ACT Announces First Stargardt Patient Treated With Higher Dosage of Embryonic
Stem Cell-Derived Retinal Pigment Epithelial Cells
Patient Injected with 100,000 RPE Cells at Wills Eye Institute
MARLBOROUGH, Mass., Jul 12, 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 its U.S. clinical trial for Stargardt's Macular Dystrophy (SMD). The
surgery was performed on Wednesday, July 11 at Wills Eye Institute in
Philadelphia, by a surgical team lead by Carl D. Regillo, MD, FACS, director of
the Wills Eye Clinical Retina Research Unit, attending surgeon in the Wills Eye
Retina Service at the Wills Eye Institute, and professor of ophthalmology at
Thomas Jefferson University. In keeping with trial protocol, the patient was
injected with 100,000 human embryonic stem cell-derived retinal pigment
epithelial (RPE) cells, as compared with the 50,000 cell dose used in the three
patients of the first cohort. The outpatient transplantation surgery was
performed successfully and the patient is recovering uneventfully.
"It is very gratifying to have second cohort, higher-dosage patient treatment
underway in our U.S. clinical trial for SMD," commented Gary Rabin, chairman and
CEO of ACT. "We are also pleased to be working with Dr. Regillo and his team at
Wills Eye Institute, a truly first-class institution that is ranked as one of the
best ophthalmology hospitals in the country by U.S. News & World Report."
Initiated in July of last year, the Phase I/II trial is designed to determine the
safety and tolerability of hESC-derived RPE cells following sub-retinal
transplantation in patients with SMD at 12 months, the study's primary endpoint.
It will involve a total of 12 patients, with cohorts of three patients each in an
ascending dosage format. As part of its RPE clinical program, the company is
concurrently conducting a clinical trial for dry age-related macular degeneration
and second trial for SMD in the United Kingdom.
"Doubling the cell dosage marks an important milestone in our clinical programs,"
said Robert Lanza, MD, ACT's chief scientific officer. "We look forward to
continued progress and safety findings in the coming months, in both our U.S. and
European trials."
Further information about patient eligibility for ACT's SMD study and the
concurrent studies in the U.S. and Europe (for dry age-related macular
degeneration and SMD, respectively) are available at
clinicaltrials.gov, with the following Identifiers: NCT01345006 (U.S.
SMD), NCT01344993 (dry AMD), and NCT01469832 (E.U. SMD).
About Stargardt's Disease
Stargardt's disease or Stargardt's Macular Dystrophy is a genetic disease that
causes progressive vision loss, usually starting in children between 10 to 20
years of age. Eventually, blindness results from photoreceptor loss associated
with degeneration in the pigmented layer of the retina, called the retinal
pigment epithelium, which is the site of damage that the company believes the
hESC-derived RPE may be able to target for repair after administration.
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.
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Statements in this news release regarding future financial and operating results,
future growth in research and development programs, potential applications of our
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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
Press:
ACT Corporate Communications, Bill Douglass, 646-450-3615
or:
Russo Partners, Martina Schwarzkopf, Ph.D., 212-845-4292 |
