BioTime, Inc. (NYSE MKT:BTX) and its subsidiary OncoCyte Corporation
today announced initial data from a large, prospective clinical study
that showed the potential of PanC-Dx™, OncoCyte’s non-invasive
diagnostic technology based on its proprietary set of cancer markers, as
a non-invasive, blood-based diagnostic test to screen for multiple types
of human cancers, including breast cancer. The early data showed the
utility of the protein Collagen Type X (COL10A1) in distinguishing
patients with malignant breast lesions from those with negative
findings. The clinical data was presented by Maria Prendes, PhD,
Director of Manufacturing at OncoCyte, at the American Association for
Cancer Research (AACR) Annual Meeting during a poster presentation from
8:00 AM -12:00 PM EDT on Monday, April 20, 2015.
The controlled study, initiated at Scottsdale Medical Imaging
Laboratories in Scottsdale, AZ, is ongoing and has nearly completed
enrollment of over 600 patients. The goal of this study is to assess the
performance of PanC-Dx™ in discriminating patients with malignant
breast lesions from those with negative findings or benign findings.
Study investigators are collecting blood samples from patients
undergoing screening or diagnostic mammography. Patient blood samples
are being assessed for levels of OncoCyte’s PanC-Dx™ markers,
including the concentration of the protein COL10A1, using proprietary
assays and the results are compared to radiological and pathology
findings. Expression of the gene COL10A1 at an mRNA level has
been shown in past studies to be significantly elevated in multiple and
diverse malignant tumor types including cancers of the breast, stomach,
colon, lung, bladder, pancreas, and ovaries. In addition, the protein
was shown to be specifically localized within tumor vasculature.
Early data showed that PanC-Dx™ identified a mean concentration
of COL10A1 protein in sera of breast cancer patients (n=33) that was 35%
higher than the mean COL10A1 value in sera of normal individuals (n=32).
No significant differences were noted when comparing breast cancer
patients to patients with confirmed benign disease suggesting that
additional biomarkers may be necessary to discriminate these two
populations. Based on this data, PanC-Dx™ offered improved
performance as compared to the commercially available enzyme-linked
immunosorbent assay (ELISA) manufactured with polyclonal antibodies that
study investigators previously used in analyzing over 400 serum samples
from healthy volunteers and cancer patients. Evaluation of the
performance of PanC-Dx™ demonstrated 86% area-under-the-curve
(AUC) of the Receiver Operating Characteristic (ROC) curve, which
determines the level of specificity and sensitivity of the product. The
polyclonal ELISA demonstrated 74% AUC of the ROC curve.
“These early data suggest the potential of PanC-Dx™ and COL10A1
protein as a blood-based diagnostic and biomarker that could prove
useful in non-invasive, early detection of a wide variety of cancers,
including breast cancer,” said Joseph Wagner, PhD, OncoCyte’s Chief
Executive Officer. “We are excited by the opportunity of developing PanC-Dx™
as a simple, radiation-free alternative for breast cancer detection for
millions of women whose dense breast tissue makes their mammograms less
accurate. Study investigators are testing other markers in the same
patient samples that could increase accuracy for breast cancer
detection. In addition, we are encouraged by the potential for PanC-Dx™
to detect COL10A1 protein levels with greater sensitivity and
specificity than current commercially available assays.”
In 2010 over 30 million screening mammograms were performed in the U.S.
alone. The American Cancer Society and the National Comprehensive Cancer
Network both recommend screening mammography every year starting at age
40, which has been associated with relative reduction in breast cancer
mortality of 15% to 20%. However, the NCI estimates that approximately
20% of all breast cancers are not detected by mammography during annual
screening, which indicates that there is an unmet need for a
breast-cancer screening test with superior specificity and sensitivity
when compared to standard screening mammography.
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. 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, which are completing initial clinical studies for
bladder, breast, and lung cancer. AST-VAC2, a cancer vaccine, is
in the pre-clinical trial stage.
BioTime’s subsidiaries include: 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
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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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