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News for 'ACTC' - (ACT Announces UCLA Institutional Review Board (IRB) Approval of its Phase 1/2 Clinical Trials using hESC-Derived RPE Cells for the Treatment of Macular Degeneration UCLA's Jules Stein Eye Institute to be a Site for Phase 1/2 Trials for Stargardt's Macular Dystrophy (SMD) and Dry Age-related Macular Dystrophy (Dry AMD))
MARLBOROUGH, Mass., April 28, 2011 /PRNewswire via COMTEX/ -- Advanced Cell
Technology, Inc. ("ACT"; OTCBB: ACTC), a leader in the field of regenerative
medicine, announced today that the Jules Stein Eye Institute at the University
of California, Los Angeles (UCLA) has received institutional review board (IRB)
approval to be a site for its Phase 1/2 human clinical trials for Stargardt's
Macular Dystrophy (SMD) and Dry Age-Related Macular Degeneration (Dry AMD) using
retinal pigment epithelial (RPE) cells derived from human embryonic stem cells
"It is only appropriate that an institution with the global stature of UCLA's
Jules Stein Eye Institute would be a site for the first-ever clinical trials
using embryonic-derived stem cells to treat diseases of the eye, and we could
not be more pleased," said Gary Rabin, interim chairman and CEO of ACT. "One of
the world's foremost institutions for ophthalmology-related clinical trials, the
institute represents an ideal partner for both trials, and we are eagerly
anticipating starting them as soon as possible."
The Phase 1/2 trials will be prospective, open-label studies designed to
determine the safety and tolerability of theRPEcells following sub-retinal
transplantation into patients with SMD and DryAMD.
"The outstanding scientific and leadership teams at ACT are extremely
impressive. Together, our collaboration has led to both FDA and IRB permission
to commence these trials. This signals the long-awaited societal and
institutional 'green light' to take what will hopefully be a huge step forward
into the realm of human stem cell science. I am honored to be leading the
clinical collaboration," said Steven Schwartz, MD, Ahmanson Professor and Retina
Division Chief, at UCLA's Jules Stein Eye Institute and Principal Investigator
of the trials.
Enrollment criteria for patient selection will be posted at
[url]www.ClinicalTrials.gov[/url] in coming days.
About Dry AMD and SMD
Degenerative diseases of the retina are among the most common causes of
untreatable blindness in the world. As many as thirty million people in the
United States and Europe suffer from macular degeneration, which represents a
$25-30 billion worldwide market that has yet to be effectively addressed.
Approximately 10% of people ages 66 to 74 will have symptoms of macular
degeneration, the vast majority the "dry" form of AMD - which is currently
untreatable. The prevalence increases to 30% in patients 75 to 85 years of age.
Stargardt's Macular Dystrophy (SMD) is one of the most common forms of macular
degeneration in the world. SMD 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 or RPE cell layer.
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
About the Jules Stein Eye Institute
Established in 1966, the Jules Stein Eye Institute 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 the Institute and UCLA. Many have contributed
to this tradition of excellence and many more will carry it forward as the
Institute continues its mission to advance ophthalmology worldwide.
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, 2010.
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.
Investors:CEOcast, Inc., James Young, 212-732-4300
Press:ACT Corporate Communications, Bill Douglass, 646-450-3615or:Russo
Partners, Martina Schwarzkopf, Ph.D., 212-845-4292
SOURCE Advanced Cell Technology, Inc.
Copyright (C) 2011 PR Newswire. All rights reserved
INDUSTRY KEYWORD: HEA
SUBJECT CODE: TRI