- New issued patents add to existing estate of
over 600 patents and patent applications worldwide in the emerging
field of pluripotent stem cell technology -
BioTime, Inc. (NYSE MKT:BTX) announced today the issuance of 14
new patents to BioTime and its subsidiary companies. The patents
issued in Australia, Canada, China, Japan, and the United States,
cover a wide range of core technologies foundational to BioTime’s
businesses. The new patents add to the largest known patent estate
under one corporate umbrella in the field of pluripotent stem cell
technology known as “regenerative medicine” with over 600 existing
patents and patent applications owned or licensed to BioTime and
its subsidiaries worldwide.
“As a biotechnology company, our intellectual property portfolio
is an important asset that supports our product development
programs and drives value in our business transactions,” said Dr.
Michael D. West, Ph.D., BioTime’s Chief Executive Officer. “The new
patents are expected to contribute to shareholder value for BioTime
generally, for our corporate partners, and for our individual
subsidiary businesses that are focused on applying our platform
technologies to specific medical applications. These patents also
provide BioTime with new opportunities to partner critical stem
cell technologies with companies developing and commercializing
advanced technologies in the regenerative medicine field.”
Background
BioTime is a leader in the emerging field of regenerative
medicine whose foundation is based on pluripotent stem cell
technology. Its current leadership position is in part based on the
early nature of the research performed by its inventors. Scientists
at BioTime, and its subsidiary Asterias Biotherapeutics, Inc.
previously led the world in isolation of the first human
pluripotent stem cells known as human embryonic stem cells. These
first-in-class intellectual property assets originally built at
Geron Corporation are now being developed within Asterias. Being
the first company in the world to have access to these cells, our
scientists and our collaborators were able to file numerous broad
foundational patents in the field such as US patent number
8,637,311 described herein which claims human embryonic stem cells
cultured on a matrix free of feeder cells wherein the stem cells
are genetically modified.
In competition with Geron, the Singapore-based company ES Cell
International and Cell Cure Neurosciences Ltd also built key assets
and were later acquired as subsidiaries of BioTime. In addition,
after leaving Geron in 1998, Dr. West led the competing company
Advanced Cell Technology from 1998-2005 and after coming to BioTime
he licensed certain other key patent applications from ACT. These
included compositions and methods for deriving more than 200
purified lineages of cells, a technology known as “PureStem®” (US
Patent number 8,685,386) as well as US Patent number 8,753,884
which describes an important and broad pathway of making all human
cell types without ever creating or using human embryonic or
induced pluripotent stem cells.
Pluripotent stem cells are capable for the first time in the
history of medicine of becoming all the cell types of the human
body. The unlimited replicative capacity of pluripotent stem cells
also allows for the first time, the production of master cell banks
of the stem cells from which any human cell type can be
manufactured in limitless quantities. This power to make the
hundreds of cell types that comprise the human body combine with
the massive scalability of the manufacturing platform, together
leads to the interest the scientific and pharmaceutical communities
have in using the technology to manufacture cells, instead of
drugs, that can be used to regenerate tissues impaired by injury or
degenerative disease. The rapid rise in age-related degenerative
diseases such as age-related macular degeneration, arthritis,
coronary disease, Parkinson’s, and stroke, to name a few, make
regenerative medicine one of the most anticipated new technologies
for the future of health care.
New Patents Owned by BioTime or one of its
subsidiaries:
United States patent 8,685,386 – This patent is
based on work performed at BioTime on the PureStem® cell lines
capable of becoming cell types useful in the repair of cartilage
and bone. The claims cover certain PureStem® cell types as well as
certain products made from them used in patients. Titled “Methods
and Compositions for In Vitro and In Vivo Chondrogenesis,” this
patent is one of numerous patents useful to BioTime’s subsidiary
OrthoCyte Corporation.
United States patent 8,728,457 – Methods of inducing the
differentiation of embryonic stem cells into mesodermal cells
(one of the three major branches of cell types in the human body
that includes heart muscle and blood vessel cells) by contacting
the stem cells with certain cells from one of the other major
branches of cells (such as the endoderm or ectoderm). The patent
relates to methods of making cardiomyocytes and vascular
endothelial cells and is therefore useful for BioTime’s subsidiary
ReCyte Therapeutics, Inc.
United States patent 8,637,311 – The claims in this
patent related to human embryonic stem cells that are cultured on
extracellular matrix free of feeder cells and that are genetically
modified.
Australia patent 2012203810 – Methods and Compositions
for the Treatment and Diagnosis of Bladder Cancer. The patent
relates to methods of detecting bladder cancer by contacting a
sample from a subject with agents that bind certain proprietary
markers expressed in patients with bladder cancer. The patent is
useful for BioTime’s subsidiary OncoCyte Corporation for its cancer
diagnostic product development.
Australia patent 2010200610 – The claims in this patent
relate to cell cultures comprising endoderm cells, one of the three
major lineages of cells that make up the human body. In particular,
endoderm cells make cells of internal organs such as the lung,
pancreas, and liver as well as other internal cell types.
Canada patent 2,459,957 – This patent contains
claims related to the feeder-free culture of pluripotent stem cells
wherein the stem cells are grown on an extracellular matrix and
stimulated to grow with a fibroblast growth factor. In addition,
the patent contains additional claims such as to
genetically-modified pluripotent stem cells grown on such
feeder-free conditions.
China patent 1543500B – The claims of this patent
relate to heart muscle cells (cardiomyocytes) produced under
certain conditions from human embryonic stem cells in
conditions essentially free of feeder cells.
China patent 102803472B – The claims in this patent
relate to methods to purify cellular formulations made from
pluripotent stem cell progeny wherein the cell population comprises
oligodendrocytes.
Japan patent 5479661 – Methods of Inducing
Differentiation of Stem Cells. The patent relates to methods of
making cardiomyocytes and vascular endothelial cells.
Japan patent 5460677 – is a patent with claims
related to endoderm cells. Endoderm is one of the three major
branches of cells originating from pluripotent stem cells.
Endodermal cells contribute to internal organs such as the
esophagus, stomach, lungs, liver, pancreas, as well as other
tissues. The issued claims relate to such cells produced from human
embryonic stem cells cultured in the presence of a growth factor
known as activin.
Japan patent 2011-047716 – Oligodendrocytes derived from
human embryonic stem cells for remyelination and treatment of
spinal cord injury are described. The patent relates to
methods of making oligodendrocytes from human embryonic stem cells.
The patent is useful to Asterias Biotherapeutics, Inc. for its
AST-OPC1 product development.
In-licensed Patents:
United States patent 8,691,793 – Certain claims in this
patent relate to chemical modifications of glycosaminoglycans such
as hyaluronic acid (one of the components of at least two
HyStem®-related products in development by BioTime).
United States patent 8,753,884 – This patent has broad
claims related to methods of producing human differentiated cells
of any type from the morula or inner cell mass of an embryo without
making human embryonic stem cell lines or induced pluripotent stem
cell lines.
United States patent 8,637,635 – Claims in this
case related to peptides that selectively home to heart vasculature
and related conjugates and methods.
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. BioTime is developing Renevia™ (a
HyStem® product) as a biocompatible, implantable hyaluronan and
collagen-based matrix for cell delivery in human clinical
applications, and is planning to initiate a pivotal clinical trial
around Renevia™, in 2014. 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.
- 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,
including the development of retinal pigment epithelial cells for
the treatment of macular degeneration, and treatments for multiple
sclerosis.
- 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 three clinical trials 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 stock is traded on the NYSE MKT, ticker 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 businesses of BioTime
and its subsidiaries, including Asterias Biotherapeutics, Inc.,
particularly those mentioned in the cautionary statements found in
BioTime's and Asterias’ 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.com
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