Full Press Release Details
Collaborators at The Wistar Institute Present Positive Clinical Interim
Results of Blood-Based Diagnostic Test for Non-Invasive Detection of
Presented at the 2015 American Thoracic Society International Conference
ALAMEDA, Calif.--(BUSINESS WIRE)--May 19, 2015--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.
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