BioTime Presents Updated OpRegen® Phase I/IIa Trial Data at AAO
November 15 2017 - 8:00AM
Business Wire
- There were no treatment-related serious
adverse events after 15 months
- Signs of engraftment and cell survival
have been maintained
BioTime, Inc. (NYSE American: BTX), a late stage clinical
biotechnology company focused on developing and commercializing
products addressing degenerative diseases, today announced that an
abstract related to one of its lead programs, OpRegen® for dry-AMD,
was presented at the annual American Academy of Ophthalmology (AAO)
in New Orleans, Louisiana, on November 14, 2017.
Dr. Eyal Banin (Hadassah-Hebrew University Medical Center,
Jerusalem, Israel), one of the principal investigators
participating in the study, presented data from the ongoing
open-label, dose escalation study. The abstract presented was
titled, “Phase 1 and 2a Study of Human Stem Cell – Derived
Retinal Pigment Epithelial Cells Transplanted Subretinally in
Advanced Dry-Form AMD Patients.”
OpRegen® is composed of differentiated retinal pigment
epithelium cells derived from human stem cells under xeno-free
conditions. Observations of the ongoing PI/IIa open-label study and
the results to date show that both the surgical procedure used to
inject the OpRegen® cells, as well as OpRegen®, were well
tolerated. OpRegen® showed continued long-term safety through 15
months and there were no treatment-related systemic serious adverse
events to date. In addition to safety and tolerability, imaging
suggests signs of engraftment and cell survival.
“We believe that administration of OpRegen® cells may ultimately
prove to be a potential therapeutic option for dry-AMD subjects and
are currently actively enrolling additional subjects to further
understand the possibility it represents for these patients,”
commented Dr. Eyal Banin.
To view the actual presentation, please refer to the events and
presentation section of the BioTime website,
http://investor.biotimeinc.com/phoenix.zhtml?c=83805&p=irol-calendar.
About OpRegen®
OpRegen®, which is being studied for the treatment of the dry
form of AMD, consists of a suspension of Retinal Pigment Epithelial
(RPE) cells that are delivered subretinally during a simple
intraocular injection. RPE cells are essential components of the
back lining of the retina, and function to help nourish the retina
including photoreceptors. A proprietary process that drives the
differentiation of human pluripotent stem cells is used to generate
high purity OpRegen® RPE cells. OpRegen® RPE cells are
also “xeno-free," meaning that no animal products are used at any
point in the derivation and production process. The avoidance of
the use of animal products eliminates some potential safety
concerns. Preclinical studies in rats have shown that following a
single subretinal injection of OpRegen®, the cells can rapidly
organize into its natural monolayer structure in the subretinal
space and survive throughout the lifetime of the animal.
OpRegen® is designed to be an “off-the-shelf” allogeneic
(non-patient specific) product. Unlike treatments that require
multiple, frequent injections into the eye, it is expected that
OpRegen® would be administered in a single procedure.
OpRegen® was granted Fast Track designation
from the FDA, which allows more frequent interactions
with the agency, and eligibility for accelerated approval and
priority review. OpRegen® is a registered trademark
of Cell Cure Neurosciences Ltd., a majority-owned subsidiary
of BioTime, Inc.
About BioTime, Inc.
BioTime is a late stage clinical biotechnology company
focused on developing and commercializing products addressing
degenerative diseases. The Company’s current clinical programs are
targeting three primary sectors, aesthetics, ophthalmology and cell
and drug delivery. Its clinical programs are based on two platform
technologies: pluripotent cells, which can become any type of cell
in the human body, and cell/drug delivery. Renevia®, a cell
delivery product, met its primary endpoint in an EU pivotal
clinical trial for the treatment of facial lipoatrophy in HIV
patients earlier this year. Submission for approval of
Renevia® in the EU is expected to be early 2018, with possible
approval and commercial launch in 2018. There were no device
related serious adverse events reported. OpRegen®, a retinal
pigment epithelium transplant therapy, is in a Phase I/IIa
multicenter trial for the treatment of dry age-related macular
degeneration, the leading cause of blindness in developing
countries. There were no related serious adverse events
reported. BioTime also has significant equity holdings in
two publicly traded companies, Asterias Biotherapeutics,
Inc. (NYSE American: AST) andOncoCyte Corporation (NYSE
American: OCX), and a private company, AgeX Therapeutics,
Inc.
BioTime common stock is traded on the NYSE American and
TASE under the symbol BTX. For more information, please
visit www.biotime.com or connect with the company
on Twitter, LinkedIn, Facebook, YouTube,
and Google+.
To receive ongoing BioTime corporate communications,
please click on the following link to join the Company’s email
alert list: http://news.biotime.com.
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version on businesswire.com: http://www.businesswire.com/news/home/20171115005559/en/
Investor Contact:BioTimeDavid Nakasone,
510-871-4188Dnakasone@biotime.comMedia Contact:JQA Partners,
Inc.Jules Abraham, 917-885-7378jabraham@jqapartners.com
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