Thursday, August 2, 2012
By: Market Watch Wall Street Journal
Patient with Dry Age-Related Macular Degeneration Injected with 100,000 Retinal Pigment Epithelial Cells at Wills Eye Institute in Philadelphia.
MARLBOROUGH, Mass., Aug 02, 2012 (BUSINESS WIRE) — 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
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
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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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
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assume any obligation to update its forward-looking statements if those beliefs,
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SOURCE: Advanced Cell Technology, Inc.