BUSINESS WIRE
WORCESTER, Mass.--(BUSINESS WIRE)--Advanced Cell Technology, Inc. (OTCBB:ACTC),
a biotechnology company applying cellular technology in the field of
regenerative medicine, announced today that it has received notification
from the US Food and Drug Administration (FDA) that the Agency is
currently drafting a response to the Company relating to the
Investigational New Drug (IND) Application it filed in November seeking
clearance to initiate a Phase I/II multicenter study using embryonic
stem cell derived retinal cells to treat patients with Stargardt’s
Macular Dystrophy (SMD). ACT is currently on clinical hold pending a
response from the Agency, which it expects within the next few weeks.
“We look forward to receiving the FDA's response and working with them
to address any questions that they may have,” said William M. Caldwell
IV, Advanced Cell’s Chairman and CEO. “Although ACT has taken important
steps to advance our RPE program during the last several years, we
anticipate the need for further discussions with the Agency before
clinical trials can proceed.”
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 http://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.