Maxygen receives approval for trial of factor VIIa in UK

Jun 11 2008

Maxygen, Inc. today announced that it has filed a Clinical Trial Authorization (CTA) and received the necessary approvals in the United Kingdom to initiate a first-in-human Phase I trial of MAXY-VII in hemophilia patients.

MAXY-VII is the company's next-generation Factor VIIa protein for the treatment of hemophilia. Patient dosing is on schedule to begin in the second half of this year.

"I'd like to congratulate our clinical team for meeting its goal of filing a CTA in the first half of 2008, and for obtaining a rapid approval," said Russell Howard, chief executive officer of Maxygen. "In addition to expedient management of MAXY-VII, the team has kept the MAXY-G34 G-CSF Phase IIa program moving forward on schedule. We expect to be able to share preliminary results from that program by the end of this year."

MAXY-VII is designed to be an improved Factor VIIa for the treatment of hemophilia patients. Hemophilia is a serious medical condition that causes frequent bleeding episodes due to the absence of a particular blood clotting factor. The majority of hemophilia patients are known to have an absence of Factor VIII (known as Hemophilia A), while others are known to be deficient in Factor IX (Hemophilia B).

The primary treatment for hemophilia is replacement of FVIII and FIX clotting factor in Hemophilia A and B patients, respectively. Over time, some patients develop antibodies to these replacement factors (frequently referred to as inhibitors). Recombinant Factor VIIa is approved for the treatment of hemophilia patients with inhibitors. Treatment with recombinant Factor VII can be expensive and cumbersome, with patients often receiving multiple doses until bleeding has been completely stopped. MAXY-VII, which has been shown in preclinical animal studies and in in vitro human blood studies to be a more potent form of Factor VIIa, may provide improved efficacy and dosing convenience.

http://www.maxygen.com