During the first half of 2006, Tissera has been engaged in large animal experiments of embryonic pig pancreatic xenotransplantation.

In these experiments, conducted by Tissera sponsored research team at the Weizmann Institute of Science, embryonic pig pancreatic tissues, harvested within an optimal gestational time window previously identified by the company's research team, were transplanted into non human primates.

The transplanted tissues were followed for various periods and under various immunosuppressive regimens for survival, structural and functional growth and proliferation within the recipient primates.

A follow-up of sixteen weeks after transplantation showed considerable growth of the engrafted tissue, with persisting significant proliferation of the transplanted cells and a pronounced presence of endocrine elements, notably islet cells, responsible for the production of insulin, the hormone deficient in type I diabetes. No signs of rejection of the pig embryonic pancreatic implants were detected and the tissues were shown to be wholly vascularized by the host primate blood vessels, a fact likely to provide a significant benefit for the successful acceptance and thriving of the graft and for the company's future goal of using minimal immune suppression in transplanted patients. The ability of the transplanted tissues to produce hormones was demonstrated by specific staining for the presence of intra-cellular insulin and glucagon.

The pancreas normally consists of endocrine elements, called islet cells, responsible for insulin and other hormones production, and of exocrine elements, responsible for the production of proteolytic enzymes associated with food digestion.  A major concern associated with pancreatic tissue transplantation is how to avoid destruction of the growing organ by the possible local release of such proteolytic enzymes by the exocrine elements. In previous experiments in mice, the company has shown a marked preference for the development of the endocrine elements, with a progressive disappearance of the exocrine elements. Those results repeated themselves in the present large animal experiment, in which the marked presence of insulin-producing islet cells was accompanied by a complete absence of potentially noxious exocrine elements at sixteen weeks after transplantation.

Following those encouraging results, subsequent large animal model experiments of pig pancreatic xenotransplantation in diabetic recipients have been initiated and are currently conducted by Tissera sponsored research team. Those current studies aim at further demonstrating, in higher animals,  the functional and therapeutic value of the Company's approach, in preparation for the prospective future  conduction of human clinical studies for the treatment of insulin-dependent 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.

Safe Harbor Statement

"Statements in this document that are not purely historical are forward-looking statements. Forward-looking statements in this release include statements regarding our developing technology into a useful product, our moving forward with our plans for trials, and our plans to expand the Company's infrastructure. Actual outcomes and our actual results could differ materially from those in such forward-looking statements. Such statements, including statements regarding freedom to operate, patentability, infringement, clinical trials, involve significant risks and uncertainties and actual results could differ materially from those expressed or implied herein. Factors that could cause such differences include, but are not limited to, risks associated with new product development (including clinical trials outcome and regulatory requirements/actions), competitive risks to marketed products and availability of financing that could cause actual results to differ materially include risks and uncertainties such as the inability to further finance our plans and unforeseen technical difficulties in developing our technology, which could among other things, delay or prevent product development and our planned results. For further risk factors see the Company's 10-KSB filed with the SEC for our latest fiscal year."

 

Contact:

     Tissera, Inc.

     (Investor Relations)

     Dr. Uri Elmaleh

     uri@tissera.com