BioTime, Inc. (NYSE MKT: BTX) announced today the issuance of 14
new patents covering a wide range of the core technologies of
BioTime and its subsidiaries Asterias Biotherapeutics, Inc. (NYSE
MKT: AST), OrthoCyte Corporation, ES Cell International Pte Ltd,
OncoCyte Corporation, and ReCyte Therapeutics, Inc. The new patents
issued over Q3 and Q4 of 2014 add to the BioTime family of
companies’ patent estate of over 600 patents and patent
applications pending worldwide, which is the largest known patent
estate in the field of pluripotent stem cell technology for human
therapeutic application, an emerging field known as “regenerative
medicine.”
Pluripotent stem cells are cells capable of indefinite expansion
and then differentiation into any and all of the cell types of the
human body. Examples of pluripotent stem cells are human embryonic
stem cells (“hES”) and induced pluripotent stem (“iPS”) cells.
These stem cells potentially offer a new technology platform for
the manufacture of a wide array of cell types designed to be
transplanted into the body to restore healthy tissue function.
“BioTime and its subsidiaries are focused on developing and
commercializing a broad portfolio of innovative cellular
therapeutics and diagnostic products, while also continuing to
build value in other ways, such as through the addition of new
patents to our industry-leading intellectual property estate,” said
Dr. Michael D. West, Ph.D., BioTime’s Chief Executive Officer. “We
are making significant strides in patenting our core platform of
pluripotent stem cell technology and strengthening our competitive
position in regenerative medicine. For the first time in history,
pluripotent stem cells offer a means of manufacturing previously
rare and valuable human cell types in a cost-effective manner and
on an industrial scale. We plan to utilize our strengthened patent
position to drive value for our shareholders as the field of
regenerative medicine begins to address the large and growing
markets associated with chronic and age-related degenerative
disease.”
New Patents Owned by BioTime or one of its
subsidiaries:
European patent 1809739 – This issued patent claims cell
culture media for the proliferation and scale-up of hES cells. The
patent issuing in Austria, France, Germany, Ireland, Switzerland
and Sweden provides a propagation medium for culturing hES cells in
the laboratory such that the cells proliferate without
differentiating as defined in the claims. The technology allows the
user to rapidly produce high-quality embryonic stem cells for use
in therapy and drug discovery, in a cost-effective and controlled
manner, from defined or commercially available reagents. The patent
is therefore useful for manufacturing products from hES cells.
Patents in the same family have previously issued in the United
States, Australia, UK, Israel, Singapore and Hong Kong, with
additional applications pending.
Canada patent 2559854 and China patent ZL200580008779.0 –
These patents claim a differentiation method for making high purity
heart muscle preparations from pluripotent stem cells such as hES
cells suitable for use in regenerative medicine. The issued claims
cover methods wherein the pluripotent stem cells are treated with
specific growth factors and differentiation conditions to
manufacture beating heart muscle cells. The patents are therefore
useful in the manufacture and commercialization of heart muscle
cells for research, for the testing of drugs on the heart, and
potentially for regenerating heart muscle following a heart attack
or heart failure. Patents in the same family have previously issued
in the United States, Australia, UK, Israel, Japan and Singapore,
with additional applications pending.
South Korea patent 1543500B – The patent
titled, “Hematopoietic Cells from Human Embryonic Stem Cells,”
claims methods for using pluripotent stem cell technology for
inducing immune tolerance of cells transplanted into a patient
(that is, in helping to prevent the rejection of transplanted
cells). As such, the patent claims may be useful in commercializing
diverse types of transplantable cells. Patents in the same family
have previously issued in Australia, UK, Israel, Japan and
Singapore, with additional applications pending.
Canada patent 2468335 – The patent describes
cartilage-forming cells derived from human pluripotent stem cells
such as hES cells. The claims in the patent relate to a system of
making the cartilage-forming cells using factors of the
transforming growth factor beta (TGF-beta) family, of immortalizing
the cells with the human telomerase gene, pharmaceutical
formulations of the cells for therapeutic use in arthritis, as well
as other claims. The patent is therefore useful for the manufacture
of such cells for use in research and potentially in therapy for a
number of applications in orthopedic medicine. Patents in the same
family have previously issued in the United States, Australia,
Singapore, Israel and South Korea, with additional applications
pending.
Israel patent 208116 – The patent titled,
“Differentiation of Primate Pluripotent Stem Cells to Hematopoietic
Lineage Cells,” claims methods for the manufacture of dendritic
cells from primate pluripotent stem cells. Dendritic cells are
cells that trigger an immune response to a particular molecule.
Often their role is to stimulate the immune system to attack
microorganisms such as bacteria. BioTime’s subsidiary Asterias
Biotherapeutics is developing hES cell-derived dendritic cells
modified to trigger an immune response to specific antigens related
to cancer. A patent in the same family has previously issued in the
United States, with additional applications pending.
Singapore patent 188098 – The patent titled, “Synthetic
Surfaces for Culturing Stem Cell Derived Cardiomyocytes,” claims
certain polymers upon which heart muscle cells derived from
pluripotent stem cells may be cultured. The patent is potentially
useful for the manufacture of human heart muscle cells for drug
screening and toxicity testing and for use in the manufacture of
such cells for transplantation into human subjects for the
treatment of heart disease. A patent in the same family has
previously issued in the United States, with additional
applications pending.
Singapore patent 176957 – The patent titled,
“Differentiated Pluripotent Stem Cell Progeny Depleted of
Extraneous Phenotypes,” claims methods for the purification of
pluripotent stem cell-derived oligodendrocytes by the removal of
contaminating cells that display an antigen called epithelial cell
adhesion molecule (EpCAM). This method is potentially useful in the
purification of such oligodendrocytes prior to their use in
research or human therapy. Patents in the same family have
previously issued in the United States and China, with additional
applications pending.
Singapore patent 177694 – The patent titled, “Methods and
Compositions for in vitro and in vivo Chondrogenesis,” claims
methods for the manufacture of cartilage from BioTime’s PureStem®
cell lines 4D20.8, SM30, E15, MEL2, SK11, and 7SMOO32, methods for
combining the cells with matrices, and molding the cartilage to
produced formed tissue. The patent is potentially useful for
BioTime’s subsidiary OrthoCyte Corporation in the manufacture of
human cartilage grafts for the repair of orthopedic disorders such
as arthritis and degeneration of the intervertebral disc. A patent
in the same family has previously issued in the United States, with
additional applications pending.
Australia patent 2011258249 – The patent titled,
“Improved Methods of Screening Embryonic Progenitor Cell Lines,”
claims compositions and methods relating to BioTime’s PureStem®
cell lines expressing the gene EYA4 which are capable of
differentiating into skin fat cells, including brown fat cells that
have the potential to be useful to BioTime’s subsidiary ReCyte
Therapeutics and may have uses in the treatment of metabolic
disorders such as obesity and Type II diabetes. Claims were also
issued relating to the manufacture of kits including the components
described in the patent which may be useful in the development of
new research products for sale through BioTime’s ESI BIO Division.
Patents in the same family are currently pending in other
jurisdictions.
Australia patent 200735127 – This patent claims methods
for identifying and selecting heart muscle cells made from
pluripotent stem cells. In particular, the patent identifies
molecules associated with cells that can be used to sort heart
muscle from other cell types and thereby generate purified product.
Methods are claimed for use of the cells in drug testing as well as
for the transplantation of such cells into human subjects for the
treatment of heart disease. A patent in the same family has
previously issued in the United Kingdom, with additional
applications pending.
Israel patent 179785 – This patent claims methods
relating to the freezing of pluripotent stem cells such as human
embryonic stem cells that are capable of becoming liver cells,
heart muscle cells, pancreatic cells, cartilage cells, as well as
other cell types and is therefore potentially useful for the
manufacture and storage of cells for research and therapy. Patents
in the same family have previously issued in Australia, UK and
Singapore, with additional applications pending.
In-licensed Patents:
United States patent 8921104 – The patent titled,
“Method for Producing Dendritic Cells,” claims methods relating to
embryonic stem cell-derived dendritic cells. Dendritic cells are
cells that present molecules to the immune system in order to
trigger an immune response to that particular protein. BioTime’s
subsidiary Asterias Biotherapeutics is developing hES cell-derived
dendritic cells modified to trigger an immune response to certain
antigens related to cancer. Patents in the same family have
previously issued in the United States (3 others issued), China and
Australia, with additional applications pending in multiple
jurisdictions.
United States patent 8,815804 – Claims in this case
relate to peptides that selectively home to tumors, blood clots
and/or other injury sites in a subject and are potentially useful
in targeting cells to cancer as a novel therapeutic strategy. The
patent is licensed to BioTime’s subsidiary OncoCyte Corporation. A
European patent has previously issued in this family, with national
patents granted in Finland, France, Germany, Ireland, Lithuania,
Luxenbourg, Monaco, Netherlands, Sweden, Switzerland and the UK.
Additional applications pending in multiple jurisdictions.
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
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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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