MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Advanced Cell Technology, Inc. ("ACT"; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today the dosing of an additional patient in its Phase 1/2 trial for Stargardt’s macular dystrophy using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The patient was treated on Tuesday (Jan. 24) by Steven Schwartz, M.D., Ahmanson Professor of Ophthalmology at the David Geffen School of Medicine at UCLA and retina division chief at UCLA’s Jules Stein Eye Institute. The patient successfully underwent the outpatient transplantation surgery and is recovering uneventfully.
“This is the fourth patient worldwide treated with ACT’s hESC-derived RPE cells,” said Gary Rabin, chairman and chief executive officer of ACT. “We are pleased to be on schedule with our clinical programs to test the safety and tolerability of ACT’s stem cell-derived RPE cells. We are working with the best ophthalmology institutes to evaluate the capacity of our cell therapy which may have the ability to treat a variety of devastating diseases.”
The clinical trial will enroll 12 patients each, with cohorts of three patients each in an ascending dosage format. It is a prospective, open-label study, designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation into patients with Stargardt’s macular dystrophy at 12 months, the study’s primary endpoint. The patient, a 47-year-old male, was treated with the smallest dose of 50,000 cells. The hESC-derived RPE cells are currently also in Phase 1/2 for dry age-related macular degeneration. Preliminary results for the first two patients in each of the Phase 1/2 clinical trials were recently reported in The Lancet.
A third Phase1/2 trial for Stargardt’s macular dystrophy was recently initiated at the Moorfields Eye Hospital in London, treating the first patient on Jan. 20.
Stargardt’s Macular Dystrophy (SMD) is one of the most common forms of macular degeneration in the world. SMD 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 or RPE cell layer.
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.
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, 2010. 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.
James Young, 212-732-4300
ACT Corporate Communications
Bill Douglass, 646-450-3615
Martina Schwarzkopf, Ph.D., 212-845-4292
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INDUSTRY KEYWORDS: Stem Cells Health Biotechnology Clinical Trials Genetics Research Science General Health