Kamada Ltd. reported further positive interim results from a phase 1/2 clinical trial of its proprietary alpha-1 antitrypsin (AAT) to treat steroid-refractory Graft Versus Host Disease (GvHD) which is being conducted in collaboration with Baxalta US Inc. and the Fred Hutchinson Cancer Research Center in Seattle. These interim results are from a Phase 1/2 open-label, single-site study of patients with steroid-refractory GvHD following allogeneic hematopoietic stem cell transplantation (HSCT), who received Kamada's intravenous (IV) AAT, and reported on outcomes from the 12 subjects enrolled in Cohorts 1 and 2 who were treated at two dose levels of AAT. All subjects had GvHD of Grade III or IV with stage 4 intestinal involvement.

The interim results showed that plasma AAT levels increased in both cohorts and remained stable for the duration of treatment. Treatment responses were evaluated as “peak” response and at Day 28. Eight of the twelve subjects showed an overall response to treatment, four of which were complete responses and four were partial responses.

Interim results from the first cohort of this study were presented as a poster at the American Society of Hematology (ASH) Annual Meeting in December 2014. Preliminary results indicate that continuous administration of AAT as therapy for steroid-refractory gut GvHD is feasible in the subject population. Subjects who responded to Kamada's IV AAT had a decrease or cessation of diarrhea, a decrease in intestinal AAT loss and an improvement in endoscopic evaluation.