Kamada Ltd. (Nasdaq and TASE: KMDA) have announced that favorable results from a preclinical study analyzing the effects of the Company's human Alpha-1 Antitrypsin (AAT), Glassia, in inter-species islet graft transplantation were published in PLOS One, an open-access peer-reviewed publication. The article is entitled "Pancreatic Islet Xenograft Survival in Mice Is Extended by a Combination of Alpha-1-Antitrypsin and Single Dose Anti-CD4/CD8 Therapy."

The study was funded by the Juvenile Diabetes Research Foundation and performed by the team of Eli C. Lewis, Ph.D., Director of the Clinical Islet Laboratory, Ben-Gurion University, Negev, Israel.

This study examined transplant survival of pancreatic islets originating in other (xeno) species donors. Pancreatic islet transplantation from other species serves as a model for transplant survival and as a supporting model for type 1 diabetes (T1D) and the beneficial effects of AAT. Similar to the immune rejection of the new pancreatic beta cells, which are recognized as foreign by the host and, therefore, are destroyed by the host immune system, in T1D the immune system attacks and destroys the self pancreatic beta cells (autoimmune attack). The effect of AAT shown in this xenograft transplantation model demonstrates the potential role of AAT in the early stages of T1D.

Recent studies have demonstrated that AAT is an anti-inflammatory and tissue protective protein that also has islet autoimmune-tolerance capabilities. As such, it has the capability to control the immune response to foreign antigens, in this case, to the foreign islets.

Administration of the standard clinically-available treatment to decrease the extent of rejection using monoclonal antibodies alone (anti-CD4/CD8, the equivalent of the clinical regimen anti-thymocyte globulins) didn't achieve long term graft acceptance, yet, in combination with Glassia, there was a significant time extension in graft acceptance and a higher rate of graft acceptance compared with groups that did not receive Glassia. This synergism between these two safe approaches is unprecedented in the field of immune regulation, and could be highly attractive as a strategy for type 1 diabetes.

The investigators assume that temporary elimination of T-cells (achieved by anti-CD4/CD8), together with Glassia, enables a window of improved conditions for xenograft recovery and survival.

Dr. Lewis noted, "AAT is an important protein that is able to control unwanted immune responses and has very strong anti-inflammatory properties which modulate immune processes. This may have great benefit compared with current treatments, such as transplantation, which have issues due to the natural immune attack. In xenograft transplantation, where the rejection is even more potent and challenging, AAT can support the acceptance of a foreign graft and increase transplant prognosis. Improved performance of such unique xenograft transplantations offers the potential for additional safe treatment options for transplant recipients, where today we are limited to using organs from human donors."

"The data are very encouraging and support the continued clinical development of our AAT therapeutic to treat type 1 diabetes," said David Tsur, Chief Executive Officer of Kamada. "We look forward to advancing our AAT therapy in this area of great unmet medical need, and expect to initiate Phase II/III clinical studies in this patient population by year-end."

Mr. Tsur added, "In a previous Phase I/II study in pediatric patients with newly diagnosed type-1 diabetes, our AAT therapeutic had a high safety and tolerability profile and encouraging signs of efficacy including improved metabolic control and beta-cell function 12 to 15 months from diagnosis. This indicated that AAT may have a protective effect on beta cells, leading to a possible halt in disease progression and re-modulation of the autoimmune attack."