Use of recombinant factor VIIa
to facilitate organ donation in trauma patients with devastating neurologic injury.
Recombinant factor VIIa
is indicated for the treatment of hemorrhages in patients with hemophilia A or B with inhibitors of factor VIII or factor IX.
Because synthetic factor VIIa
requires tissue factor for activation, and because tissue factor is released only with vascular damage, the risk of excessive thrombogenesis should be limited.
Administration of high dose rFVIIa results in supra-normal levels of factor VIIa
causing faster and greater thrombin generation (11).
Treatment of excessive bleeding in Jehovah's Witness patients after cardiac surgery with recombinant factor VIIa
Currently available commercial factor VIIa
must be administered through IV infusion, which can be onerous for patients.
Successful treatment of refractory bleeding with recombinant factor VIIa
after redo coronary artery bypass graft surgery.
Looking ahead, GTC will concentrate its efforts on achieving three key goals: to progress the Factor VIIa
program into first-in-man studies, currently expected to begin late this year; to improve the financial performance of ATryn[R], the first product developed, approved (in the US and EU) and manufactured using GTC's transgenic technology; to leverage the power of our transgenic platform to advance additional protein therapeutic candidates, especially in the area of 'bio-similar' product candidates.
Alternative drugs for bridging inhibitory activity, coagulation factor viia
eptacog alfa ( activated) 1 mg, coagulation factor viia
eptacog alfa ( activated) 2 mg and factor viii inhibitor bypassing activity 500 ie.
Studies will feature research on novel investigational recombinant factor VIIa
, VIII and IX therapies for hemophilia A and B
GTC, together with its collaboration partner LFB Biotechnologies, has established the transgenic rabbit production system for its human coagulation factor VIIa
(rhFVIIa) program and is well advanced in the preparations to initiate a Phase I study in the 2nd quarter of 2010.
Table 28 Clinical Stage Recombinant Factor VIIa
The TRUST (TReatment with Unique recombinant rFVIIa STudy) trial is a Phase II/III, multicenter, open-label clinical study designed to assess the safety and efficacy of BAY 86-6150, a recombinant factor VIIa
(rFVIIa) protein, in patients with hemophilia A or B with inhibitors.
NAARDEN, Netherlands -- BAC BV, the leading provider of antibody-based affinity purification technology, has announced that it has extended its license agreement with LFB Biotechnologies (Les Ulis, France), to cover the use of BAC's anti-Factor VIIa
CaptureSelect([R]) affinity ligand in the large-scale purification of recombinant human Factor VIIa
As per this deal, Novo Nordisk will buy the exclusive worldwide rights for Pharmacyclics small molecule Factor VIIa
inhibitor, PCI-27483, in a restricted disease indication outside of oncology.