Baxter International Inc and Halozyme Therapeutics, Inc announced the start of a phase-III clinical trial of Baxter's Gammagard Liquid [Immune Globulin Intravenous] 10 per cent (IGIV), marketed as Kiovig in the European Union, with Halozyme's recombinant human hyaluronidase enzyme (rHuPH20, Enhanze Technology) for the treatment of primary immunodeficiency (PID). The purpose of this clinical trial is to evaluate the safety and efficacy and gain regulatory approval for the treatment of PID using Gammagard Liquid and rHuPH20 via subcutaneous (under the skin) injection at a single site.
Gammagard Liquid is currently administered intravenously (IV). Subcutaneous (SC) administration of Gammagard Liquid with Enhanze Technology is an investigational study and when approved could allow patients to receive a full monthly dose in a single injection site in their home setting.
"Baxter's work with Halozyme represents a commitment to innovation and, in particular, to advancing patient care with Gammagard Liquid," said Hartmut J Ehrlich, vice president of Global Research and Development for Baxter's BioScience business.
"Entering phase-III clinical development is an important achievement for our hyaluronidase enzyme and for our collaboration with Baxter. We are pleased with the progress that has been made since our alliance began in September 2007," stated Jonathan Lim, president and CEO of Halozyme. "We look forward to continuing our strong working relationship with the Baxter team and to further advance this programme."
This phase-III clinical study is a prospective, open-label, non-controlled design that will be conducted in 10-20 centers in the US and Canada. The trial will evaluate the efficacy of Gammagard Liquid administered SC with rHuPH20 in the prevention of acute serious bacterial infections and will also assess pharmacokinetic parameters of SC and rHuPH20 compared to intravenous administration.
Gammagard Liquid is indicated for the treatment of primary immunodeficiency disorders associated with defects in humoral immunity.
Important Safety Information
Baxter International Inc. develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions.
Halozyme is a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the endocrinology, oncology, dermatology, and drug delivery markets.