Kamada Reports Interim Data From Human Alpha-1 Antitrypsin Clinical Study

(RTTNews) - Kamada Ltd. (KMDA) reported that preliminary results from a Phase I/II clinical study of the human Alpha-1 Antitrypsin, or AAT, indicated that continuous administration of AAT as therapy for steroid resistant gut graft-versus-host-disease, or GvHD, is feasible in the subject population. Indication of healing of the bowel mucosa was seen to decrease in diarrhea, in intestinal protein loss, including AAT, and in endoscopic evaluation. Following examination of pro-inflammatory cytokines, in the preliminary results AAT administration suppressed serum levels of pro-inflammatory cytokines and interfered with GvHD biomarkers.

The Phase I/II study is being conducted by the Fred Hutchinson Cancer Research Center in Seattle, Washington in cooperation with Baxter International Inc. and Kamada using Kamada's AAT. The study is an open label, dose escalation, safety and efficacy study. The study is evaluating 24 GvHD patients who suffer from inadequate response to steroid treatment following HCT. The primary outcome of the study is to evaluate the efficacy of AAT in ameliorating the severe intestinal inflammation associated with GvHD.

David Tsur, co-Founder and CEO of Kamada, said: "These positive interim results are very promising and encouraging, supporting our decision to continue to pursue our global clinical development plans for AAT in treating and preventing GvHD. Importantly, the preclinical data support the positive interim results from the Phase I/II clinical study of AAT, which is aimed at treating the gut involvement in steroid-resistant GvHD."