Tissera, Inc. (OTCBB: TSSR – News) reports the achievement of a significant milestone in its ongoing large animal diabetic model experiments of pancreatic xenotransplantation, designed for the future treatment of insulin-dependent (type I) diabetes mellitus.

Based on the previously reported  positive results obtained in pancreatic transplantation experiments in normal non human primates, Tissera's sponsored research team at the Weizmann Institute of Science has moved forward to investigate in diabetic non human primates the functional and therapeutic value of the company's approach. In these studies, non human primates are treated by an agent called streptozotocin which induces them to become diabetic and consequently dependent upon administration of exogenous insulin for the maintenance of reasonable blood sugar levels. After allowing a few weeks for stabilization, appropriately timed pig embryonic pancreatic tissue is transplanted into the diabetic primate, which is thereafter intensively and carefully followed.   

A progressive post transplantation reduction of the insulin amounts required for maintenance of near normal blood sugar levels was observed, with less than 10% of starting daily insulin dose by the fourth month after transplantation and reaching complete exogenous insulin independence at around 5 months after transplantation, meaning that endogenous insulin production had taken over control of blood sugar levels. C-peptide blood levels were predominantly of pig origin, this being very significant in pointing to the pig origin of insulin presence, as C-peptide production has a strong correlation with insulin production.

Another major issue addressed in the company's primate studies is that of the dosage of immune suppression treatment needed for the prevention of graft rejection. In the company's most recent study on a diabetic primate, significantly reduced immune suppression dosing to levels acceptable for humans was practiced, bearing considerably less side effects on the primate recipient. Nonetheless, insulin independence was achieved  at 18 weeks after transplantation and the primate has benefited from an uneventful course all along the way. Currently, at 31 weeks after transplantation, the primate is well and alive and continues to be free from exogenous insulin administration. This is a significant step forward in the company's ongoing plan to further reduce and optimize its immune suppression protocol, which constitutes an important parameter of the human applicability of the company's technology.

Those results provide a solid proof of principle for the therapeutic potential of the company's approach to the treatment of insulin dependent (type I) diabetes. Further studies are under way, both to establish the reproducibility of those experiments and to explore the full potential of transplantation of appropriately timed pig embryonic pancreatic tissue in achieving sustained curative function in diabetic subjects under further reduction of immune suppression.  

Amos Eiran, Tissera's Chairman & CEO comments: "We are very much encouraged by the great progress we have made in our diabetic primate model experiments, both in achieving a proof of concept for the therapeutic efficacy of our approach and in reducing the immune suppression dosage needed to prevent graft rejection. We are engaged in additional experiments in the diabetic primate model, aiming at  further advancing the company towards its next goal of applying in the very near future for the initiation of human clinical studies on type I diabetic patients".

About Diabetes Mellitus

Diabetes mellitus is a severe and debilitating chronic disease that develops in nearly 5 percent of the world’s population.  People with this disease have a shortage of insulin or a reduced ability to use insulin, the hormone regulating blood glucose levels, which is normally produced by the pancreas. In the United States alone, an estimated 18 million people have diabetes, and each year about 1 million Americans are diagnosed with the disease.  It is the sixth leading cause of death in the US and is responsible for over 200,000 deaths a year. Insulin-dependent (type I) diabetes accounts for around 10% of diabetics. For those patients, suffering from an inability of their pancreas to produce insulin, the only practical treatment possible is regular insulin replacement by multiple daily injections. Transplantation of a pancreas or pancreatic tissue would be beneficial to millions of such patients in that it would restore their normal ability to produce self insulin. Transplantation of human pancreas or pancreatic islets is a practiced and time-honored  such therapeutic approach, but is extremely limited by the severe shortage of human donor organs. Tissera's R&D efforts in this domain are directed towards the development of a universally available and reliable source of animal fetal donor pancreatic precursor tissue, suitable for transplantation and eventual normal structural and functional growth in human diabetics.

About Tissera

Tissera is a biotechnology company dedicated to the development of novel tissue precursor regeneration technologies for treating gene deficiencies and diseases in which organ transplantation is necessary, while minimizing the dosage of immunosuppressive drugs. Tissera obtained the license for the worldwide exclusive rights to the technology developed by Professor Yair Reisner and his team at the Weizmann Institute of Science in Israel. In this research, scientists successfully implanted in mice embryonic human and porcine organ precursor tissues, which grew into functional organs. This research was published in Nature Medicine and attracted worldwide scientific and media attention.

For more information please visit Tissera website:

CONTACT:    

Tissera Inc.

Dr. Uri Elmaleh 

uri@tissera.com

+972-52-5716669

SOURCE: Tissera, Inc.