GTC Biotherapeutics (GTCB) And Partner File IND for rhFVIIa
GTC Biotherapeutics, Inc. (NASDAQ: GTCB) and its strategic partner LFB Biotechnologies (Les Ulis, France) announced that, following discussions with the FDA, they are moving forward with their plans to file an IND for a phase I study for the transgenically derived recombinant human Factor VIIa (rhFVIIa) being developed in their joint venture. This rhFVIIa is being developed for the treatment of hemophilia patients who have developed antibodies to Factor VIII or Factor IX. GTC and LFB plan to initiate the phase I study in the second quarter of 2010.
"The rhFVIIa program we are developing with our partner LFB is a very high priority for us", said Geoffrey Cox, Ph.D., Chairman, President and CEO of GTC Biotherapeutics. "We look forward to the filing of the IND and the initiation of the phase I study as the next steps in the development of a cost effective alternative for the treatment of hemophiliacs".
FVIIa is used to treat patients that have developed antibodies to Factor VIII or Factor IX. As planned, the phase I study will be performed in normal healthy volunteers to assess product safety and to compare the pharmacokinetic and pharmacodynamic properties of our product rhFVIIa against NovoSeven(R). NovoSeven(R) is a recombinant Factor VIIa product of Novo Nordisk which was reported in 2008 to have worldwide sales of $1.2 billion. Results from this initial study are expected by the end of the fourth quarter of 2010. Following the successful completion of this clinical trial, GTC and LFB intend to pursue development of rhFVIIa in the target patient population of hemophilia A and hemophilia B patients that have developed inhibitors.
"The rhFVIIa program we are developing with our partner LFB is a very high priority for us", said Geoffrey Cox, Ph.D., Chairman, President and CEO of GTC Biotherapeutics. "We look forward to the filing of the IND and the initiation of the phase I study as the next steps in the development of a cost effective alternative for the treatment of hemophiliacs".
FVIIa is used to treat patients that have developed antibodies to Factor VIII or Factor IX. As planned, the phase I study will be performed in normal healthy volunteers to assess product safety and to compare the pharmacokinetic and pharmacodynamic properties of our product rhFVIIa against NovoSeven(R). NovoSeven(R) is a recombinant Factor VIIa product of Novo Nordisk which was reported in 2008 to have worldwide sales of $1.2 billion. Results from this initial study are expected by the end of the fourth quarter of 2010. Following the successful completion of this clinical trial, GTC and LFB intend to pursue development of rhFVIIa in the target patient population of hemophilia A and hemophilia B patients that have developed inhibitors.
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