|[February 11, 2013]
ACT's Clinical Partner Receives FDA Approval to Initiate Clinical Trial Using the Company's hESC-derived Cells to Treat Severe Myopia
MARLBOROUGH, Mass. --(Business Wire)--
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 (News - Alert)) 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 ndpoint.
Preliminary results from the U.S. Stargardt's and Dry Age Related
Macular Degeneration trials were reported
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
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.
Statements in this news release regarding future financial and
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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
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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
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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
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assurance that the Company's clinical trials will be successful.
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