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 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
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
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
willseye.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.
SOURCE: Advanced Cell Technology, Inc.
Investors:
CEOcast, Inc.
James Young, 212-732-4300
or
Press:
ACT Corporate Communications
Bill Douglass, 646-450-3615
or
Russo Partners
Martina Schwarzkopf, Ph.D., 212-845-4292 |
