Pivotal Phase III Study for Subcutaneous Administration of
Immunoglobulins Fully Enrolled
Baxter International Inc. (NYSE:BAX) and Halozyme Therapeutics, Inc.
(Nasdaq:HALO) today announced completion of patient enrollment in the
Phase III pivotal study of GAMMAGARD LIQUID [Immune Globulin Intravenous
(Human) 10%] (also known as KIOVIG outside of the United States) with
rHuPH20 (recombinant human hyaluronidase enzyme) for the treatment of primary
immunodeficiency disorder (PID). Patients will receive monthly
subcutaneous (SC) injections of Halozyme’s rHuPH20 with Baxter’s GAMMAGARD
LIQUID.
“The achievement of complete Phase III enrollment is an important
milestone of Baxter’s work with Halozyme to offer patients more advanced
treatment options,” said Hartmut J. Ehrlich, M.D., vice president of
Global Research and Development for Baxter’s BioScience business.
“I am pleased with the efficiency and dedication Baxter has demonstrated
toward our collaboration and their exemplary ability to manage and carry
out the clinical objectives,” stated Jonathan Lim, M.D., Halozyme’s
president and CEO. “Completion of patient enrollment in this Phase III
registration study marks a significant and timely accomplishment for the
GAMMAGARD LIQUID-rHuPH20 development program.”
This Phase III clinical trial is a prospective, open-label,
non-controlled design underway in 15 centers in the U.S. and Canada. The
study will evaluate the safety and efficacy of GAMMAGARD LIQUID
administered SC with rHuPH20 in the prevention of acute serious
bacterial infections over 12 months and will also assess pharmacokinetic
parameters of SC GAMMAGARD LIQUID with rHuPH20 compared to intravenous
(IV) administration of GAMMAGARD LIQUID alone. Patient Quality of Life
(QOL) parameters will also be measured. Subcutaneous administration of
GAMMAGARD LIQUID with rHuPH20 in this investigational study will
determine if it will allow PID patients to receive a full monthly dose
in a single injection site in the home setting. GAMMAGARD LIQUID is
currently only approved for IV administration. Additional information
about this Phase III study can be found at clinicaltrials.gov.
About GAMMAGARD LIQUID
GAMMAGARD LIQUID is indicated for the treatment of primary
immunodeficiency disorders associated with defects in humoral immunity.
