Advanced Cell Prepares for IND Filing

Fri. September 25, 2009; Posted: 12:09 AM

Sep 25, 2009 (Close-Up Media via COMTEX) -- ACTC | Quote | Chart | News | PowerRating -- Advanced Cell Technology, Inc. has 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 a release, the Company noted that in the next few weeks, it 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."

Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the field of regenerative medicine.

((Comments on this story may be sent to health@closeupmedia.com))

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