ACT Treats First Patient with Better Vision in Clinical Trial for Stargardt’s Macular Dystrophy

  ACT Treats First Patient with Better Vision in Clinical Trial for
  Stargardt’s Macular Dystrophy

Patient Injected with 100,000 human embryonic stem cell-(hESC) derived Retinal
                           Pigment Epithelial Cells

Business Wire

MARLBOROUGH, Mass. -- April 15, 2013

Advanced Cell Technology, Inc. (“ACT”; OTCBB: ACTC), a leader in the field of
regenerative medicine, today announced treatment of the first patient in
patient cohort 2a, consisting of patients with better vision, in its U.S.
clinical trial for Stargardt’s Macular Dystrophy (SMD), a form of juvenile
macular degeneration. The surgery was performed on Thursday, April 11 atWills
Eye Institutein Philadelphia, by JosephMaguire, M.D., aco-investigator on
the trial. The protocol is overseen by Principle Investigator,Carl D.
Regillo, M.D.,Chief of the Wills Eye Institute Retina Service, and professor
of ophthalmology at Thomas Jefferson University. The patient was injected with
100,000 human embryonic stem cell-derived retinal pigment epithelial (RPE)
cells. As the company announced on Jan. 22, patients with a visual acuity of
20/100 are eligible for enrollment in cohort 2a in the two U.S. clinical
trials, for SMD and dry age-related macular degeneration (dry AMD). By
treating patients earlier in the course of the disease, the Company believes
that the amended patient protocol may have a more significant impact on
photoreceptor rescue and visual function. In previous protocols, only SMD
patients with a visual acuity no better than hand movement in the treated eyes
and dry AMD patients with a visual acuity of 20/400 were eligible. The
outpatient transplantation surgery was performed successfully and the patient
is recovering uneventfully.

“We are pleased to have commenced treatment of the first patient in the cohort
with better vision of our U.S. SMD trial,” commented Gary Rabin, chairman and
CEO of ACT. “Treatment of these patients will be critical in defining the
future direction of our therapy. The data that we gather from these cases is
instrumental in further understanding retinal disease impact, allowing us to
improve clinical trial design for future phases and the ultimate
commercialization strategy for our RPE program.”

Initiated in July 2011, the two Phase I trials are designed to determine the
safety and tolerability of hESC-derived RPE cells following sub-retinal
transplantation in patients with SMD and dry AMD at 12 months, the studies’
primary endpoint. Both trials will involve a total of 16 patients, with
cohorts of three patients each in an ascending dosage format, as well as four
patients with better vision, receiving 100,000 hESC-derived RPE cells. The
company is concurrently conducting a second trial for SMD in Europe.

“We continue to be encouraged by the steady progress of our trials,” said
Robert Lanza, M.D., chief scientific officer. “We are particularly pleased to
have treated our first patient with better vision, and we look forward to
seeing the results and to treating the first dry AMD patient with better
vision, as well.”

Further information about patient eligibility for ACT’s SMD study and the
concurrent studies in the U.S. and Europe (for dry age-related macular
degeneration and SMD, respectively) are available at www.clinicaltrials.gov,
with the following Identifiers: NCT01345006 (U.S. SMD), NCT01344993 (dry AMD),
and NCT01469832 (E.U. SMD).

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
http://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 the report on Form 10-K for
the year ended December 31, 2012. 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:

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
 
Press spacebar to pause and continue. Press esc to stop.