By GlobeNewswire, October 02, 2013, 08:00:00 AM EDT
Episomes Reprogram Adult Tissue Cells to Stem Cell State, Opening the Door to Therapeutic Research and Clinical Use
MADISON, Wis., Oct. 2, 2013 (GLOBE NEWSWIRE) -- Cellular Dynamics International (CDI) (Nasdaq:ICEL), announced today that the U.S. Patent and Trademark Office (PTO) issued Patent No. 8,546,140 entitled "Methods for the Production of iPS Cells Using Non-Viral Approach" on October 1. The newly issued patent relates to the method by which adult tissue cells, such as blood or skin, are reprogrammed into induced pluripotent stem (iPS) cells by the insertion of episomal vectors. This method is used by CDI for the creation of its iCell® and MyCell® Products. This episomal reprogramming patent has a term extending through May 2030.
Episomal vectors used in reprogramming are circular pieces of DNA that, when introduced into adult tissue cells, express genes known as reprogramming factors that drive the adult tissue cells back to a stem cell state, before then exiting the cell. This non-integrating methodology alleviates major safety concerns over the potential use of iPS-derived cells as therapeutics and removes a significant barrier for applying the technology in a clinical setting. Episomal reprogramming already has been performed to Good Manufacturing Practice (GMP) standards, a prerequisite for use of these cells in clinical applications.
In comparison, the original reprogramming method, published in 2007, uses viral vectors to insert four genes into the adult tissue cell's DNA. These genes integrate directly into the cell's genome. Concerns have arisen over the potential risks associated with this insertion of foreign DNA into the cell's genome, including insertion defects and errors that could lead to tumors.
Invented by CDI scientists, the episomal reprogramming method was first published in 2009 by James Thomson, V.M.D., Ph.D., founder and chief scientific officer and Junying Yu, Ph.D., senior director, advanced development programs at CDI, in Science. Since this publication, over 275 peer-reviewed scientific papers have cited this seminal paper on the episomal reprogramming method, indicating it is one of the most widely used methods for producing iPSCs.
"What is particularly noteworthy with the episomal method is that foreign DNA is not integrated into the genome of the cell during the reprogramming process," said Thomson. "Thus, the original biological integrity of the cell is maintained. This reprogramming method has been widely adopted by leaders in the field to create differentiated tissue cell types, such as cardiomyocytes, neurons and hepatocytes, to better understand human disease, test the efficacy and safety of drug candidates and most importantly develop therapeutic applications."
Bob Palay, chairman and chief executive officer of CDI, said, "The episomal reprogramming method has been widely adopted for research into therapeutic applications of iPS cell technology. Dr. Thomson's and CDI's goal has been to make stem cell technology widely available and easy to use. Toward that end we launched an episomal reprogramming kit, including Episomal iPSC Reprogramming Vectors, Vitronectin, and Essential 8™ Medium, that we began distributing through Life Technologies in 2012. The issuance of this patent to CDI ensures the continued broad availability of this critical technology."
CDI also holds an exclusive license from the Wisconsin Alumni Research Foundation (WARF) to the only other episomal reprogramming patent, which covers methodology that was invented at the University of Wisconsin by Thomson and Junying Yu.
Frequently asked questions regarding this patent, licensing information and episomal reprogramming technology l can be found on CDI's website, www.cellulardynamics.com/tech.
About Cellular Dynamics International, Inc.
Cellular Dynamics International, Inc. (CDI) is a leading developer of induced pluripotent stem cell technologies for in vitro drug development, stem cell banking and in vivo cellular therapeutic research. CDI harnesses its unique manufacturing technology to produce differentiated tissue cells in industrial quality, quantity and purity from any individual's induced pluripotent stem cell line created from a standard blood draw. CDI was founded in 2004 by Dr. James Thomson, a pioneer in human pluripotent stem cell research at the University of Wisconsin-Madison. CDI's facilities are located in Madison, Wisconsin, with a second facility in Novato, California. See www.cellulardynamics.com. Follow us on Twitter @CellDynamics or www.twitter.com/celldynamics
To the extent that statements contained in this press release are not descriptions of historical facts regarding Cellular Dynamics International, Inc., including the impact of the issuance of U.S. Patent No. 8,546,140 and episomal reprogramming, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "believe," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our product development efforts, actual results, performance or achievements to differ materially from those expressed or implied by the forward-looking statements. Cellular Dynamics undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see Cellular Dynamic's quarterly report on Form 10‑Q filed with the Securities and Exchange Commission on August 29, 2013.
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