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BioTime's Subsidiary OncoCyte Corporation Provides Update on PanC-DxTM, and Related Diagnostic Products
ALAMEDA, Calif. --(Business Wire)--
BioTime, Inc. (NYSE Amex: BTX) announced today that Joseph Wagner,
Ph.D., the CEO of BioTime's subsidiary OncoCyte Corporation and Karen B.
Chapman, Ph.D., Director of Bioinformatics will provide updates on the
development of the Company's pan-cancer diagnostic PanC-DxTM
and related diagnostics at an investor meeting in New York City. PanC-DxTM
is a screening diagnostic that may permit the use of a blood test to
screen patients for a number of solid cancer types such as those of the
breast, colon, and lung. In his presentation, Dr. Wagner will describe
the next-generation cancer diagnostics based on improved technologies in
genomics and proteomics. He will also update investors on the planned
development timeline of PanC-DxTM leading to an anticipated
product launch in Europe in late 2014.
Dr. Chapman will describe the process used by OncoCyte to generate the
novel markers of cancer. A wide array of normal human cells, normal
human tissues, tumor cell lines, and human tumors representing 20
different types of cancer were screened using novel computer algorithms
leading to the identification of more than 700 cancer-associated genes,
including genes that had not previously been associated with cancer. As
a result of this work, more than 20 patent applications have been filed.
So far, OncoCyte scientists have screened more than 60 of the marker
proteins in blood samples from cancer patients and have assembled a
multiplex platform of the most promising markers for cancer diagnosis.
Monoclonal antibodies to seven of these markers are currently under
development, and OncoCyte plans to test the newly-produced antibodies in
blood samples during the next six months. A subset of the markers
selected for inclusion in PanC-DxTM, have been applied to 50
blood samples and showed 83% sensitivity and 97% specificity in
correctly identifying breast cancer, compared to widely-used mammograms
that typically show a sensitivity rate of 70-90% and a specificity of
85-93%. OncoCyte expects that the inclusion of additional antibodies
will improve the diagnostics sensitivity and specificity further. The
relative ease and cost saving associated with a simple blood test may
make PanC-Dx an attractive alternative to a mammogram that is more
expensive, exposes the patient to radiation, and causes discomfort to
the patient.
Dr. Chapman also showed data on an additional novel single marker
designated "Marker A" which shows a high association with breast
cancers. Initial blood testing shows that the protein associated with
Marker A may distinguish breast cancer patients from normal individuals.
Dr. Wagner's and Dr. Chapman's presentations will be available for
viewing on BioTime's web site http://www.biotimeinc.com
as well as OncoCyte Corporation's web site at http://www.oncocyte.com/.
Background
There are tens of thousands of genes in the human DNA code. The pattern
of genes that are turned on or off determines the behavior of cells in
the body. BioTime developed novel methods of accurately determining the
pattern of over 40,000 gene sequences expressed in diverse types of
cells arising from embryonic stem cells and induced pluripotent stem
cells. Working together, BioTime and OncoCyte scientists identified over
700 genes associated with cancer. Of these, those which appeared to be
novel cancer-associated genes were chosen for further study.
OncoCyte's scientists subsequently determined that the patterns of the
proteins produced from a subset of these genes could be detected in the
blood of cancer patients, bt not in the blood of healthy people. The
percentage of times that the test correctly identified people as
cancer-free, which defines the test's specificity, was higher than that
of commonly used tests such as the prostate-specific antigen test for
prostate cancer. This finding, combined with initial evidence that this
prospective screening device may be useful for diagnosing a broad range
of cancer types, led BioTime and OncoCyte to prioritize the rapid
commercialization of PanC-DxTM. Another
motivation for this product focus was the rapid growth of the oncology
diagnostics market, which according to data from Business Insights, Ltd.
is estimated to reach US $8.14 billion by 2014, thus outpacing the
growth of the general diagnostics market.
OncoCyte intends to initially develop and market PanC-DxTM
in Europe before seeking regulatory approvals required to market the
product in the United States and other countries. A blood screening test
for cancer markers meets the definition of an in vitro diagnostic
product as defined in the European Directive on in vitro
diagnostic medical devices (IVD). Under this directive, IVD products
placed into the European market must bear the CE mark, which indicates
the product is in conformity with all applicable requirements of safety,
performance, instructions, markings, and quality sufficient for the safe
and effective use of the product.
PanC-DxTM is classified as a General IVD under
the IVD directive. The CE marking process is accomplished by a
self-declaration of conformity with the requirements of the directive.
Working with the British Standards Institute, OncoCyte will be pursuing
full medical device quality system certification, which should be
achieved by the fourth quarter of 2014.
About OncoCyte Corporation
OncoCyte Corporation is a majority-owned privately-held subsidiary of
BioTime, Inc. OncoCyte's mission is to develop novel products for the
diagnosis and treatment of cancer based on embryonic stem cell-derived
technology in order to improve both the quality and length of life of
cancer patients. OncoCyte's molecular diagnostics division is developing
products that should provide for earlier detection and more effective
treatment of numerous cancers. In addition to its diagnostic product
line, OncoCyte is developing cellular therapies to treat cancer based on
the unique biology of vascular precursor cells. The goal of OncoCyte's
therapeutic research efforts is to derive vascular cells that can be
engineered to deliver a toxic payload to the developing blood vessels of
a malignant tumor to destroy the tumor without killing nearby normal
tissues in the body. Additional information on OncoCyte can be found on
the web at www.oncocyte.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
diagnostic and therapeutic applications of stem cell technology in
cancer, including the diagnostic product PanC-DxTM
currently being developed for the detection of cancer in blood samples,
and therapeutic strategies 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 (News - Alert)
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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