WORCESTER, Mass., Jan 08, 2010 (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.
SOURCE: Advanced Cell Technology, Inc.
CONTACT:
Advanced Cell Technology, Inc. Rita Parker, 508-756-1212 x654 or CEOcast, Inc. for Advanced Cell Dan Schustack, 212-732-4300
Copyright Business Wire 2010
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KEYWORD: United States
North America
Massachusetts
INDUSTRY KEYWORD: Stem Cells
Health
Biotechnology
Clinical Trials
Optical
Pharmaceutical
FDA
SUBJECT CODE: Product/Service
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