There were no treatment-related serious adverse events after 15 months
Signs of engraftment and cell survival have been maintained
ALAMEDA, Calif.--(BUSINESS WIRE)--Nov. 15, 2017--
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.
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,
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,
To receive ongoing BioTime corporate communications, please click on the
following link to join the Company’s email alert list: http://news.biotime.com.
View source version on businesswire.com: http://www.businesswire.com/news/home/20171115005559/en/
Source: BioTime, Inc.
David Nakasone, 510-871-4188
JQA Partners, Inc.
Jules Abraham, 917-885-7378