| [April 24, 2012] |
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ACT Announces Data and Safety Monitoring Board (DSMB) Approval to Increase RPE Dosage for Stargardt's Disease Patients in U.S. Trial
MARLBOROUGH, Mass. --(Business Wire)--
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, have recently
authorized the Company to move forward with enrollment and treatment of
additional patients with Stargardt's disease (SMD). In the U.S. SMD
trial, ACT will screen and enroll patients for the second cohort, who,
in keeping with trial protocol, will be injected with 100,000 retinal
pigment epithelial (RPE) cells - as compared with the 50,000 cell dose
used in the patients of the first cohort. The Company has also been
approved to treat the final two patients to round out the initial dosing
arm in its European trial. The use of pluripotent stem cells to derive
RPE cells, and the use of the resulting RPE cells for treating a wide
range of macular degenerative disorders, are covered by a robust patent
portfolio owned by ACT, including a number of issued broad patents in
key world markets.
"DSMB authorization to move to the next higher dosage of cells in our
U.S. clinical trial and complete the treatment of the first cohort of
patient in our European trial represents yet another significant
advancement for our clinical programs," commented Gary Rabin, chairman
and CEO of ACT. "We are pleased with the pace of progress and the
continued finding of safety amongst the participants in both the U.S.
and European trials. The results so far have been encouraging, and with
our SMD programs having been granted 'orphan' medicinal product
designation in both the U.S. and Europe, we look forward to eventually
reaching a stage at which we can further avail ourselves of all the
regulatory and financial benefits this designation brings."
The three procedures comprising the first cohort of patients in the U.S.
SMD trial were all conducted at University of California at Los Angeles
(UCLA), 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. The first procedure in the E.U. trial
was conducted at Moorfields Eye Hospital in London, by a team of
surgeons led by Professor James Bainbridge, consultant surgeon at
Moorfields and Chair of Retinal Studies at University College London.
"We are gratified to be moving to the next stage in both of our SMD
trials," commented Robert Lana, M.D., ACT's chief scientific officer.
"We remain very encouraged by the preliminary data in the first four SMD
patients treated with the lowest dose of RPE cells at UCLA and
Moorfields Eye Hospital. We are doubling the number of cells that will
be transplanted in the next group of patients in the U.S. trial. We will
be anxious to see if the higher dosage of RPE cells will impact visual
function and photoreceptor rescue."
ACT is conducting three clinical trials in the U.S. and Europe using
hESC-derived RPE cells to treat forms of macular degeneration. Each
trial will enroll a total of 12 patients, with cohorts of three patients
each in an ascending dosage format. 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 (News - Alert) or Stargardt's macular dystrophy (SMD) at 12
months, the study's primary endpoint. On January 20, 2012, the first SMD
patient enrolled in the Company's U.K. clinical trial was
treated at Moorfields Eye Hospital in London. The final patient of
the first cohort in the company's SMD trial in the U.S. was
treated on February 13, 2012.
Further information about patient eligibility for the dry AMD study and
the concurrent study on SMD is also available on www.clinicaltrials.gov;
ClinicalTrials.gov Identifiers: NCT01345006, NCT01469832 and NCT01344993.
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
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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
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assurance that the Company's clinical trials will be successful.

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