BioTime, Inc. (NYSE Amex: BTX) announced today the issuance of United
States patent number 7,981,871 titled "Modified Macromolecules and
Associated Methods of Synthesis and Use,” covering aspects of the
composition of Glycosan hydrogels. The patent and related patent family
members, assigned to the University of Utah, are licensed to BioTime’s
subsidiary OrthoCyte Corporation for the manufacture of research
products and for therapeutic uses when combined with human cells by
Biotime or its subsidiaries. The patent is of strategic value to the
BioTime family of companies, as it provides protection for the
formulation of a number of adult and embryonic stem cell-based cellular
therapies that may be developed using Glycosan hydrogels, as well as for
a stand-alone medical device, HyStem®-Rx, that is
currently under development by BioTime.
The new patent protects compositions related to the products HyStem and
Extracel, both of which are cross-linked scaffolds of two molecules
crucial to connective tissues, collagen and hyaluronic acid. Together
with the previously issued United States patent 7,928,069, which
protects the composition of certain chemical modifications of the
extracellular matrix proteins and gelatin, this patent covers the
complete composition of HyStem®-Rx products. The
allowed claims include 3-D cell culture, as well as pharmaceutical
compositions that combine the products with human cells of all types.
"This patent represents the second U.S. patent issued that covers
Glycosan hydrogels, and its claims cover, among other things, HyStem®-Rx,
a product slated for near-term development as a medical device for the
delivery of cells,” said Michael D. West, Ph.D., President and Chief
Executive Officer of BioTime. "Our subsidiary OrthoCyte Corporation is
already utilizing HyStem® hydrogels in the development
of stem cell-based products for the treatment of osteoarthritis.”
HyStem®-Rx is a biocompatible hydrogel that mimics the
extracellular matrix in which cells reside. As an injectable product,
HyStem®-Rx may address an immediate need in cosmetic
and reconstructive surgery and other procedures by improving the process
of transplanting adipose (fat) cells or other adult stem cells. Adult
stem cell types such as adipose stem cells obtained from a patient
through liposuction can be transplanted back into the same patient at
another location in the body, without the risk of rejection associated
with the transplant of donor tissues. However, the transplantation of
cells without the molecular matrix in which cells normally reside often
leads to widespread cell death or the failure of the transplanted cells
to remain at the transplant site. The transfer of cells in HyStem®-Rx
may resolve these issues by localizing the transplanted cells at the
intended location and by providing a three-dimensional form upon which
cells can rebuild normal tissue. HyStem®-Rx may
support other emerging cell and tissue transplant therapies such as
those derived from human embryonic stem and induced pluripotent stem
cells, in addition to its potential application in the treatment of a
number of conditions such as osteoarthritis, brain tumors, stroke, bone
fracture, and wounds.
The use of HyStem®-Rx as an implantable cell delivery
matrix in humans will require approval by the United States Food and
Drug Administration and comparable regulatory agencies in foreign
countries, which has not yet been obtained. Related patent applications
are pending outside of the United States in the European Union, Canada,
Japan, and Australia. Due to delays in prosecution of this patent at the
U.S. Patent and Trademark Office, a patent term extension has been
awarded, extending the expiration date to August of 2027.
For more information on OrthoCyte, please visit our website at www.orthocyte.com,
and for more information on the Glycosan product line please see www.glycosan.com.
About BioTime, Inc.
BioTime, headquartered in Alameda, California, is a biotechnology
company focused on regenerative medicine and blood plasma volume
expanders. Its broad platform of stem cell technologies is developed
through subsidiaries focused on specific fields of applications. BioTime
develops and markets research products in the field of stem cells and
regenerative medicine, including a wide array of proprietary
ACTCellerate™ cell lines, culture media, and differentiation kits.
BioTime's wholly owned subsidiary ES Cell International Pte. Ltd. has
produced clinical-grade human embryonic stem cell lines that were
derived following principles of Good Manufacturing Practice and
currently offers them for use in research. 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.
Cell Cure's minority shareholder Teva Pharmaceutical Industries has an
option to clinically develop and commercialize Cell Cure's OpRegen™
retinal cell product for use in the treatment of age-related macular
degeneration. 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
therapeutic applications of stem cell technology in cancer, including
using vascular progenitor cells engineered to destroy malignant tumors.
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 newest subsidiary, LifeMap Sciences, Inc., is
developing an online database of the complex cell lineages arising from
stem cells to guide basic research and to market BioTime’s research
products. In addition to its stem cell products, BioTime develops blood
plasma volume expanders, blood replacement solutions for hypothermic
(low temperature) surgery, and technology for use in surgery, emergency
trauma treatment and other applications. 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 Corp. under
exclusive licensing agreements. Additional information about BioTime,
ReCyte Therapeutics, Cell Cure, OrthoCyte, OncoCyte, BioTime Asia,
LifeMap Sciences, and ESI 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 the company 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
company's business, particularly those mentioned in the cautionary
statements found in the company's Securities and Exchange Commission
filings. The company 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://www.b2i.us/irpass.asp?BzID=1152&to=ea&s=0
