BioTime, Inc. (NYSE MKT: BTX) and its subsidiary Cell Cure
Neurosciences Ltd. (“Cell Cure”) today provided an update on Cell
Cure’s product development and partnering activities.
On February 16, 2015, Cell Cure opened the clinical trial of
OpRegen® titled “Phase I/IIa Dose Escalation Safety and Efficacy
Study of Human Embryonic Stem Cell-Derived Retinal Pigment
Epithelium Cells Transplanted Subretinally in Patients with
Advanced Dry-Form Age-Related Macular Degeneration with Geographic
Atrophy” at Hadassah University Medical Center in Jerusalem,
Israel. Patient enrollment is expected to begin shortly. OpRegen
consists of animal product-free retinal pigment epithelial (RPE)
cells with high purity and potency.
On October 31, 2014, the United States Food and Drug
Administration (FDA) cleared Cell Cure's Investigational New Drug
(IND) application to initiate the clinical trial of OpRegen in
patients with the severe form of age-related macular degeneration
(AMD) with geographic atrophy (GA). While treatment options exist
for the treatment of the wet form of AMD, it amounts to only about
10% of the disease prevalence. There is currently no FDA-approved
therapy for the dry form occurring in approximately 90% of those
afflicted with AMD. Cell Cure intends to transplant OpRegen as a
single dose into the subretinal space of patients’ eyes in order to
test the safety and efficacy of the product in this leading cause
of blindness.
The Phase I/IIa clinical trial, will evaluate three different
dose regimens of OpRegen. Following transplantation, the patients
will be followed for 12 months at specified intervals, to evaluate
the safety and tolerability of the product. Following the initial
12 month period, patients will continue to be monitored at longer
intervals for an additional period of time. A secondary objective
of the clinical trial will be to examine the ability of
transplanted OpRegen to engraft, survive, and moderate disease
progression in the patients. In addition to thorough
characterization of visual function, a battery of ophthalmic
imaging modalities will be used to quantify structural changes and
rate of GA expansion.
Cell Cure also announced today that the option granted to Teva
Pharmaceutical Industries Ltd. (“Teva”) under a Research and
Exclusive Option Agreement of October 7, 2010 to license-in rights
to its OpRegen product has expired without having been exercised by
Teva. Cell Cure will therefore be continuing the clinical
development of OpRegen on its own and pursuing discussions with
other potential strategic partners, including those that have
already indicated interest in participating in development and
commercialization of the product.
Cell Cure also announced that US patent No. 8,956,866 relating
to a proprietary method of manufacturing RPE cells (the active
ingredient of OpRegen) is expected to issue on February 17, 2015.
This patent combined with other patents and patent applications in
the BioTime family of companies provides significant patent
protection for this novel therapeutic modality for AMD.
“The large markets currently associated with therapies for the
wet form of AMD combined with the elegance of RPE replacement
therapy for the larger unmet needs associated with the dry form,
highlights why Cell Cure has prioritized the development of this
product,” said Dr. Charles Irving, CEO of Cell Cure. “We look
forward to initiation of the trials and providing updates in the
coming months.”
About Age-Related Macular Degeneration
Age-related macular degeneration (AMD) is one of the major
diseases of aging and is the leading eye disease responsible for
visual impairment of older persons in the US, Europe and Australia.
AMD affects the macula, which is the part of the retina responsible
for sharp, central vision that is important for facial recognition,
reading and driving. There are two forms of AMD. The dry form
(dry-AMD) advances slowly and painlessly but may progress to
geographic atrophy (GA) in which RPE cells and photoreceptors
degenerate and are lost. Once the atrophy involves the fovea (the
center of the macula), patients lose their central vision and may
develop legal blindness. There are about 1.6 million new cases of
dry-AMD in the US annually, and as yet there is no effective
treatment for this condition. About 10% of patients with dry-AMD
develop wet (or neovascular) AMD, the second main form of this
disease, which usually manifests acutely and can lead to severe
visual loss in a matter of weeks. Wet-AMD can be treated with
currently-marketed VEGF inhibitors. However, such products
typically require frequent repeated injections in the eye, and
patients often continue to suffer from continued progression of the
underlying dry-AMD disease process. Current estimated annual sales
of VEGF inhibitors for the treatment of the wet form of AMD are
estimated to be in excess of $5 billion worldwide. The root cause
of the larger problem of dry-AMD is believed to be the dysfunction
of RPE cells. One of the most exciting therapeutic approaches to
dry-AMD is the transplantation of healthy, young RPE cells to
support and replace the patient’s old degenerating RPE cells, which
may prevent progression of the atrophy as well as the development
of wet-AMD. Pluripotent stem cells, such as hESCs, can provide an
unlimited source for the derivation of such healthy RPE cells for
transplantation.
About OpRegen®
Cell Cure's OpRegen® consists of RPE cells that are produced
using a proprietary process that drives the differentiation of
human embryonic stem cells into high purity RPE cells. OpRegen is
also “xeno-free," meaning that no animal products were used either
in the derivation and expansion of the human embryonic stem cells
or in the directed differentiation process. The avoidance of the
use of animal products eliminates some safety concerns. OpRegen is
formulated as a suspension of RPE cells. Preclinical studies in
mice have shown that following a single subretinal injection of
OpRegen, the cells can rapidly organize into their natural
monolayer structure and survive throughout the lifetime of the
animal. OpRegen is designed to be an “off-the-shelf” allogeneic
product provided to retinal surgeons in a final formulation ready
for transplantation. Unlike treatments that require multiple,
frequent injections into the eye, such as currently-marketed
products like Lucentis and Eylea for wet-AMD, it is expected that
OpRegen would be administered in a single procedure.
About Cell Cure Neurosciences Ltd.
Established in 2005, Cell Cure is located in Jerusalem, Israel
on the campus of Hadassah Medical Center. Cell Cure's mission is to
become a leading supplier of human cell-based therapies for the
treatment of retinal and neural degenerative diseases. Its
technology platform is based on the manufacture of diverse cell
products sourced from clinical-grade (GMP-compatible) human
embryonic stem cells. Its current focus is the development of
retinal pigment epithelial (RPE) cells for the treatment of
age-related macular degeneration. Cell Cure's major shareholders
include BioTime, Inc. (NYSE MKT: BTX), HBL Hadasit Bio-Holdings
Ltd., Teva Pharmaceuticals Industries Ltd., and Asterias
Biotherapeutics,Inc. Additional information about Cell Cure can be
found on the web at www.cellcureneurosciences.com.
About BioTime
BioTime is a biotechnology company engaged in research and
product development in the field of regenerative medicine.
Regenerative medicine refers to therapies based on stem cell
technology that are designed to rebuild cell and tissue function
lost due to degenerative disease or injury. BioTime’s focus is on
pluripotent stem cell technology based on human embryonic stem
(“hES”) cells and induced pluripotent stem (“iPS”) cells. hES and
iPS cells provide a means of manufacturing every cell type in the
human body and therefore show considerable promise for the
development of a number of new therapeutic products. BioTime’s
therapeutic and research products include a wide array of
proprietary PureStem® progenitors, HyStem® hydrogels, culture
media, and differentiation kits. Renevia™ (a HyStem product), is
now in a pivotal trial in Europe as a biocompatible, implantable
hyaluronan and collagen-based matrix for cell delivery in the
treatment of HIV-related lipoatrophy. In addition, BioTime has
developed Hextend®, a blood plasma volume expander for use in
surgery, emergency trauma treatment and other applications. Hextend
is manufactured and distributed in the U.S. by Hospira, Inc. and in
South Korea by CJ HealthCare Corporation, under exclusive licensing
agreements.
BioTime is also developing stem cell and other products for
research, therapeutic, and diagnostic use through its
subsidiaries:
- Asterias Biotherapeutics, Inc. is
developing pluripotent stem-cell based therapies in neurology and
oncology, including AST-OPC1 oligodendrocyte progenitor cells in
spinal cord injury, multiple sclerosis and stroke, and AST-VAC2, an
allogeneic dendritic cell-based cancer vaccine. Asterias Series A
common stock is traded on the NYSE MKT under the symbol AST.
- BioTime Asia, Ltd., a Hong Kong
company, may offer and sell products for research use for BioTime’s
ESI BIO Division.
- Cell Cure Neurosciences Ltd. is an
Israel-based biotechnology company focused on developing stem
cell-based therapies for retinal and neurological disorders.
OpRegen® is currently in a Phase I/IIa clinical trial for the
treatment of the dry-form of age-related macular degeneration.
- ESI BIO is the research and product
marketing division of BioTime, providing stem cell researchers with
products and technologies to enable them to translate their work
into the clinic, including PureStem® progenitors and HyStem®
hydrogels.
- LifeMap Sciences, Inc. markets, sells,
and distributes GeneCards®, the leading human gene database, as
part of an integrated database suite that also includes the LifeMap
Discovery® database of embryonic development, stem cell research,
and regenerative medicine, and MalaCards, the human disease
database.
- LifeMap Solutions, Inc. is a subsidiary
of LifeMap Sciences focused on developing mobile health (mHealth)
products.
- OncoCyte Corporation is developing
products and technologies to diagnose and treat cancer, including
PanC-Dx™, with four clinical studies currently underway.
- OrthoCyte Corporation is developing
therapies to treat orthopedic disorders, diseases and
injuries.
- ReCyte Therapeutics, Inc. is developing
therapies to treat a variety of cardiovascular and related ischemic
disorders, as well as products for research using cell
reprogramming technology.
BioTime common stock is traded on the NYSE MKT under the symbol
BTX. For more information, please visit www.biotimeinc.com or
connect with the company on Twitter, LinkedIn, Facebook, YouTube,
and Google+.
Forward-Looking Statements
Statements pertaining to future financial and/or operating
results, future growth in research, technology, clinical
development, and potential opportunities for BioTime and its
subsidiaries, along with other statements about the future
expectations, beliefs, goals, plans, or prospects expressed by
management constitute forward-looking statements. Any statements
that are not historical fact (including, but not limited to
statements that contain words such as “will,” “believes,” “plans,”
“anticipates,” “expects,” “estimates”) should also be considered to
be forward-looking statements. Forward-looking statements involve
risks and uncertainties, including, without limitation, risks
inherent in the development and/or commercialization of potential
products, uncertainty in the results of clinical trials or
regulatory approvals, need and ability to obtain future capital,
and maintenance of intellectual property rights. Actual results may
differ materially from the results anticipated in these
forward-looking statements and as such should be evaluated together
with the many uncertainties that affect the business of BioTime and
its subsidiaries, particularly those mentioned in the cautionary
statements found in BioTime's Securities and Exchange Commission
filings. BioTime disclaims any intent or obligation to update these
forward-looking statements.
To receive ongoing BioTime corporate communications, please
click on the following link to join our email alert list:
http://news.biotimeinc.com
BioTime, Inc.Judith Segall, 510-521-3390 ext.
301jsegall@biotimemail.comorInvestor Contact:EVC Group, Inc.Gregory
Gin, 862-236-0673ggin@evcgroup.comJames Dawson,
646-445-4800jdawson@evcgroup.comDoug Sherk,
415-652-9100dsherk@evcgroup.com
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