Message #70 From:
NewsBot Date: April 11, 2008 08:30:01 AM
Advanced Cell Technology's Executive Invited to Present Today to FDA Advisory Committee on Cellular Tissue Therapies
Advanced Cell Technology, Inc. (OTCBB: ACTC) 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 ResearchAdvisory 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 onCellular
Therapies Derived from Human Embryonic Stem Cells Scientific
Considerations for Pre-Clinical Safety Testing. Other companies invited
to present include Geron Corporation (NASDAQ: GERN) 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 at http://www.advancedcell.com/conference-presentations
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 at http://www.fda.gov/ohrms/dockets/ac/cber08.html#CellularTissueGene
Therapies (Due to its length, this URL may need to be copied/pasted
into your Internet browser's address field. Remove the extra space if
one exists).
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 www.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-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.
