NESS ZIONA, Israel, Nov. 02, 2016 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ:KMDA) (TASE:KMDA), a plasma-derived protein therapeutics company focused on orphan indications, today announced the clinical plan for the initiation of a Phase 2/3 clinical trial in the United States of its Alpha-1 Antitrypsin (G1-AAT IV) for the treatment of acute Graft-Versus-Host Disease (GvHD), in collaboration with Shire plc. Kamada and Shire (Baxter at the time) entered into an exclusive strategic cooperation agreement for the distribution and license of Kamada's AAT IV in 2010. Under the terms of the agreement, Shire is the exclusive distributor of the product in the U.S., Canada, Australia and New Zealand. GvHD can occur after a stem cell or bone marrow transplant where newly transplanted donor cells attack the recipient. G1-AAT IV previously received orphan drug designation from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for the treatment of GvHD, and an Investigational New Drug Application was submitted to the FDA earlier this year. "The imminent initiation of this study for acute GvHD represents a significant accomplishment for Kamada and our clinical development plan for AAT IV to treat GvHD, and importantly, signifies another key milestone resulting from our partnership with Shire," said Amir London, Kamada's Chief Executive Officer. "We believe G1-AAT IV has the potential to address a significant unmet need in the treatment of GvHD, which is a life-threatening disease." This Phase 2/3 clinical trial will be a two-part, multi-center, prospective study to evaluate the safety and efficacy of G1-AAT IV as an add-on biopharmacotherapy to conventional steroid treatment in up to 168 patients with acute GvHD with lower gastrointestinal involvement (LGI-aGvHD). The first part of the trial will be single-arm, open-label and will include 20 patients, while the second will be placebo-controlled, double-blind with approximately 148 patients in two arms. The primary endpoint of the study will be overall response (complete response (CR) and partial response (PR)) rate at Day 28. GvHD CR is complete resolution of all signs and symptoms of acute GvHD in all organs without intervening salvage. GvHD PR is improvement of one stage in one or more organs involved in GvHD without progression in other organs. Study results are expected to be available in 2020.