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Press Release Source: Geron
Geron Receives U.S. Patent for Pluripotent Stem Cells Modified for Therapeutic Applications
Tuesday June 10, 7:30 am ET
MENLO PARK, Calif.--(BUSINESS WIRE)--June 10, 2003--Geron Corporation (Nasdaq:GERN - News) announced today that it has been granted U.S. Patent No. 6,576,464, by the U.S. Patent and Trademark Office, with claims directed to pluripotent stem cells that are engineered to permit the elimination of any undifferentiated cells that might remain after production of a batch of differentiated cells. The technology would be used, if needed, to provide an additional level of safety for cell therapies made from human embryonic stem cells ("hES cells").
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"The patent covers stem cells containing a genetic sequence that allows the undifferentiated cells to be specifically eliminated, leaving the differentiated cells unaffected," noted David J. Earp, J.D., Ph.D., Geron's vice president of intellectual property. "In one version, we take advantage of our proprietary telomerase promoter, which causes expression of the genetic sequence in undifferentiated hES cells, but not in differentiated cells made from the hES cells. Because only undifferentiated cells will express the genetic sequence, if any undifferentiated cells remain after a batch of cells has been processed, we can target and remove them from the cell preparation."
Geron is developing hES cell-based approaches to treat heart disease, spinal cord injury, Parkinson's disease, diabetes, and other degenerative diseases. hES cells are unique cells that have the potential to become any type of cell in the body. That potential is highly valuable because it means that the cells can be differentiated under controlled conditions in the laboratory to produce therapeutic cells useful to treat many diseases. However, if the transplanted therapeutic cells also contained undifferentiated cells, they could form various cell types that are not needed for the therapy. This patented technology is one of the ways Geron will ensure that its therapeutic cell preparations do not contain undifferentiated cells.
"Since we made the decision to develop pluripotent stem cell therapeutics, we have focused on safety, efficacy and scalability," said Thomas B. Okarma, Ph.D., M.D., Geron's president and chief executive officer. "We have made significant progress in all three areas. We developed feeder-free growth techniques to enable scalable growth of hES cells. We and our collaborators are now testing the safety and efficacy of hES cell-derived cardiomyocytes, dopaminergic neurons, oligodendrocytes and hematopoietic cells in animal models. One specific safety issue we considered at the beginning of our work was the potential for undifferentiated cells remaining in the differentiated cell preparations used for therapy. Geron scientists developed this technology as a method to ensure that we could remove any undifferentiated cells that remained. We are becoming increasingly proficient at producing highly purified populations of differentiated cells, so these methods would serve as back-up safety technology."
Worldwide, Geron currently owns or has licensed over 100 patents and patent applications relating to pluripotent stem cells.
Geron is a biopharmaceutical company focused on developing, and commercializing therapeutic and diagnostic products for applications in oncology and regenerative medicine, and research tools for drug discovery. Geron's product development programs are based upon three patented core technologies: telomerase, human embryonic stem cells and nuclear transfer.
This news release may contain forward-looking statements made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements in this press release regarding future applications of Geron Corporation's technology constitute forward-looking statements involving risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, need for regulatory approvals or clearances, and the 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 on March 31, 2003.
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