ACT Treats 10th Patient in Embryonic Stem Cell Trials for Macular Degeneration
Third Stargardt's Patient in EU Trial Treated with RPE Cells Derived from Human
Embryonic Stem Cells at Moorfields Eye Hospital in London
MARLBOROUGH, Mass., Jul 30, 2012 (BUSINESS WIRE) -- Advanced Cell Technology,
Inc. ("ACT"; OTCBB: ACTC), a leader in the field of regenerative medicine, today
announced treatment of the final patient in the first patient cohort in its Phase
1/2 clinical trial for Stargardt's macular dystrophy (SMD) using retinal pigment
epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The
surgery was performed on Friday, July 27 at Moorfields Eye Hospital in London,
the same site as the first two treatments, by a team of surgeons led by Professor
James Bainbridge, consultant surgeon at Moorfields and Chair of Retinal Studies
at University College London. The outpatient transplant surgery was performed
successfully without any complications, and the patient is recovering
uneventfully. This is the tenth patient overall to now be treated with the RPE
cell therapy developed by the company.
"Our European trial is making very steady progress, having now completed
enrollment of the first patient cohort," commented Gary Rabin, chairman and CEO.
"We are very encouraged and look forward to receiving clearance to initiate the
treatment of the second patient cohort in the coming weeks."
The Phase 1/2 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. It
is similar in design to the U.S. trial for SMD that was initiated in July 2011.
"This is a significant month for the company," continued Mr. Rabin. "One year ago
we treated the first of our patients in our two U.S. clinical trials. The
one-year follow-up for those initial patients indicates that the improvements in
visual acuity we initially reported have in fact persisted now for a year.
Indeed, we are consistently observing improvements in subjective and objective
visual acuity for patients being treated at the various clinical centers involved
in our trials. Again, these trials are still at very early stages, but these
preliminary results indicate that we are on the right track."
The European Medicines Agency's (EMA) Committee for Orphan Medicinal Products
(COMP) has officially designated ACT's human embryonic stem cell (hESC)-derived
retinal pigment epithelial (RPE) cells as an orphan medicinal product for the
treatment of 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.
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 |
