Advanced Cell Technology Announces Completion of Pre-IND Meeting with
the FDA for RPE Therapy for the Treatment of Retinal Degenerative
Disease
Feb 1, 2008
Company Demonstrates Progress Toward Moving its Second Cell Therapy
into Human Clinical Trials
LOS ANGELES — Advanced Cell Technology, Inc. (OTCBB:ACTC) today
announced that it completed discussions with the Food and Drug
Administration (FDA) regarding its retinal pigmented epithelial (RPE)
cell therapy through a type B, pre-Investigational New Drug (pre-IND)
meeting concerning the regulatory pathway and requirements to file an
IND to initiate human clinical trials. ACT is working with the agency
to fulfill the FDA's requirements to bring its RPE cell therapy into
human clinical trials for the treatment of retinal degenerative
diseases such as Retinitis Pigmentosa, Stargardt's disease, and dry
age-related macular degeneration (AMD). The RPE cells are derived
from human embryonic stem cells created from ACT single blastomere
cell lines under GMP compliant conditions. ACT is moving forward with
its characterized RPE manufacturing process to complete the final
stages of the company's preclinical testing. Should ACT successfully
file an IND for its RPE therapy, the company plans to move forward
with Phase I human clinical trials. ACT's Myoblast therapy, an
autologous adult stem cell therapy for the treatment of heart
failure, has already successfully completed Phase I human clinical
trials and is moving into Phase II human clinical trials shortly.
Studies of the company's proprietary RPE cells have shown that the
therapy may ultimately provide effective treatment of degenerative
retinal disorders including macular degeneration, which represents a
$28 billion dollar market. AMD affects more than 30 million people
worldwide and is the leading cause of blindness in people over 60 in
the United States. The prevalence of AMD begins to increase after the
age of 50. Approximately 15% of people over 75 have the condition. To
date, AMD patients have had few if any effective therapies for
treatment; thus, the need for novel therapies is clear.
In November at Neuroscience 2007, researchers at Oregon Health and
Science University (OHSU) presented results of a study that used ACT
RPE cells manufactured under GMP conditions (21CFR211) at the
company's facility in Worcester, Massachusetts. The RPE cells were
thoroughly characterized and cryo-preserved and shipped to
researchers at OHSU for transplantation. The conclusions drawn by
researchers were that visual function can be rescued and preserved in
this animal model of disease utilizing ACT's GMP-manufactured human
ES-derived RPE cells with a functional dose threshold and that these
cells may provide an effective donor cell source to rescue
photoreceptors in conditions like AMD, where RPE function is
compromised.
The next step in the development of the program will be to complete
several safety studies utilizing the GMP-manufactured RPE cells.
Pilot studies to date have shown the cells to be safe, well
tolerated, and non-migratory. The Good Laboratory Practice (GLP)
compliant studies are required prior to filing an IND. The safety
studies will include several key areas of examination, including,
tumorigenicity potential, cell tolerability, cell survival, general
safety, and potential for biodistribution.
"We are pleased to complete this key milestone as we move our RPE
program toward the clinic," said William Caldwell, IV, Chairman and
CEO of Advanced Cell Technology. "Based upon our cell
characterization data, pharmacology studies, and the overall safety
profile, we are excited by the prospects for this program and the
potential to treat a large unmet medical need. The successful
completion of our Pre-IND meeting represents another step forward
towards the filing of the IND for our RPE Program and ultimately
bringing the therapy to the bedside. We are one step closer to
bringing our second stem cell therapy to patients in need."
About Advanced Cell Technology, Inc.
Advertisement
Is Your Computer Slower Than When You Bought It?
Cure for Memory Loss Found
Computer Slowing Down? What to Do About It
Advanced Cell Technology, Inc. is a biotechnology company applying
embryonic stem cell technology in the emerging field of regenerative
medicine. The company operates facilities in Alameda, California and
Worcester, Massachusetts.
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,
s," 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-QSB for the quarter ended September 30, 2006. 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.
Media: Chad Griffin Consulting, Inc. Jordan Markwith, 310-888-3523 or
Investors: CEOcast, Inc. Dan Schustack, 212-732-4300
http://www.centreda
«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»«¤»¥«¤»§«¤»¥«¤»§«¤»¥«
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
StemCells subscribers may also be interested in these sites:
Children's Neurobiological Solutions
http://www.CNSfoundation.org/
Cord Blood Registry
http://www.CordBlood.com/at.cgi?a=150123
The CNS Healing Group
http://groups.yahoo.com/group/CNS_Healing
____________________________________________
«¤»¥«¤»§«¤»¥«¤»§«¤»¥«¤»«¤»¥«¤»§«¤»¥«¤»§«¤»¥«
¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯¯
Change settings via the Web (Yahoo! ID required)
Change settings via email: Switch delivery to Daily Digest | Switch format to Traditional
Visit Your Group | Yahoo! Groups Terms of Use | Unsubscribe
__,_._,___
No comments:
Post a Comment