Full Press Release Details
Inc. Subsidiary OncoCyte Corporation Initiates Clinical Development of
Bladder Cancer Diagnostics in the United States and China
to be Tested Include Those Recently Awarded Patent Protection -
ALAMEDA, Calif.--(BUSINESS WIRE)--January 27, 2014--BioTime, Inc. (NYSE
MKT: BTX) and its subsidiary OncoCyte Corporation today announced that
OncoCyte has initiated clinical development of its bladder cancer
diagnostic test in both the United States and China. In the United
States, OncoCyte has entered into a Clinical Trial Agreement with a
leading medical institution with an international reputation for
excellence and discovery, while in China, OncoCyte has entered into a
Fee-for-Service Agreement with China Medicine Inc., a contract research
organization serving nine major medical institutions, including
top-ranked university hospitals in Shanghai and Wuhan.
The goal of these clinical studies is the testing of OncoCyte's
proprietary diagnostic technology in the most common type of bladder
cancer; namely, urothelial carcinoma (UC) (previously designated
transitional cell carcinoma). Investigators in the collaborating
institutions are collecting urine samples from patients at time of
bladder cancer diagnosis as well as from those with a risk for recurrent
disease. In certain cases, current standard-of-care diagnostic
strategies such as the cellular microscopic analysis of the urine
samples will be compared with OncoCyte's proprietary markers. A
statistical analysis of these and other results will be performed to
determine the overall relative performance of OncoCyte's PanC-Dx
markers. Completion of these studies is expected by late 2014.
PanC-Dx is a class of non-invasive cancer diagnostics
based on OncoCyte's proprietary set of cancer markers. These markers
were discovered by OncoCyte scientists through an analysis of broad gene
expression patterns in numerous cancer types. The markers are the
subject of claims in numerous patent applications filed in the United
States and abroad, as well as the recently awarded Australian patent
entitled "Methods and compositions for the treatment and diagnosis of
bladder cancer." The ability of the markers tested in the studies to
determine the absence, presence, or progression of UC in patients will
determine the specific nature of the bladder cancer test to be developed
and the regulatory approval pathway that OncoCyte will pursue.
UC constitutes more than 90% of bladder cancers in the Americas, Europe
and Asia. Although most patients with bladder cancer can be treated with
organ-sparing chemotherapy, UC has a relapse rate of nearly 70% and can
progress to invasive, metastatic, and lethal disease. The regular
surveillance and treatment of recurrent disease from the time of
diagnosis for the remainder of a patient's life makes UC the most costly
malignancy on a per patient basis. The problem is amplified because the
standard of care for surveillance - microscopic assessment of urinary
cytology specimens - often lacks the sensitivity sufficient to ever
declare a patient truly disease free. While cytology does have a very
high positive predictive value (low false positive rate), it has a low
negative predictive value and a high indeterminate rate. Patients who
have indeterminate urine cytology results commonly undergo cystoscopy,
which is painful, time consuming, costly, and unnecessary in many cases
since a neoplasm is often not present. In UC, as in virtually all other
cancers, earlier and more accurate diagnosis, including diagnosis of
disease recurrence, is generally associated with better outcomes and
Overall markets for bladder cancer diagnostics are large and growing.
Based on National Cancer Institute statistics released in 2012, it is
estimated that in 2013 over 72,000 new cases of bladder cancer would
occur in the United States and a total of over 550,000 men and women
alive would have a history of bladder cancer and be subject to
recurrence surveillance testing using cystoscopy or urine cytology.
Based on data released in 2012, the overall incidence of bladder cancer
in China is 6.1 cases per 100,000 individuals; a number expected to
increase markedly in the next two decades. It is estimated that the
annual number of urine cytological analyses performed in the U.S. is
over 1.5 million, with more than 3 million tests performed annually in
the developed world.
"There is a large and growing need for more sensitive, cost-effective,
and less invasive methods to detect and monitor cancer in humans,
particularly in bladder cancer. We look forward to working with our
clinical investigators in the United States and China, a group that
includes key opinion leaders experienced in diagnostic product
development, in hopes of developing a superior test for new and
recurrent bladder cancer," said Joseph Wagner, PhD, OncoCyte's Chief
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 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 is a biotechnology company engaged in research and product
development in the field of regenerative medicine. Regenerative medicine
refers to therapies based on stem cell technology that are designed to