Advanced Cell Technology, Inc. ("ACT"; OTCBB:
ACTC), a leader in the field of regenerative medicine, today
announced treatment of the first patient in the third dosage cohort, and
seventh patient overall, in its European Phase I clinical trial for
Stargardt's macular dystrophy (SMD) using retinal pigment epithelial
(RPE) cells derived from human embryonic stem cells (hESCs). The patient
was injected with 150,000 hESC-derived RPE cells, as compared with the
100,000-cell dose used in patients of the second cohort. The surgery was
performed on Friday, April 19, without any complications, and the
patient is recovering uneventfully.
"Europe represents a huge potential market for us, the world's largest
after the U.S., so we are particularly pleased to now be past the
halfway point in all three of our clinical trials on both continents,"
commented Gary Rabin, chairman and CEO of ACT. "SMD affects as many as
100,000 patients in the U.S. and Europe. Moreover, as previously
announced, the European Medicines Agency's (EMA) Committee for
Orphan Medicinal Products (COMP) officially granted our hESC-derived RPE
cells orphan medicinal product designation for the treatment of SMD. We
expect this will provide a number of benefits once our SMD treatment has
made the transition from the clinic to the bedside, including reduced
fees and protection from competition."
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.
"We are pleased to have now moved into the second-half of all our
clinical trials for macular degeneration," said Robert Lanza, M.D.,
chief scientific officer. "We are eagerly anticipating advancing toward
the final cohort in all three trials."
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 http://www.advancedcell.com.
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, 2012.
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.
James Young, 212-732-4300
Bill Douglass, 646-450-3615
David Schull, 858-717-2310