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Geron Scientists and Collaborators Differentiate Human Embryonic Stem Cells Into Insulin-Producing Islet-Like Clusters.


Studies Demonstrate Feasibility of Producing Therapeutic Cells From hESCs for Treatment of Diabetes

MENLO PARK, Calif. -- Geron Corporation (Nasdaq:GERN v. t. 1. To grin or yawn. ) today reported that its scientists and collaborators at the University of Alberta have differentiated human embryonic stem cells (hESCs) into islet-like clusters (ILCs) that secrete insulin in response to elevated glucose levels. The studies demonstrate the feasibility of producing therapeutic cell types from hESCs for the treatment of diabetes.

To be published in the August issue of Stem Cells, which is available now for online viewing in Stem Cells Express at http://stemcells.alphamedpress.org/papbyrecent.dtl, the paper describes studies showing how the researchers differentiated hESCs into cell clusters containing the main cellular components of the islets of Langerhans islets of Langerhans: see pancreas. . The islets of Langerhans are structures in the pancreas that are responsible for regulating and producing insulin in response to changing glucose concentrations and are targets for autoimmune destruction or dysfunction in Type I Diabetes Type I diabetes
Also called juvenile diabetes. Type I diabetes typically begins early in life. Affected individuals have a primary insulin deficiency and must take insulin injections.

Mentioned in: Diabetic Ketoacidosis
.

"These studies show that the islet-like clusters contain the major cellular components of islets and are sensitive to glucose, the key sugar to which they must respond to be therapeutically beneficial," stated Anish Majumdar, Ph.D., the senior author of the paper. "Our major goal moving forward is to improve the purity, yield and maturational status of these cells to induce normoglycemia normoglycemia /nor·mo·gly·ce·mia/ (-gli-sem´e-ah) euglycemia.normoglyce´mic

nor·mo·gly·ce·mi·a
n.
See euglycemia.
 in animal models of diabetes."

Geron Corporation was granted U.S. Patent No. 7,033,831 in April 2006 covering the production of insulin-secreting cells from hESCs as well as two U.K. patents covering similar production methods. Geron also has a worldwide exclusive commercial license covering hESC-derived islets from the Wisconsin Alumni Research Foundation The Wisconsin Alumni Research Foundation is the nonprofit technology transfer office of the University of Wisconsin-Madison. It is a significant source of research support, independent of federal grants. .

Geron's scientists and collaborators produced ILCs containing individual cells types that express insulin, glucagon glucagon (gl`kəgŏn), hormone secreted by the α cells of the islets of Langerhans, specific groups of cells in the pancreas. It tends to counteract the action of insulin, i.e.  and somatostatin Somatostatin

A naturally occurring regulatory peptide that carries out numerous functions in the human body, including the inhibition of growth hormone secretion from the anterior pituitary gland.
, three of the major hormones produced by islet b, a and d cells, respectively. Further analysis of the insulin-producing cells indicates they also produce c-peptide, a peptide cleaved cleaved (klevd) split or separated, as by cutting.  upon secretion of the precursor of insulin, indicating that insulin was actually produced, and not absorbed, by the cells. Approximately 2%-8% of the differentiated cells contain insulin and c-peptide and their insulin content was higher than that of fetal islets.

The ILCs functioned to secrete insulin in response to elevated glucose levels. Cells within the ILCs contained secretory granules Granules
Small packets of reactive chemicals stored within cells.

Mentioned in: Allergic Rhinitis, Allergies
 characteristic of those seen in islet b cells. In cell culture, the ILCs produced c-peptide and insulin when exposed to higher concentrations of glucose with the kinetics of an immature islet.

The protocol to produce the ILCs drives hESCs through a series of cell culture steps that mimic the progressive differentiation stages during development of the pancreas in humans. Other pancreatic cell types resembling those of the exocrine pancreas were also observed during the differentiation process. The protocol does not utilize serum or feeder cells of any kind, underscoring the scalability of the process.

Originally developed at the University of Alberta, the Edmonton Protocol provides the proof of concept that transplantation of purified cadaveric islets can significantly reduce the need for insulin in patients with advanced Type 1 Diabetes type 1 diabetes
n.
See diabetes mellitus.
. Problems limiting the accessibility of transplantation therapy for diabetes patients are the poor availability of organs from cadavers and the eventual failure of the grafts, which often require replacement and chronic immunosuppression immunosuppression

Suppression of immunity with drugs, usually to prevent rejection of an organ transplant. Its aim is to allow the recipient to accept the organ permanently with no unpleasant side effects.
.

"The Edmonton Protocol provides significant evidence that transplantation of primary islets can be used to successfully reduce the need for insulin in patients with Type 1 Diabetes," said Thomas B. Okarma, Ph.D., M.D., Geron's president and chief executive officer. "It is the work published today that demonstrates the potential of human embryonic stem cells to enable the ready availability of uniform, functional islet cells for therapeutic administration."

Geron is developing first-in-class biopharmaceuticals for the treatment of cancer and chronic degenerative diseases, including spinal cord injury Spinal Cord Injury Definition

Spinal cord injury is damage to the spinal cord that causes loss of sensation and motor control.
Description

Approximately 10,000 new spinal cord injuries (SCIs) occur each year in the United States.
, heart failure, diabetes and HIV/AIDS HIV/AIDS Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome . The company is advancing an anti-cancer drug and a cancer vaccine that target the enzyme telomerase through multiple clinical trials. Geron is also the world leader in the development of human embryonic stem cell-based therapeutics, with its spinal cord injury treatment anticipated to be the first product to enter clinical development. For more information, visit www.geron.com.

This news release may contain forward-looking statements made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. Investors are cautioned that such forward-looking statements in this press release regarding potential applications of Geron's human embryonic stem cell technology constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Geron's periodic reports, including the quarterly report on Form 10-Q for the quarter ended March 31, 2007.
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Copyright 2007, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Date:May 17, 2007
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