ACT’s Clinical Partner Receives FDA Approval to Initiate Clinical Trial Using the Company’s hESC-derived Cells to Treat

  ACT’s Clinical Partner Receives FDA Approval to Initiate Clinical Trial
  Using the Company’s hESC-derived Cells to Treat Severe Myopia

  UCLA’s Investigator IND Application for Embryonic Stem Cell-Based Clinical
 Trial to Evaluate Safety and Tolerability in Patients with Severe Myopia, or
                       Nearsightedness, Approved by FDA

Business Wire

MARLBOROUGH, Mass. -- February 11, 2013

Advanced Cell Technology, Inc.’s (“ACT”; OTCBB: ACTC or the “Company”),
clinical partner, the University of California, Los Angeles (UCLA), has
received approval of its Investigator Investigational New Drug (IND)
Application with the US Food and Drug Administration (FDA), led by Steven
Schwartz, M.D., Ahmanson Professor of Ophthalmology at the David Geffen School
of Medicine at UCLA and retina division chief at UCLA's Jules Stein Eye
Institute, to initiate a Phase I/II study using ACT’s retinal pigment
epithelial (RPE) cells derived from human embryonic stem cells (hESCs) to
treat myopic macular degeneration (MMD, or myopia), commonly known as
nearsightedness. The primary focus of the study will be to evaluate the safety
in patients with severe myopia of the type that causes fissures in the RPE
layer of the eye. Dr. Schwartz is the principal investigator in each of ACT’s
two Phase I/II clinical trials for Stargardt's macular dystrophy and dry
age-related macular degeneration (dry AMD) using RPE cells derived from hESCs.
The approval was announced by Dr. Schwartz in his presentation at Bascom
Palmer Eye Institute’s tenth annual angiogenesis meeting, “Angiogenesis,
Exudation, and Degeneration 2013,” on Saturday, February 9 in Miami, Fla.

“We are encouraged by Dr. Schwartz’s keen interest in the evaluation of ACT’s
RPE cells in potentially treating myopia,” commented Gary Rabin, chairman and
CEO of ACT. “We are pleased to be on track to broaden the scope of our RPE
program with the initiation of the new Investigator IND. Nearsightedness is a
very common condition, worldwide, and it is estimated that roughly 30% of
cases are high, or severe, myopia.”

The myopia clinical trial will follow a similar protocol as the company’s
three other human clinical trials in the U.S. and Europe using hESC-derived
RPE cells to treat forms of macular degeneration. The trial will enroll a
total of 12 patients, with cohorts of three patients in an ascending dosage
format. The trial is a prospective, open-label study designed to determine the
safety and tolerability of hESC-derived RPE cells following sub-retinal
transplantation into patients with myopia at 12 months, the study’s primary
endpoint.

Preliminary results from the U.S. Stargardt’s and Dry Age Related Macular
Degeneration trials were reported in The Lancet earlier this year.

“We look forward to initiating the clinical trial,” commented Dr. Schwartz.
“Myopic degeneration is an increasingly important global cause of permanent
central vision loss for which there is no accepted treatment. Applying our key
learnings from the ongoing ACT-sponsored stem cell trials allows the research
promise of regenerative medicine to include myopic vision loss.”

Robert Lanza, M.D., ACT’s chief scientific officer, commented, “Myopia is one
of the most common medical ailments in the world and myopic patients have a
higher risk of permanent vision loss due to complications such as fissures in
the RPE layer of the eye. We are anticipating Dr. Schwartz’s evaluations,
potentially leading to a treatment for those patients at high risk of vision
loss from this condition.”

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.

About the Jules Stein Eye Institute at UCLA

Established in 1966, the Jules Stein Eye Institute at UCLA represents the
culmination of a dream shared by ophthalmologist, businessman and
philanthropist Dr. Jules Stein and his wife, Doris, of creating a
world-renowned center dedicated to the preservation of vision and the
prevention of blindness. The Institute’s comprehensive programs for the care
of patients with eye disorders, research in the vision sciences, education in
the field of ophthalmology and outreach to the community, coupled with its
state-of-the art facilities, have brought national and international
recognition to UCLA and the Institute, as it continues its mission to advance
ophthalmology worldwide.

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:

ACT:
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
UCLA:
Jules Stein Eye Institute
Elaine Schmidt, 310-794-2272
eschmidt@mednet.ucla.edu
 
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