Advanced Cell Technology Announces Final Patient Treated in Stargardt’s Macular Degeneration Phase 1 Trial in the United Ki...
September 25 2014 - 9:17AM
Business Wire
Trial Designed to Show Safety of Retinal
Pigment Epithelium Cells (RPE) derived from Human Embryonic Stem
Cells
Advanced Cell Technology, Inc. (“ACT”; OTCBB:ACTCD), a
leader in the field of regenerative ophthalmology, announced today
that it has completed treatment of the final patient in its U.K.
based Phase 1 clinical trial for Stargardt’s macular degeneration
(SMD). The successful transplantation of the Company’s proprietary
RPE cells in the last patient of twelve represents the completion
of the enrollment stage of this trial. The trial is a prospective,
open-label study designed to determine the safety and tolerability
of the Company’s RPE cell therapy following sub-retinal
transplantation into patients.
“The completion of enrollment and treatment of all patients in
the Phase 1 portion of our U.K. clinical trial is a significant
milestone for ACT and its RPE programs,” said Eddy Anglade, M.D.,
ACT’s Chief Medical Officer. “We look forward to analyzing the data
as we continue to advance our clinical programs. To date, no cell
or immune-related adverse events have been reported in any of the
patients treated; indicating that our RPE cell therapy appears to
be safe and well-tolerated at all of the doses planned for the
study.”
As previously announced, the Company is working with regulatory
agencies in the U.S. and Europe to commence multi-site Phase 2
clinical trials to further examine the efficacy and safety of its
RPE cell therapy in patients suffering from SMD, as well as dry
age-related macular degeneration (AMD).
Paul K. Wotton, Ph.D., President and Chief Executive Officer,
said, “This accomplishment is important for the Company, and I
would like to thank our investigators and all of the patients who
participated in this study. We will continue to advance the
development of our novel cell therapy products that may ultimately
help patients who suffer from debilitating diseases, such as SMD
and AMD, both significant and unmet medical needs”
Further information regarding ACT’s SMD study in Europe is
available at www.clinicaltrials.gov, with the following Identifier:
NCT01469832.
About Advanced Cell Technology, Inc.
Advanced Cell Technology, Inc., (ACT) is a clinical stage
biotechnology company focused on the development and
commercialization of regenerative medicine and cell therapy
technology. The company’s most advanced products are in clinical
trials for the treatment of dry age-related macular degeneration,
Stargardt’s macular degeneration and myopic macular degeneration.
ACT’s preclinical programs involve cell therapies for the treatment
of other ocular disorders and for diseases outside the field of
ophthalmology, including autoimmune, inflammatory and wound
healing-related disorders. The company’s intellectual property
portfolio includes pluripotent stem cell platforms – hESC and
induced pluripotent stem cell (iPSC) – and other cell therapy
research programs. 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 our report on
Form 10-K for the year ended December 31, 2013 and our report on
Form 10-Q for the three and six months ended June 30, 2014.
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 or other development programs will be
successful.
Investors:Westwicke PartnersJohn Woolford,
443-213-0506john.woolford@westwicke.comorPress:Russo PartnersDavid
Schull, 858-717-2310david.schull@russopartnersllc.com