Multicenter Study Results Presented at ISTH
FRAMINGHAM, MA, USA I July 1, 2013 I rEVO Biologics, an LFB company, announced positive preliminary results of a key dose ranging study, which demonstrates that LR769, a novel recombinant form of human Factor VIIa (rhFVIIa), is biologically active and well tolerated in patients with congenital hemophilia A or B at the three dosages tested.
This multicenter study assessed the safety and effects of LR769 at three dose levels – 25, 75 and 225 µg/kg. Each patient received two doses of LR769. The study was sponsored by rEVO and conducted at sites in the United States and Europe. It is being developed for treatment of hemophilia A and B patients with inhibitors to Factor VIII or IX.
Key results from the study, just presented at the XXIV Congress of the International Society on Thrombosis and Haemostasis (ISTH), include:
- LR769 is pharmacodynamically active after a single dose of 25, 75, and 225 µg/kg in hemophilia A or B patients
- Dose-related effects on core coagulation markers (aPTT, PT, and F1+2) were found
- LR769 is well tolerated in hemophilia A or B patients when administered at doses up to 225 µg/kg
- No immune reactions to LR769 were found in any patients after repeated dosing
“The data suggest that LR769 has the potential to provide doctors and patients with a new option in the management of hemophilia A and B,” said Dr. Len Valentino, Professor, Director, Rush Hemophilia and Thrombophilia Center and Section of Pediatric Hematology/Oncology, Rush University Medical Center, “as this data forms a strong basis for further clinical efficacy studies of LR769.”
“We are very encouraged by the success of this study and look forward to sharing this data with global regulatory authorities, including the FDA”. Christian Béchon, Chairman and Chief Executive Officer, LFB S.A, commented today: “We will be working with the regulatory authorities to move on to registrational trials later this year.”
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: 35
Multicenter Study Results Presented at ISTH
FRAMINGHAM, MA, USA I July 1, 2013 I rEVO Biologics, an LFB company, announced positive preliminary results of a key dose ranging study, which demonstrates that LR769, a novel recombinant form of human Factor VIIa (rhFVIIa), is biologically active and well tolerated in patients with congenital hemophilia A or B at the three dosages tested.
This multicenter study assessed the safety and effects of LR769 at three dose levels – 25, 75 and 225 µg/kg. Each patient received two doses of LR769. The study was sponsored by rEVO and conducted at sites in the United States and Europe. It is being developed for treatment of hemophilia A and B patients with inhibitors to Factor VIII or IX.
Key results from the study, just presented at the XXIV Congress of the International Society on Thrombosis and Haemostasis (ISTH), include:
- LR769 is pharmacodynamically active after a single dose of 25, 75, and 225 µg/kg in hemophilia A or B patients
- Dose-related effects on core coagulation markers (aPTT, PT, and F1+2) were found
- LR769 is well tolerated in hemophilia A or B patients when administered at doses up to 225 µg/kg
- No immune reactions to LR769 were found in any patients after repeated dosing
“The data suggest that LR769 has the potential to provide doctors and patients with a new option in the management of hemophilia A and B,” said Dr. Len Valentino, Professor, Director, Rush Hemophilia and Thrombophilia Center and Section of Pediatric Hematology/Oncology, Rush University Medical Center, “as this data forms a strong basis for further clinical efficacy studies of LR769.”
“We are very encouraged by the success of this study and look forward to sharing this data with global regulatory authorities, including the FDA”. Christian Béchon, Chairman and Chief Executive Officer, LFB S.A, commented today: “We will be working with the regulatory authorities to move on to registrational trials later this year.”
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: 35
