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Message #128
From: woodrowwvu
Date: September 22, 2009 11:59:11 AM

Big News - FDA RPE

Advanced Cell Completing Pre-Clinical Activities in Preparation for IND Filing

11:28 am ET 09/22/2009- Business Wire

WORCESTER, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (Advanced Cell, ACT) (OTC: ACTC)

provided an update on pre-clinical activities in preparation of its

first IND filing with the Food and Drug Administration for its retinal

pigment epithelium (RPE) cell program for the treatment of various eye

diseases. In the next few weeks, the Company will be completing the

preclinical work necessary for filing the IND. To date, no adverse

events have occurred in testing. The results will be part of the

submission which Advanced Cell expects to submit to the FDA prior to the

end of the year.



"We are very pleased with the long-term safety and efficacy data," said

Dr. Robert Lanza, ACT's Chief Scientific Officer. "We have carried out

pre-clinical studies using these cells in multiple animal models, and

to-date have not seen any teratoma formation or untoward pathological

reactions. We are optimistic that human embryonic stem cells (hESCs)

will serve as a potentially safe and inexhaustible source of RPE for the

treatment of a range of macular degenerative diseases."



"We are pleased with the progress we have made in preparation for the

FDA submission," said William M. Caldwell IV, Advanced Cell's Chairman

and CEO. "In the retina, compromised RPE function can lead to

deteriorated vision and photoreceptor loss in both age-related macular

degeneration and other forms of degenerative eye disease. We look

forward to further studying the role that our RPE cells can play in

providing a potential solution to this problem."



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.

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