ACT’s European Clinical Trial Advances to First Patient Treatment with Higher Dosage of Embryonic Stem Cell-Derived Retinal

  ACT’s European Clinical Trial Advances to First Patient Treatment with
  Higher Dosage of Embryonic Stem Cell-Derived Retinal Pigment Epithelial
  Cells

        First Patient of Second Cohort Injected with 100,000 RPE Cells

Business Wire

MARLBOROUGH, Mass. -- October 22, 2012

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 European clinical trial for
Stargardt’s Macular Dystrophy (SMD). The patient was injected with 100,000
human embryonic stem cell-derived retinal pigment epithelial (RPE) cells, as
compared with 50,000 cells in the three patients comprising the first cohort.
The outpatient transplantation surgery was performed successfully and the
patient is recovering uneventfully.

“Our progress continues in our European clinical trial and both our trials in
the U.S., as seen most recently with last week’s announcement of treatment of
the second patient in the second patient cohort of our U.S. trial for SMD,”
said Gary Rabin, chairman and CEO of ACT. “As I mentioned last week, we have
mapped out the series of patients to complete the second cohort of both our
trials for SMD, as well as for our trial for dry age-related macular
degeneration (dry AMD), pending DSMB review, and we anticipate generating
patient data at a faster pace.”

Initiated in January of this 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. The company is concurrently
conducting another trial for SMD and one for dry AMD, both in the U.S.

“We are very gratified to be initiating the first treatment of the second
patient cohort in our European clinical trial, having just started it this
year,” commented Robert Lanza, M.D., ACT’s chief scientific officer. “Our two
U.S. trials also continue to move steadily forward.”

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 www.clinicaltrials.gov,
with the following Identifiers: NCT01469832 (E.U. SMD), NCT01345006 (U.S.
SMD), and NCT01344993 (dry AMD).

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.

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.

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
 
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