BioTime Reports Isolation of Seven Diverse Cartilage and Bone Cell Types From Human Embryonic Stem Cells ALAMEDA, Calif.--(BUSINESS WIRE)--Dec. 18, 2012--
BioTime, Inc. (NYSE MKT: BTX), a biotechnology company that develops and
markets products in the field of regenerative medicine, and its
subsidiaries OrthoCyte Corporation and LifeMap Sciences reported today a
means of manufacturing seven distinct types of cartilage, bone, and
tendon cells from human embryonic stem cells. The paper, scheduled to be published
online (ahead of print) at 1600 GMT today in the peer-reviewed
journal Regenerative
Medicine, characterizes the seven cell types generated using
BioTime’s proprietary PureStemTM technology. The study
compared the novel cells with adult stem cells, known as mesenchymal
stem cells (MSCs), and revealed properties of the new cell lines that
are suggestive of a wide array of future applications in the practice of
orthopedic medicine.
In the study published today, it was demonstrated that BioTime’s cells,
which can be manufactured on an industrial scale, are progenitors to
diverse skeletal tissues of the human body. These cell lines bear
diverse molecular markers that distinguish them from each other and from
MSCs. The molecular markers of BioTime’s cell lines suggest the lines
may therefore be applicable to the repair of different types of bone,
cartilage, and tendon for the treatment of degenerative diseases
afflicting these tissue types such as non-healing bone fractures,
osteoarthritis and degeneration of intervertebral discs, and tendon
tears (tendinosis).
Chronic orthopedic disorders such as osteoarthritis, degeneration of the
discs in the spine, osteoporosis, and tendon tears are among the leading
complaints and causes of disability in an aging society. The recent
isolation of new pluripotent stem cells such as human embryonic stem
(hES) cells and induced pluripotent stem (iPS) cells opens the door to
the manufacture of all of the cell types in the human body on an
industrial scale. These achievements in the emerging field of
regenerative medicine have made it feasible to introduce new modalities
of repairing these and other tissues in the body.
As promising as these new stem cells may be for eventual human tissue
repair, there has been little progress to date in identifying new ways
to generate pure populations of the diverse cellular components of the
human body using methods that are also compatible with industrial-scale
manufacture. To address this need, BioTime scientists developed a novel
and proprietary manufacturing process. These isolated PureStemTM
(previously ACTCellerateTM) cell lines allow
for the scale-up of more than 200 highly purified and identified cell
types.
In today's publication, BioTime scientists reported on seven PureStemTM
cell lines representing diverse cells of the developing human skeleton.
One of these cell lines, 4D20.8, was previously shown by BioTime
scientists to exhibit site-specific markers of craniofacial mesenchyme,
and in particular, markers of proximal mandibular mesenchyme. This
tissue type is of significance in that it naturally produces one of the
strongest joint cartilages of the body. In today’s report, this line was
compared to the BioTime’s lines 7PEND24, 7SMOO32, E15, MEL2, SK11, SM30,
and to other commonly studied MSCs. BioTime’s cell lines displayed
markers that indicated the cells were progenitors of diverse cartilage,
bone, and tendon cell types in the body.
There remains the need for safe methods of manufacturing cells at a high
degree of purity and site-specific identity, in addition to an
FDA-approvable combination with a matrix to facilitate the stable
transplantation of those cells into the body. BioTime’s HyStem®
technology is designed to be an effective means of transplanting
cells in an injectable liquid that can polymerize safely in the body
into a tissue construct. BioTime anticipates that during the first
quarter of 2013, a submission of a Phase I safety trial in humans will
be made to the appropriate European Committee for review and approval of HyStem®
formulated for the delivery of autologous fat-derived cells for skin
applications, a product called Renevia™. In today’s publication,
the seven novel osteochondral cell lines were demonstrated to be
successfully differentiated in HyStem® in
laboratory experiments, supporting the potential use of the product
together with these and other PureStemTM cell lines in
combination products.
The study’s demonstration of the manufacture of diverse site-specific
tissue progenitors from pluripotent stem cells serves to highlight the
utility of LifeMap Discovery™, a powerful new database that
provides a roadmap to the complex fabric of cells constituting the human
body. In today’s publication, BioTime and LifeMap scientists
collaborated to map the molecular markers of the published PureStemTM
cell lines within the database, thus making the lines available
for the research community in the context of the human developmental
tree.
“We are gratified to finally report in a scientific publication the
power of monoclonal human embryonic progenitor cell lines to scale
diverse cell types of the human body,” said Michael D. West, Ph.D.,
BioTime's Chief Executive Officer. “Our confidence that many other cell
types of the human body can be manufactured in this manner is the reason
for our focus on this platform and for participating in building LifeMap
DiscoveryTM to help the medical research community
navigate this fascinating yet complex network of product development.”
Arnold Caplan, Ph.D., OrthoCyte's Chief Scientific Officer and Director
of the Skeletal Research Center at Case Western Reserve University,
commented that the paper by Sternberg and colleagues “emphasizes the
scalability of clonal human embryonic stem cell-derived cell lines for
musculoskeletal tissue engineering. The analysis at the molecular level
of the biological markers gives us confidence that these groups of cells
can be used for cartilage repair and regeneration. The amount of cells
that can be generated is really practical for human
musculoskeletal tissue regeneration.”
A discussion of OrthoCyte's product development strategy delivered by
Dr. Caplan and comments on the implications of BioTime's scientific
advances are available online at www.biotimeinc.com
and www.orthocyte.com.
Authors of today’s publication include Hal Sternberg, Jennifer Kidd,
James T. Murai, Jianjie Jiang, Isaac E. Erickson, Walter D. Funk, Karen
B. Chapman, and Michael D. West of BioTime and OrthoCyte Corporation;
Ariel Rinon of LifeMap Sciences; and C. Thomas Vangsness, Jr., of the
Keck School of Medicine at the University of Southern California.
About BioTime, Inc.
BioTime, headquartered in Alameda, Calif., is a biotechnology company
focused on regenerative medicine and blood plasma volume expanders. Its
broad platform of stem cell technologies is enhanced through
subsidiaries focused on specific fields of application. BioTime develops
and markets research products in the fields of stem cells and
regenerative medicine, including a wide array of proprietary PureStem™
cell lines, HyStem® hydrogels, culture media, and
differentiation kits. BioTime is developing Renevia™ (formerly
known as HyStem®-Rx), a biocompatible,
implantable hyaluronan and collagen-based matrix for cell delivery in
human clinical applications. BioTime's therapeutic product development
strategy is pursued through subsidiaries that focus on specific organ
systems and related diseases for which there is a high unmet medical
need. BioTime's majority owned subsidiary Cell Cure Neurosciences Ltd.
is developing therapeutic products derived from stem cells for the
treatment of retinal and neural degenerative diseases. BioTime's
subsidiary OrthoCyte Corporation is developing therapeutic applications
of stem cells to treat orthopedic diseases and injuries. Another
subsidiary, OncoCyte Corporation, focuses on the diagnostic and
therapeutic applications of stem cell technology in cancer, including
the diagnostic product PanC-Dx™ currently being developed for the
detection of cancer in blood samples. ReCyte Therapeutics, Inc. is
developing applications of BioTime's proprietary induced pluripotent
stem cell technology to reverse the developmental aging of human cells
to treat cardiovascular and blood cell diseases. BioTime's subsidiary
LifeMap Sciences, Inc., markets GeneCards®, the
leading human gene database, and has developed an integrated database
suite to complement GeneCards® that includes the LifeMap
Discovery™ database of embryonic development, stem cell research and
regenerative medicine, and MalaCards, the human disease database.
LifeMap is also marketing BioTime research products. BioTime's lead
product, Hextend®, is a blood plasma volume expander
manufactured and distributed in the U.S. by Hospira, Inc., and in South
Korea by CJ CheilJedang Corporation under exclusive licensing
agreements. Additional information about BioTime can be found on the web
at www.biotimeinc.com.
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.
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Source: BioTime, Inc.
BioTime, Inc.
Peter Garcia, 510-521-3390, ext 367
Chief
Financial Officer
pgarcia@biotimemail.com
or
Judith
Segall, 510-521-3390, ext 301
jsegall@biotimemail.com
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