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Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that it has been issued U.S. Patent Number 7736896, which is broadly directed to processes developed by ACT scientists for the production of retinal pigment epithelial (RPE) cells from human embryonic stem cells (hESCs). Issued with 35 claims, the patent covers what the company believes are the fundamental methods for producing RPE cells from hESCs in a manner that is suitable for use in human patients. The Company expects to use RPE cells in its Phase I trial to treat patients with Stargardt’s Macular Dystrophy (SMD) and in other pre-clinical applications.
“The efficient production of highly pure RPE cell preparations derived from human embryonic stem cells represents the first critical step in the creation of a renewable source of transplantable cells that can be used to target diseases such as Stargardt’s Disease and Age-related Macular Degeneration,” said Robert Lanza, M.D., Chief Scientific Officer of ACT.
“For many of these patients there are no available treatments. We have demonstrated that our stem cell-derived RPE cells can rescue visual function in animals that otherwise would have gone blind. We are anxious to get our clinical trials underway with the hope that these cells will be similarly efficacious in patients.”
“This broad patent covers technology underlying a number of ACT's important platforms,” said William M. Caldwell IV, Chairman and CEO of ACT. “We are optimistic that the culturing processes covered by this new patent, which produce RPE cells with no contamination by hESCs, should establish a formidable barrier to entry for potential competitors.
Our RPE technology is safe, scalable and has tremendous potential for treating many of the 200-plus retinal diseases. This patent should assist us in achieving our objective of becoming one of the dominant players in this potentially very large market.”
The issuance of this patent is the latest in a number of encouraging developments for ACT’s RPE program:
• At the end of last year the Company filed an Investigational New Drug Application with the FDA.
• In February of this year the National Institutes of Health (NIH) proposed expanding its definition of hESCs for funding purposes, potentially benefiting the Company’s RPE program by including its proprietary “embryo-safe” Blastomere technology.
• In March of this year ACT’s RPE cells were granted Orphan Drug Status by the FDA.
• Within the past week ACT received NIH approval for one of its hESC lines (MA135) which now qualifies it for utilizing it for federally-funded R&D programs.
The Company continues to anticipate approval from the FDA to initiate its Phase I/II human clinical trials in the third quarter of this year, with the expectation of treating the first patients in the fourth quarter. The company then plans to take steps toward initiating another clinical trial relating for the use of RPE cells in the treatment of dry Age-Related Macular Degeneration (AMD). At present there is no approved treatment for dry AMD, a $20-30 billion potential market.
About Advanced Cell Technology, Inc.
Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit advancedcell.com/.
Forward-Looking Statements
Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the company’s periodic reports, including the report on Form 10-K for the year ended December 31, 2009.
Forward-looking statements are based on the beliefs, opinions, and expectations of the company’s management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of the company’s management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change.
Contact
Investors:
CEOcast, Inc. for Advanced Cell
Dan Schustack, 212-732-4300
Press:
Gotham Communications, LLC
Bill Douglass, 646-450-3615
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press[.]advancedcell.com 
