ALAMEDA, Calif.-- (BUSINESS WIRE)--Advanced Cell Technology, Inc. (OTCBB: ACTC - News)announced today that Jonathan H. Dinsmore Ph.D., Senior Vice President - Regulatory and Clinical, has been invited to present to the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research Advisory Committee on Cellular, Tissue and Gene Therapies. Dr. Dinsmore will deliver a presentation today titled, "Safety Considerations for the Clinical Application of Human Embryonic Stem Cells” to the FDA panel, which will convene at the Hilton Hotel in Gaithersburg, Maryland. The presentation is scheduled for 10 a.m. eastern time. The panel is expected to conduct hearings on Cellular Therapies Derived from Human Embryonic Stem Cells Scientific Considerations for Pre-Clinical Safety Testing. Other companies invited to present include Geron Corporation (NASDAQ: GERN - News) and Novocell, Inc.
During Dr. Dinsmore's presentation, he is expected to discuss cell sourcing, manufacturing and delivery of human embryonic stem cells. He will also present certain conclusions from pre-clinical activities surrounding the company's retinal pigmented epithelial (RPE) cell therapy. Advanced Cell recently completed discussions with the FDA regarding this program through a type B, pre-Investigational New Drug (pre-IND) meeting concerning the regulatory pathway and requirements to file an IND to initiate human clinical trials. The entire presentation will be available on the company's web site by blank> clicking here after 11 a.m. eastern time today.
"We are honored that the FDA has invited us to participate in this panel, which could be influential in shaping the clinical pathway for the testing of embryonic stem cells,” said William M. Caldwell IV, Chairman and CEO of Advanced Cell Technology, Inc. "As one of the few stem cell companies that is preparing for later-stage clinical trials, we are pleased that we will be able to share our views with FDA executives and other distinguished members of the scientific community on the safety issues surrounding human embryonic stem cell development.”
Additional details on the FDA meeting may be found by blank>clicking here to the FDA website.
About Advanced Cell Technology, Inc.
Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the emerging field of regenerative medicine. The company operates facilities in California and Massachusetts.
For more information, visit "http://www.advancedcell.com":http://www.advancedcell.com.
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-QSB for the quarter ended September 30, 2007. 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.
CEOcast, Inc. for Advanced Cell Technology
Daniel Schustack, 212-732-4300