MARLBOROUGH, Mass.--(BUSINESSWIRE)--
Second Site for First Human Embryonic Stem Cell Trial in
Europe
Advanced Cell Technology, Inc. (“ACT”;
OTCBB: ACTC), a leader in the field of regenerative
medicine, announced today that the Aberdeen Royal Infirmary,
the largest of the Grampian University Hospitals in Scotland,
has been confirmed as a site for its Phase 1/2 human clinical
trial for Stargardt’s Macular Dystrophy (SMD) using retinal
pigment epithelial (RPE) cells derived from human embryonic
stem cells (hESCs). The Phase 1/2 trial is a prospective,
open-label study designed to determine the safety and
tolerability of the RPE cells following sub-retinal
transplantation into patients with SMD.
“A leading medical institution in the United Kingdom, Aberdeen
Royal Infirmary is an ideal partner for our European clinical
trial for SMD,” said Gary Rabin, chairman and CEO of ACT.
“Moreover, we are particularly pleased that the lead
investigator is Dr. Noemi Lois, a leading expert in SMD. We
continue to forge ties with some of the best eye surgeons and
hospitals in the world and work towards bringing this
cutting-edge therapy closer to fruition. Our preliminary
results to date keep us optimistic that we are on the right
path both in terms of our science and the clinical team we are
working with, particularly eye surgeons such as Dr. Lois.”
Stargardt's Macular Dystrophy affects an estimated 80,000 to
100,000 patients in the U.S. and Europe, and causes progressive
vision loss, usually starting in people between the ages of 10
to 20, although the disease onset can occur at any age.
Eventually, blindness results from photoreceptor loss
associated with degeneration in the pigmented layer of the
retina, the retinal pigment epithelium. “The first Stargardt’s
patient to be treated in the U.S. with stem cell-derived RPE
cells was a patient who was already legally blind as a
consequence of this disease” stated Dr. Robert Lanza M.D., the
chief scientific officer at ACT. Preliminary results from the
treatment of the first SMD patient were recently
reported in
The Lancet (23 January 2012) and have been
characterized by experts in the field of regenerative medicine
as providing early signs of safety and efficacy.
This approved SMD clinical trial that Dr. Lois and her team
will participate in is a prospective, open-label study designed
to determine the safety and tolerability of RPE cells derived
from hESCs following sub-retinal transplantation to patients
with advanced SMD, and is similar in design to the FDA-cleared
US trial initiated in July 2011.
“It is an honor to have been designated as a site for this
path-breaking clinical trial,” said Noemi Lois, M.D., Ph.D. “We
could not be more pleased to be a part of this trial for a
promising potential new treatment for SMD, using hESC-derived
RPE cells.” Dr. Lois is a is a member of the Department of
Ophthalmology, NHS Grampian, and associated to the University
of Aberdeen, Scotland, United Kingdom. Dr. Lois practices at
the Aberdeen Royal Infirmary; she is an Ophthalmologist with
special interest in Medical retina and Retinal surgery.
On January 23, 2012, the company
announced that the first patient in this SMD clinical trial
in Europe had been treated at Moorfields Eye Hospital in
London.
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
http://www.advancedcell.com.
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, 2010.
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.
Contact
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
or
Business Development:
Advanced Cell Technology
Matthew Vincent, Ph.D., 508-756-1212 x324
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