Institutional Review Board (IRB) Approval for Phase I/II Clinical Trial for Dry AMD from Primary Teaching Hospital for Harvard Medical School in Ophthalmology
MARLBOROUGH, Mass. — May 2, 2012 – Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that Massachusetts Eye and Ear (“Mass. Eye and Ear”) has received institutional review board (IRB) approval to be a site for the company’s Phase I/II clinical trial for dry age-related macular degeneration (dry AMD), using human embryonic stem cell (hESC)-derived retinal pigment epithelial (RPE) cells.
“We are delighted to announce that Mass. Eye and Ear will participate as a site for our clinical trial for dry AMD,” said Gary Rabin, ACT’s chairman and CEO. “Dr. Dean Eliott and his team are deeply committed to finding new treatments for preventing blindness, and we very much look forward to tapping into his expertise and insight into the progression of macular degenerative disorders. The primary teaching hospital for ophthalmology at Harvard Medical School, Mass. Eye and Ear is ranked as among the top ophthalmology hospitals in the country by U.S. News & World Report and has a reputation that is unrivaled.”
The Phase I/II trial 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 dry AMD. The trial will ultimately enroll 12 patients, with cohorts of three patients each in an ascending dosage format.
“Dry AMD represents one of the largest unmet medical needs in ophthalmology,” commented Dr. Dean Eliott, M.D. a full time retina surgeon, scientist and Associate Director of the Retina Service at Mass. Eye and Ear. “We appreciate the opportunity to get some first-hand experience with the protocol and be involved with the international team that has been assembled around the U.S. and European trials.”
Founded in 1824, the Massachusetts Eye and Ear Infirmary is an independent specialty hospital affiliated with Harvard Medical School.
Further information about patient eligibility for the dry AMD study is available at www.clinicaltrials.gov; ClinicalTrials.gov Identifier: NCT01344993.
About dry AMD
Degenerative diseases of the retina are among the most common causes of untreatable blindness in the world. Age-related macular degeneration (AMD) is the leading cause of blindness in people over age 60 in the United States, and the vast majority of cases of AMD are of the “dry” form, which is currently untreatable.
About hESC-derived RPE Cells
The retinal pigment epithelium (RPE) is a highly specialized tissue located between the choroid 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 Massachusetts Eye and Ear
Located in Boston, Massachusetts, the Massachusetts Eye and Ear Infirmary is an independent specialty hospital founded in 1824. Mass. Eye and Ear has earned an international reputation for its successful treatment of the most difficult diseases and conditions of the eye, ear, nose, throat, head and neck, and for its outstanding contributions to medical research and education. Mass. Eye and Ear is the primary teaching hospital for Harvard Medical School in ophthalmology and otolaryngology, and trains more than 110 residents and fellows each year in various sub-specialties, including cornea, neuro-ophthalmology, retina, eye pathology, pediatrics, glaucoma, ocular oncology, immunology, head and neck surgery and oncology, pediatric otolaryngology, facial plastics, otology and oto-neurology. For more information, visit www.MassEyeAndEar.org.
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, 2011. 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.
Contact:
Investors:
CEOcast, Inc., James Young, 212-732-4300
Press:
ACT Corporate Communications, Bill Douglass, 646-450-3615
or:
Russo Partners, Martina Schwarzkopf, Ph.D., 212-845-4292
Business Development:
Advanced Cell Technology, Matthew Vincent, Ph.D., [email protected]
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