Patients with Better Vision to be Enrolled in ACT's Clinical Trials for Macular
Degeneration
Patients with 20/100 Vision Will Now be Eligible for Enrollment, Expanding
Patient Base and Potentially Accelerating Pace of Trials
MARLBOROUGH, Mass., Jan 22, 2013 (BUSINESS WIRE) -- Advanced Cell Technology,
Inc. ("ACT"; OTCBB: ACTC or the "Company"), a leader in the field of regenerative
medicine, announced today that it is amending the patient treatment protocol for
the remainder of the Company's Phase I clinical trials for Stargardt's macular
dystrophy (SMD) and dry age-related macular degeneration (dry AMD) currently
being conducted in the U.S. and will also submit an amendment in Europe for the
SMD trial being conducted there. Patients with better vision, a visual acuity of
20/100, will be eligible for enrollment in the remainder of the trials. By
treating patients earlier in the course of the disease, the Company believes that
the amended patient protocol will 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.
"Having recently reached the halfway point in our three clinical trials for
macular degeneration, now is an opportune time to pursue modifications which
could help accelerate the pace of all three trials," said Gary Rabin, chairman
and CEO. "The advanced age of many of our enrolled patients has tended to limit
the pace at which we are able to enroll and treat them, since other, unrelated
health complications tend to come up more frequently in the elderly. Patients
with better vision tend to be younger on average."
The Company plans to institute the amended patient protocols upon receipt of
Institutional Review Board (IRB) approval from each of the clinical sites, for
the second half of all the clinical trials.
"We are pleased to be able to expand patient enrollment in all three of our
ongoing clinical trials," said Robert Lanza, M.D., ACT's chief scientific
officer. "Not only does it have the potential to accelerate the road to the
completion of Phase I, but having a more diverse patient population could also
provide additional clinical insights."
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
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, 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 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.
cts.businesswire.com
SOURCE: Advanced Cell Technology, Inc.
Investors:
CEOcast, Inc.
James Young, 212-732-4300
or
Press:
ACT
Bill Douglass, 646-450-3615
Corporate Communications,
or:
Russo Partners
Martina Schwarzkopf, Ph.D., 212-845-4292 |
