ACT Announces Data and Safety Monitoring Board (DSMB) Approval to Complete Second Patient Cohort in Clinical Trial for Dry AMD

  ACT Announces Data and Safety Monitoring Board (DSMB) Approval to Complete
  Second Patient Cohort in Clinical Trial for Dry AMD

  Patients Five and Six to be Treated with 100,000 Human Embryonic Stem Cell
         (hESC)-Derived RPE Cells, Completing Second Cohort of Trial

Business Wire

MARLBOROUGH, Mass. -- November 01, 2012

Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of
regenerative medicine, announced today that the Data and Safety Monitoring
Board (DSMB), an independent group of medical experts closely monitoring the
Company’s three ongoing clinical trials, has authorized the Company to move
forward with enrollment and treatment of two additional patients with dry
age-related macular degeneration (dry AMD). ACT will screen and enroll the
second and third patients of the three-patient second cohort in the trial. Per
trial protocol, each patient will be injected with 100,000 human embryonic
stem cell (hESC)-derived retinal pigment epithelial (RPE) cells.

“Dry AMD represents one of the largest unmet medical needs in the world, and
we are thrilled to be making steady progress in our clinical trial for this
condition,” commented Gary Rabin, ACT’s chairman and CEO. “We are well on our
way to the halfway point of all three of our clinical trials. We also recently
secured DSMB approval to complete the second cohort of our two trials for
Stargardt’s Macular Dystrophy.”

ACT is conducting three clinical trials in the U.S. and Europe using
hESC-derived RPE cells to treat forms of macular degeneration, dry AMD and
Stargardt’s Macular Dystrophy (SMD). Each trial will enroll a total of 12
patients, with cohorts of three patients each in an ascending dosage format,
from 50,000 to 200,000 hESC-derived RPE cells. These trials are prospective,
open-label studies, designed to determine the safety and tolerability of
hESC-derived RPE cells following sub-retinal transplantation into patients
with dry AMD or SMD at 12 months, the study’s primary endpoint.

“This authorization to treat the next two patients in the second,
higher-dosage cohort of our trial for dry AMD represents a notable milestone
for our clinical programs,” commented Robert Lanza, M.D., ACT’s chief
scientific officer. “We look forward to treating these two patients and moving
on to the third cohort in good time.”

Further information about patient eligibility for ACT’s SMD studies in the
U.S. and E.U. as well as its dry AMD study in the U.S. are available
atwww.clinicaltrials.gov,with the following Identifiers: NCT01345006 (U.S.
SMD), NCT01469832 (E.U. SMD), and NCT01344993 (dry AMD).

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
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
Press:
ACT Corporate Communications
Bill Douglass, 646-450-3615
or
Russo Partners
Martina Schwarzkopf, Ph.D., 212-845-4292
 
Press spacebar to pause and continue. Press esc to stop.