Date: 2013-07-01
Type of information: Presentation of results at a congress
phase: 2
Announcement: presentation of preliminary results at the XXIV Congress of the International Society on Thrombosis and Haemostasis (ISTH)
Company: rEVO Biologics (USA - MA), an LFB Company (France)
Product: LR769 (recombinant form of human Factor VIIa - rhFVIIa)
Action
mechanism: protein. 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.
Disease: hemophilia A and B
Therapeutic area: Genetic diseases- Hematological diseases
Country: USA, Europe
Trial
details: This multicenter study was designed to assess the safety, pharmacokinetic and pharmacodynamic properties 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 in Europe.
Latest
news: * On July 1, 2013, rEVO Biologics, an LFB company, has 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.
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
* On June 10, 2013, rEVO Biologics has announced 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. 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.
