ACT Announces First Dry AMD Patient Treated with Higher Dosage of Embryonic Stem Cell-Derived RPE Cells
Patient with Dry Age-Related Macular Degeneration Injected with 100,000 Retinal Pigment Epithelial Cells at Wills Eye Institute in Philadelphia
MARLBOROUGH, Mass. — Aug. 2, 2012 – Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of regenerative medicine, today announced treatment of the fourth patient, the first in the second patient cohort, in the company’s Phase I/II clinical trial for dry age-related macular degeneration (dry AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The surgery was performed on Wednesday, Aug. 1 at Wills Eye Institute in Philadelphia, by a surgical team lead by Carl D. Regillo , M.D., Chief of the Wills Eye Institute Retina Service, and professor of ophthalmology at Thomas Jefferson University. The patient was injected with 100,000 hESC-derived RPE cells and is recovering uneventfully.
“We are very pleased to have the second dose cohort in both of our U.S. clinical trials underway,” commented Gary Rabin, chairman and CEO of ACT. “We are encouraged by our ongoing progress in all three of our clinical trials using our hESC-derived RPE cells to treat forms of macular degeneration. We have not observed any complications or side effects from the stem cell-derived RPE cells, and we will continue to monitor the patients for safety, tolerability and efficacy of this therapy.”
The dry AMD trial is one of three clinical trials being carried out by the company in the U.S. and in Europe. Each trial will enroll 12 patients, with cohorts of three patients in an ascending dosage format. These trials are prospective, open-label studies, designed to determine the safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation into patients with dry AMD or Stargardt's macular dystrophy (SMD) at 12 months, the study’s primary endpoint. Preliminary results from the two U.S. trials were reported in The Lancet earlier this year.
“Doubling the cell dosage in both our U.S. trials is an important step forward in our clinical programs,” said Robert Lanza, M.D., ACT’s chief scientific officer. “We anticipate continued progress and safety findings in both our U.S. trials as well as our concurrent European trial.”
“Dry AMD is the most common cause of vision loss in patients over 50 years and affects around 30 million people worldwide,” said Dr. Regillo. “Dry AMD is a form of macular degeneration with no approved drug treatment available to date. ACT’s hESC-derived RPE cells could address the unmet medical need of combating dry AMD and other macular degenerations such as Stargardt’s disease. We are looking forward to analyzing the safety and efficacy data.”
Further information about patient eligibility for ACT’s dry AMD study and the
concurrent studies in the U.S. and the E.U. for SMD is available at www.clinicaltrials.gov, with the following Identifiers: NCT01344993 (dry AMD), NCT01345006 (U.S. SMD), and NCT01469832 (E.U. SMD).
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 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, and refractive surgery. 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
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