MARLBOROUGH, Mass.--(BUSINESS WIRE)--Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that the Aberdeen Royal Infirmary, the largest of the Grampian University Hospitals in Scotland, has been confirmed as a site for its Phase 1/2 human clinical trial for Stargardt’s Macular Dystrophy (SMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The Phase 1/2 trial is a prospective, open-label study designed to determine the safety and tolerability of the RPE cells following sub-retinal transplantation into patients with SMD.
“A leading medical institution in the United Kingdom, Aberdeen Royal Infirmary is an ideal partner for our European clinical trial for SMD,” said Gary Rabin, chairman and CEO of ACT. “Moreover, we are particularly pleased that the lead investigator is Dr. Noemi Lois, a leading expert in SMD. We continue to forge ties with some of the best eye surgeons and hospitals in the world and work towards bringing this cutting-edge therapy closer to fruition. Our preliminary results to date keep us optimistic that we are on the right path both in terms of our science and the clinical team we are working with, particularly eye surgeons such as Dr. Lois.”
Stargardt's Macular Dystrophy affects an estimated 80,000 to 100,000 patients in the U.S. and Europe, and causes progressive vision loss, usually starting in people between the ages of 10 to 20, although the disease onset can occur at any age. Eventually, blindness results from photoreceptor loss associated with degeneration in the pigmented layer of the retina, the retinal pigment epithelium. “The first Stargardt’s patient to be treated in the U.S. with stem cell-derived RPE cells was a patient who was already legally blind as a consequence of this disease” stated Dr. Robert Lanza M.D., the chief scientific officer at ACT. Preliminary results from the treatment of the first SMD patient were recently reported in The Lancet (23 January 2012) and have been characterized by experts in the field of regenerative medicine as providing early signs of safety and efficacy.
This approved SMD clinical trial that Dr. Lois and her team will participate in is a prospective, open-label study designed to determine the safety and tolerability of RPE cells derived from hESCs following sub-retinal transplantation to patients with advanced SMD, and is similar in design to the FDA-cleared US trial initiated in July 2011.
“It is an honor to have been designated as a site for this path-breaking clinical trial,” said Noemi Lois, M.D., Ph.D. “We could not be more pleased to be a part of this trial for a promising potential new treatment for SMD, using hESC-derived RPE cells.” Dr. Lois is a is a member of the Department of Ophthalmology, NHS Grampian, and associated to the University of Aberdeen, Scotland, United Kingdom. Dr. Lois practices at the Aberdeen Royal Infirmary; she is an Ophthalmologist with special interest in Medical retina and Retinal surgery.
On January 23, 2012, the company announced that the first patient in this SMD clinical trial in Europe had been treated at Moorfields Eye Hospital in London.
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, 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.