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Advanced Cell Technology, Inc. : ACT Initiates Higher-Dosage Patient Treatment in European Clinical Trial for Macular Degeneration

04/23/2013 | 08:40am US/Eastern

First Stargardt's Patient in EU Trial Treated with 150,000 RPE Cells Derived from Human Embryonic Stem Cells

Advanced Cell Technology, Inc. ("ACT"; OTCBB: ACTC), a leader in the field of regenerative medicine, today announced treatment of the first patient in the third dosage cohort, and seventh patient overall, in its European Phase I clinical trial for Stargardt's macular dystrophy (SMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The patient was injected with 150,000 hESC-derived RPE cells, as compared with the 100,000-cell dose used in patients of the second cohort. The surgery was performed on Friday, April 19, without any complications, and the patient is recovering uneventfully.

"Europe represents a huge potential market for us, the world's largest after the U.S., so we are particularly pleased to now be past the halfway point in all three of our clinical trials on both continents," commented Gary Rabin, chairman and CEO of ACT. "SMD affects as many as 100,000 patients in the U.S. and Europe. Moreover, as previously announced, the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP) officially granted our hESC-derived RPE cells orphan medicinal product designation for the treatment of SMD. We expect this will provide a number of benefits once our SMD treatment has made the transition from the clinic to the bedside, including reduced fees and protection from competition."

The Phase 1/2 trial is designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation in patients with SMD at 12 months, the study's primary endpoint. It will involve a total of 12 patients, with cohorts of three patients each in an ascending dosage format.

"We are pleased to have now moved into the second-half of all our clinical trials for macular degeneration," said Robert Lanza, M.D., chief scientific officer. "We are eagerly anticipating advancing toward the final cohort in all three trials."

About Stargardt's Disease

Stargardt's disease or Stargardt's Macular Dystrophy is a genetic disease that causes progressive vision loss, usually starting in children between 10 to 20 years of age. Eventually, blindness results from photoreceptor loss associated with degeneration in the pigmented layer of the retina, called the retinal pigment epithelium, which is the site of damage that the company believes the hESC-derived RPE may be able to target for repair after administration.

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-K for the year ended December 31, 2012. 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. There can be no assurance that the Company's clinical trials will be successful.

Investors:
CEOcast, Inc.
James Young, 212-732-4300
or
Press:
ACT Corporate Communications
Bill Douglass, 646-450-3615
or:
Russo Partners
David Schull, 858-717-2310


© Business Wire 2013
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