Data from BioTime's OpRegen® and Vision Restoration Programs to Be Presented at ARVO 2018
February 15 2018 - 7:00AM
Business Wire
- OpRegen® is in a Phase I/IIa clinical
trial for dry-AMD
- Vision Restoration – Our 3-Dimensional
Retinal Tissue Program
BioTime, Inc. (NYSE American: BTX), a late-stage, clinical
biotechnology company developing and commercializing products
addressing degenerative diseases, today announced that two
abstracts have been accepted and will be presented at the upcoming
Association for Research in Vision and Ophthalmology (ARVO)
meeting taking place from April 29th – May 3rd, 2018, in
Honolulu, Hawaii.
"BioTime is looking forward to presenting at ARVO, the largest
and most respected eye and vision research organization in the
world," said Adi Mohanty, Co-Chief Executive Officer at BioTime.
"This marks the 3rd consecutive year that we have been accepted to
present at ARVO. Each year we have been able to share positive data
from OpRegen®, our RPE transplant product, as it has progressed
from preclinical studies through successive clinical cohorts."
The scheduled times (noted in local Hawaii time) and location of
the two BioTime data presentations at the Hawaii Convention Center
are as follows:
OpRegen® Poster Presentation
- Title: Phase I/IIa Clinical
Trial of Human Embryonic Stem Cell (hESC)-Derived Retinal Pigmented
Epithelium (RPE, OpRegen®) Transplantation in Advanced Dry Form
Age-Related Macular Degeneration (AMD): Interim Results
- Presentation Number – Posterboard
Number: 77-A0124
- Session Title: AMD and Retinal
Therapies Excluding Anti-VEGF
- Date/Time: April 29, 2018 from
8:15am – 10:00am
Vision Restoration Paper Presentation
- Title: Transplantation of
laboratory-grown human retinal tissue in the subretinal space of
the cat eye
- Presentation Number: 2986
- Session Title: Retinal Gene
Therapy and Stem Cell Transplantation
- Date/Time: May 1, 2018 from
12:15pm – 12:30pm
As a reminder, BioTime's Vision Restoration program is based on
the ability to generate 3-dimensional human retinal tissue derived
from human pluripotent cells. The Company's 3-dimensional retinal
tissue technology may address the unmet need of implementing a
retinal restoration strategy to address severe retinal degenerative
diseases. In 2017, the Small Business Innovation
Research program of the National Institutes of Health
awarded BioTime a grant of up to $1.56 million to further develop
this innovative, next generation vision restoration program.
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 in 2017. Submission for approval of Renevia® in the
EU is expected to be early 2018, with possible approval in 2018.
There were no device related serious adverse events reported to
date. 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 to date. BioTime also has significant equity
holdings in two publicly traded companies, Asterias
Biotherapeutics, Inc. (NYSE American: AST) and OncoCyte
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/20180215005399/en/
Investor Contact:BioTimeDavid Nakasone,
510-871-4188Dnakasone@biotime.comorMedia Contact:JQA
Partners, Inc.Jules Abraham,
917-885-7378jabraham@jqapartners.com
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