Baxter, Halozyme Completes Patient Enrollment For Phase-III Gammagard Liquid Trial

Baxter and Halozyme have completed patient enrollment in the phase III pivotal study of Gammagard Liquid with rHuPH20 (recombinant human hyaluronidase enzyme). It is to be used for the treatment of primary immunodeficiency disorder (PID). Patients would receive monthly subcutaneous (SC) injections of Halozyme’s rHuPH20 with Baxter’s Gammagard Liquid.

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. It will also assess pharmacokinetic parameters of SC Gammagard Liquid with rHuPH20, compared to intravenous (IV) administration of Gammagard Liquid alone. Moreover, the patients Quality of Life (QOL) parameters will also be measured, said the company.

Jonathan Lim, president and CEO of Halozyme, said: 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. Completion of patient enrollment in this Phase III registration study marks a significant and timely accomplishment for the Gammagard Liquid-rHuPH20 development program.