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Tissera Reports Extension of Agreement for Sponsored Research at the Weizmann Institute of Science.

Tuesday, 29 May 2007

 

Tissera, Inc. (OTCBB: TSSR – News) reports it has signed with Yeda, the Technology Transfer arm of the Weizmann Institute of Science, an agreement extending the  research and development activities performed for the company at the Institute by one more additional year, up to April 9, 2008. This will be the fifth consecutive year of implementation of the company research at the Weizmann Institute.

 

The main objective of the experiments planned for this additional research period is to further advance the ongoing preclinical studies being performed on primate models of type I (insulin-dependent) diabetes mellitus, as a preparation for the initiation of human clinical studies on diabetic patients.

 

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 (STZ) 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.   

 

As part of the results obtained so far, a progressive post transplantation reduction of the insulin amounts required for maintenance of blood sugar levels has been observed, together with the demonstration of gradual increase of  blood insulin levels, suggestive of   insulin production, which might be attributed to the growing pancreatic graft, though the pig origin of this insulin remains to be verified.

 

Tissue examination 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 of great importance for the successful acceptance and thriving of the graft. The ability of the transplanted tissues to produce hormones was demonstrated by specific staining for the presence of intra-cellular insulin and glucagon.

 

A significant difficulty encountered in those experiments has to do with the dosage of the immune suppression treatment initially given for the prevention of rejection, which was found to be eventually lethal in several cases. This issue is and will be carefully addressed in the company's current and future experiments, by a well-planned and fined tuned progressive reduction of administered immune suppression doses.

 

Altogether, those are positive and encouraging preliminary data. The current experiments and those planned for the coming research year are designed to further validate and strengthen the results achieved so far. The research team seeks to clarify whether the tendency of reduction of insulin requirements persists over time and whether complete weaning from exogenous insulin dependence can be achieved, under an appropriate immune suppression regimen, acceptable for human treatment. Progress in this endeavor will constitute a crucial step in advancing the company towards its next goal of getting an authorization 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:

www.tissera.com

 

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.

Dr. Uri Elmaleh 

uri@tissera.com

+972-52-5716669

 

SOURCE: Tissera, Inc.

 
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