Leading Eye Institute to Participate in ACT's Embryonic Stem Cell Clinical Trial
for Macular Degeneration
Wills Eye Institute receives IRB approval to treat dry-AMD using ACT's
hESC-derived retinal pigment epithelial (RPE) cells
MARLBOROUGH, Mass., Jan 17, 2012 (BUSINESS WIRE) -- Advanced Cell Technology,
Inc. ("ACT"; OTCBB: ACTC), a leader in the field of regenerative medicine, today
announced that the Wills Eye Institute in Philadelphia has received institutional
review board (IRB) approval as a site for the Phase 1/2 clinical trial for dry
age-related macular degeneration (dry AMD) using human embryonic stem cell
(hESC)-derived retinal pigment epithelial (RPE) cells.
"The participation of Wills Eye Institute in this trial will significantly
enhance our clinical program," said Robert Lanza, M.D., ACT's chief scientific
officer. "Wills Eye Institute is the oldest eye-care facility in the United
States and is consistently ranked as one of the best ophthalmology hospitals in
the country by the U.S. News & World Report. We are looking forward to working
with Dr. Regillo and his team to address the unmet medical needs of degenerative
diseases of the retina. With this latest approval, the company continues to
assemble a clinical team that includes the best eye hospitals and surgeons in the
world in our effort to find an effective therapy for this devastating eye
disease."
The Phase 1/2 trial for dry AMD 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. Which patients will be enrolled at the Wills Eye Institute will be
determined in the near future.
"Degenerative diseases of the retina often lead to a significant visual
impairment," said Carl Regillo, M.D., director of clinical retina research at
Wills Eye Institute and professor of ophthalmology at Thomas Jefferson
University. "Replacing lost or damaged cells with functional and healthy cells
may provide a treatment option that could slow vision loss, and perhaps even
reverse the effects of disease. We are looking forward to collaborating with ACT
to evaluate the potential of the stem cell-derived RPE cells for debilitating
diseases such as Stargardt's macular dystrophy and dry AMD."
Dry AMD, or "central geographic atrophy," is the "dry" form of advanced
age-related macular degeneration. Dry AMD occurs when the light-sensitive cells
(photoreceptors) in the macula slowly break down, gradually blurring central
vision in the affected eye. Over time, as less of the macula functions, central
vision is gradually lost in the affected eye, often progressing to blindness. The
loss of photoreceptors is a direct result of a preceding degeneration of the
retinal pigment epithelial (RPE) layer of cells just below the retina. As many as
30 million people in the United States and Europe suffer from macular
degeneration, which represents a $25-30 billion worldwide market that has yet to
be effectively addressed. Approximately 10% of people ages 66 to 74 will have
symptoms of macular degeneration, the vast majority suffering from the "dry" form
of AMD -- which is currently untreatable. The prevalence increases to 30% in
patients 75 to 85 years of age.
"We are honored to have the opportunity to work with one of the foremost eye care
centers in the world", said Gary Rabin, chairman and chief executive officer of
ACT. "This clinical trial represents the culmination of years of innovation and
hard work by ACT's scientific team. The whole world is focused on our trials,
most especially patients suffering from dry AMD and other forms of macular
degeneration. Wills Eye Institute has a strong tradition of innovation and
discovery, and we are excited at their participation in bringing this
cutting-edge technology through the clinic."
Additional details about these studies, for which the Jules Stein Institute at
the University of California, Los Angeles has also received IRB approval, can be
found at clinicaltrials.gov; ClinicalTrials.gov Identifier: NCT01345006
and NCT01344993.
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
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
willseye.org.
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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
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commercialization of potential products, protection of our intellectual property,
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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
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circumstances should change. Forward-looking statements are based on the beliefs,
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should change. There can be no assurance that the Company's clinical trials will
be successful.
SOURCE: Advanced Cell Technology, Inc.
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