Data Presented at the 2015 American Thoracic
Society International Conference
BioTime, Inc. (NYSE MKT:BTX) and its subsidiary OncoCyte
Corporation today announced the presentation of positive interim
clinical results demonstrating the high level of observed
sensitivity and specificity in the assayed samples of a simple
blood-based test designed to aid physicians in the early detection
of lung cancer. The large, prospective clinical study was conducted
by The Wistar Institute, an international leader in basic
biomedical research. The test was developed in the laboratory of
Louise Showe, PhD, professor in the Molecular and Cellular
Oncogenesis program of The Wistar Institute’s NCI-designated cancer
center. Andrew Kossenkov, PhD, a senior member of Dr. Showe’s
laboratory and Managing Director of Wistar’s Bioinformatics
Facility, will present interim results from the study at the
American Thoracic Society (ATS) International Conference during an
oral presentation beginning at 2:45 PM MDT on Tuesday, May 19,
2015.
As part of the study, clinical investigators used a simple
collection system that is approved by the U.S. Food and Drug
Administration (FDA) to prepare over 600 peripheral blood samples
from patients determined to be at high risk for developing lung
cancer based on age and smoking history. These patients were
undergoing either low-dose computed tomography (CT) scanning for
lung cancer or were recently diagnosed with lung cancer. Wistar
scientists then assessed the expression of messenger RNA and micro
RNA in the initial training set of 242 samples and developed a
classifier of 145 markers (125 mRNAs plus 20 micro RNAs) that most
accurately distinguished patients with malignant nodules from those
with benign or no findings. The classifier was then assessed in an
independent test set of 103 samples. Performance of the classifier
was evaluated using several criteria, including Receiver Operating
Characteristic (ROC) area under the curve (AUC) analysis, and
yielded an AUC of 0.88 (sensitivity of 76% with a specificity of
88%) in the test set. Analysis of the full patient sample set is
near completion.
In October 2013, OncoCyte entered into a Sponsored Research
Agreement with The Wistar Institute to identify, develop and test
potential lung cancer biomarkers collaboratively with Dr. Showe’s
laboratory. OncoCyte has exercised options to obtain exclusive
licenses to any inventions, discoveries or technology developed in
the course of the collaborative research, including the technology
presented today at the ATS International Conference, and expects to
negotiate definitive license agreements with Wistar.
Lung cancer remains a primary cause of cancer-related death in
part because there is no effective diagnostic test to screen
patients for lung cancer at an early stage. Annual screening for
lung cancer in certain high-risk patients was recently recommended
by the United States Preventive Services Task Force (USPSTF), an
independent panel of experts in primary care and prevention that
systematically reviews the evidence of effectiveness and develops
recommendations for clinical preventive services. The Task Force
recommended screening using low-dose computed tomography (CT).
Although low-dose CT has demonstrated high sensitivity in detecting
early-stage lung cancer in large clinical studies, it also has a
relatively high false-positive rate of approximately 25%. False
positives can lead to unnecessary costs and side effects because of
the need for invasive diagnostic procedures such as lung
biopsies.
“Large-scale screening of patients at high risk for lung cancer,
estimated to represent over seven million patients per year in the
United States, could reduce overall lung cancer mortality through
earlier detection. However, the high number of false-positive
low-dose CT tests could lead to over a billion dollars a year in
unnecessary costs to the United States health care system as a
result of associated follow-up testing. Physicians, payers, and
patients may therefore welcome a simple to use, low-cost,
blood-based test that can help guide patient-management decisions
by noninvasively ruling out the presence of cancer. The data
presented today by our Wistar collaborators demonstrates that a
high performance, blood-based screening diagnostic for the early
detection of lung cancer may be attainable,” said Joseph Wagner,
PhD, OncoCyte’s Chief Executive Officer.
About OncoCyte Corporation
OncoCyte, a majority-owned subsidiary of BioTime, Inc., is
developing novel products for the diagnosis and treatment of cancer
in order to improve the quality and length of life of cancer
patients. Based on large unmet need, market size, and data
generated thus far from patient sample screening, OncoCyte is
initially focusing its efforts on developing PanC-Dx™ diagnostic
products for use in detecting breast, bladder, and lung cancers.
PanC-Dx™ is a class of non-invasive cancer diagnostics based on a
proprietary set of cancer markers characterized, in part, by broad
gene expression patterns in numerous cancer types. The PanC-Dx™
biomarkers were discovered as a result of ongoing research within
OncoCyte and BioTime on the gene expression patterns associated
with embryonic development. Additional markers were discovered by
collaborators as the Wistar Institute. This research has
demonstrated that many of the same genes associated with normal
growth during embryonic development are abnormally reactivated by
cancer cells. These genes regulate such diverse processes as cell
proliferation, cell migration and blood vessel formation. Many of
these genes have not been previously associated with cancer.
Moreover, expression of a large subset of these genes is conserved
across numerous cancer types (e.g. cancers of the breast, colon,
ovaries, etc.), suggesting these genes may control fundamental
processes during cancer growth and progression. In addition to
their potential value in developing diagnostic biomarkers, an
understanding of the pattern of expression of these genes may also
enable the development of powerful new cancer therapeutics that
target rapidly proliferating cancer cells.
About BioTime
BioTime, Inc., a pioneer in regenerative medicine, is a
clinical-stage biotechnology company. BioTime and its subsidiaries
are leveraging their industry-leading experience in pluripotent
stem cell technology and a broad intellectual property portfolio to
facilitate the development and use of cell-based therapies and gene
marker-based molecular diagnostics for major diseases and
degenerative conditions for which there presently are no cures. The
lead clinical programs of BioTime and its subsidiaries include
OpRegen®, currently in a Phase I/IIa trial for the treatment of the
dry form of age-related macular degeneration; AST-OPC1, currently
in a Phase I/IIa trial for spinal cord injuries; Renevia™,
currently in a pivotal trial in Europe as an injectable matrix for
the engraftment of transplanted cells to treat HIV-related
lipoatrophy; and PanC-Dx™ cancer diagnostics, nearing the
completion of initial clinical studies for the detection of
bladder, breast, and lung cancers. AST-VAC2, a cancer vaccine, is
in the pre-clinical trial stage.
BioTime’s subsidiaries include the publicly traded Asterias
Biotherapeutics, Inc. (NYSE MKT:AST), developing pluripotent stem
cell-based therapies in neurology and oncology, including AST-OPC1
and AST-VAC2; Cell Cure Neurosciences Ltd., developing stem
cell-based therapies for retinal and neurological disorders,
including OpRegen®; OncoCyte Corporation, developing PanC-Dx™
cancer diagnostics; LifeMap Sciences, Inc., developing and
marketing an integrated on-line database resource for biomedical
and stem cell research; LifeMap Solutions, Inc., a subsidiary of
LifeMap Sciences, developing mobile health (mHealth) products; ES
Cell International Pte Ltd, which has developed cGMP-compliant
human embryonic stem cell lines that are being marketed by BioTime
for research purposes under the ESI BIO branding program; OrthoCyte
Corporation, developing therapies to treat orthopedic disorders,
diseases and injuries; and ReCyte Therapeutics, Inc., developing
therapies to treat a variety of cardiovascular and related ischemic
disorders.
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+.
About The Wistar Institute
The Wistar Institute is an international leader in biomedical
research with special expertise in cancer research and vaccine
development. Founded in 1892 as the first independent nonprofit
biomedical research institute in the country, Wistar has long held
the prestigious Cancer Center designation from the National Cancer
Institute. The Institute works actively to ensure that research
advances move from the laboratory to the clinic as quickly as
possible. Wistar Science Saves Lives. On the Web at
www.wistar.org.
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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version on businesswire.com: http://www.businesswire.com/news/home/20150519005819/en/
BioTime, Inc.Judith Segall, 510-521-3390, ext
301jsegall@biotimemail.comorInvestor Contact:EVC Group, Inc.Michael
Polyviou, 212-850-6020mpolyviou@evcgroup.com
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