Leading Eye Institute Will Participate as Site for Both of ACT’s Phase I/II Clinical Trials Using Human Embryonic Stem Cell-Derived RPE Cells for Macular Degeneration
MARLBOROUGH, Mass. — Feb. 15, 2012 – Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that the Wills Eye Institute in Philadelphia has received institutional review board (IRB) approval as a site for the company’s Phase I/II clinical trial for Stargardt’s Macular Dystrophy (SMD), a form of juvenile macular degeneration, using human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells. Earlier this year, the Company also announced that the IRB at Wills Eye Institute had approved the participation of the institution as a site for ACT’s clinical trial for dry age-related macular degeneration (dry AMD).
“We thank Wills Eye Institute once more for providing their IRB and their invaluable contribution to our macular degeneration studies,” said Gary Rabin, ACT’s chairman and CEO. “We are very happy that we can now report that Wills Eye Institute has been approved as a clinical trial site for both our SMD and dry AMD clinical trials. Ranked as one of the best ophthalmology hospitals in the country by U.S. News & World Report, the Wills Eye Institute is a truly world-class institution. Our team is eagerly anticipating working with Dr. Carl Regillo, a renowned retinal surgeon and director of clinical retina research at Wills Eye Institute, as well as a professor of ophthalmology at Thomas Jefferson University, along with the rest of his team as we move forward with these ground-breaking trials.”
The Phase I/II trial for SMD is a prospective, open-label study designed to determine the safety and tolerability of the hESC-derived RPE cells following sub-retinal transplantation into patients with SMD. The trial will ultimately enroll 12 patients, with cohorts of three patients each in an ascending dosage format. Preliminary results relating to both early safety and biological function for the first two patients in the U.S., one SMD patient and one dry AMD patient, were recently reported in The Lancet.
Specific patient enrollment for both trials at the Wills Eye Institute will be determined in the near future. Further information about patient eligibility for the SMD study and the concurrent study on dry AMD is also available on www.clinicaltrials.gov; ClinicalTrials.gov Identifiers: NCT01345006 and NCT01344993.
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.
About hESC-derived RPE Cells
The retinal pigment epithelium (RPE) is a highly specialized tissue located between the choroids and the neural retina. RPE cells support, protect and provide nutrition for the light-sensitive photoreceptors. Human embryonic stem cells differentiate into any cell type, including RPE cells, and have a similar expression of RPE-specific genes compared to human RPE cells and demonstrate the full transition from the hESC state.
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 www.advancedcell.com.
About Wills Eye Institute
Wills Eye Institute is a global leader in ophthalmology, established in 1832 as the nation’s first hospital specializing in eye care. U.S. News & World Report has consistently ranked Wills Eye as one of America’s top three ophthalmology centers since the survey began in 1990. Wills Eye is a premier training site for all levels of medical education. Its resident and post-graduate training programs are among the most competitive in the country. One of the core strengths of Wills is the close connection between innovative research and advanced patient care. Wills provides the full range of primary and subspecialty eye care for improving and preserving sight, including cataract, cornea, retina, emergency care, glaucoma, neuro-ophthalmology, ocular oncology, oculoplastics, pathology, pediatric ophthalmology and ocular genetics, refractive surgery and retina. Ocular Services include the Wills Laser Correction Center, Low Vision Service, and Diagnostic Center. Its 24/7 Emergency Service is the only one of its kind in the region. Wills Eye also has a network of nine multi-specialty, ambulatory surgery centers throughout the tri-state area. To learn more, please visit www.willseye.org.
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.
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