VIII or IX. This multicenter study was designed to assess the safety, pharmacokinetic and pharmacodynamic properties of LR769 at three dose levels. Each patient received two doses of LR769. The study was sponsored by rEVO and conducted at sites in the United States and in Europe.
The pharmacokinetic and pharmacodynamic data will provide the basis for further clinical efficacy studies of LR769. rEVO will be working with global regulatory authorities, including FDA, to initiate a Phase 3 registrational study later this year.
“rEVO is committed to developing innovative, cost-effective therapies to treat rare conditions,” said Mr. Christian Béchon, Chairman and Chief Executive Officer, LFB S.A.. According to Jerry Powell M.D., Professor, Director, Hemophilia and Thrombosis Center, UC Davis, one of the study investigators, “It’s been almost 15 years since a new recombinant Factor VIIa treatment has been approved in the United States for treatment of hemophilia A and B patients with inhibitors to Factor VIII or IX. If proven safe and effective, LR769 would provide healthcare professionals with an important therapeutic treatment for hemophilia patients.”
About rEVO Biologics
rEVO Biologics (www.revobiologics.com) is a rare disease company focused on developing and delivering first- and next-generation therapeutics that are more cost effective to produce than traditional recombinant therapies. Through its proprietary rPRO Technology platform—a scalable, transgenic, and cost-effective method of protein production—rEVO Biologics is bringing safe and reliable therapeutic proteins to address critical medical needs. The company’s lead product, ATryn, is the first and only plasma-free antithrombin concentrate. ATryn received FDA approval in 2009. The company has a number of products in its pipeline and in clinical trials in the areas of hematology, oncology, genetic disorders, and autoimmune disease, and is actively seeking additional indications for its lead product.
About LFB group
LFB 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 20 countries around the world with a global turnover of €466 millions in 2012.
SOURCE: rEVO Biologics
Post Views: 30
FRAMINGHAM, MA, USA I June 10, 2013 I rEVO Biologics, an LFB Company,announced today that it has completed the treatment and follow up phase of a key dose ranging study of LR769, a novel recombinant form of human Factor VIIa (rhFVIIa), in patients with congenital hemophilia A or B. Results from the study will be presented at the XXIV Congress of the International Society on Thrombosis and Haemostasis (ISTH), which takes place June 29–July 4, 2013, in Amsterdam, The Netherlands.
LR769 is a novel compound, developed in cooperation with LFB Biotechnologies and produced through proprietary rPRO transgenic technology. It is being developed for treatment of hemophilia A and B patients with inhibitors to Factor VIII or IX. This multicenter study was designed to assess the safety, pharmacokinetic and pharmacodynamic properties of LR769 at three dose levels. Each patient received two doses of LR769. The study was sponsored by rEVO and conducted at sites in the United States and in Europe.
The pharmacokinetic and pharmacodynamic data will provide the basis for further clinical efficacy studies of LR769. rEVO will be working with global regulatory authorities, including FDA, to initiate a Phase 3 registrational study later this year.
“rEVO is committed to developing innovative, cost-effective therapies to treat rare conditions,” said Mr. Christian Béchon, Chairman and Chief Executive Officer, LFB S.A.. According to Jerry Powell M.D., Professor, Director, Hemophilia and Thrombosis Center, UC Davis, one of the study investigators, “It’s been almost 15 years since a new recombinant Factor VIIa treatment has been approved in the United States for treatment of hemophilia A and B patients with inhibitors to Factor VIII or IX. If proven safe and effective, LR769 would provide healthcare professionals with an important therapeutic treatment for hemophilia patients.”
About rEVO Biologics
rEVO Biologics (www.revobiologics.com) is a rare disease company focused on developing and delivering first- and next-generation therapeutics that are more cost effective to produce than traditional recombinant therapies. Through its proprietary rPRO Technology platform—a scalable, transgenic, and cost-effective method of protein production—rEVO Biologics is bringing safe and reliable therapeutic proteins to address critical medical needs. The company’s lead product, ATryn, is the first and only plasma-free antithrombin concentrate. ATryn received FDA approval in 2009. The company has a number of products in its pipeline and in clinical trials in the areas of hematology, oncology, genetic disorders, and autoimmune disease, and is actively seeking additional indications for its lead product.
About LFB group
LFB 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 20 countries around the world with a global turnover of €466 millions in 2012.
SOURCE: rEVO Biologics
Post Views: 30
