- PanC-Dx™Markers to be Tested Include Those
Recently Awarded Patent Protection -
ALAMEDA, Calif.--(BUSINESS WIRE)--
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.
About BioTime, Inc.
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
rebuild cell and tissue function lost due to degenerative disease or
injury. BioTime’s focus is on pluripotent stem cell technology based on
human embryonic stem (“hES”) cells and induced pluripotent stem (“iPS”)
cells. hES and iPS cells provide a means of manufacturing every cell
type in the human body and therefore show considerable promise for the
development of a number of new therapeutic products. BioTime’s
therapeutic and research products include a wide array of proprietary PureStem™
progenitors, HyStem® hydrogels, culture media, and
differentiation kits. BioTime is developing Renevia™ (a HyStem®
product) as a biocompatible, implantable hyaluronan and collagen-based
matrix for cell delivery in human clinical applications. In addition,
BioTime has developed Hextend®, a blood plasma volume
expander for use in surgery, emergency trauma treatment and other
applications. Hextend® is manufactured and distributed
in the U.S. by Hospira, Inc. and in South Korea by CJ CheilJedang
Corporation under exclusive licensing agreements.
BioTime is also developing stem cell and other products for research,
therapeutic, and diagnostic use through its subsidiaries:
• Asterias Biotherapeutics, Inc. is a new subsidiary which has acquired
the stem cell assets of Geron Corporation, including patents and other
intellectual property, biological materials, reagents and equipment for
the development of new therapeutic products for regenerative medicine.
• OncoCyte Corporation is developing products and technologies to
diagnose and treat cancer.
• Cell Cure Neurosciences Ltd. (“Cell Cure Neurosciences”) is an
Israel-based biotechnology company focused on developing stem cell-based
therapies for retinal and neurological disorders, including the
development of retinal pigment epithelial cells for the treatment of
macular degeneration, and treatments for multiple sclerosis.
• LifeMap Sciences, Inc. (“LifeMap Sciences”) markets, sells and
distributes GeneCards®, the leading human gene
database, as part of an integrated database suite that also includes the LifeMap
Discovery™ database of embryonic development, stem cell research and
regenerative medicine, and MalaCards, the human disease database.
• ES Cell International Pte Ltd., a Singapore private limited company,
developed clinical and research grade hES cell lines and plans to market
those cell lines and other BioTime research products in over-seas
markets as part of BioTime’s ESI BIO Division.
• OrthoCyte Corporation is developing therapies to treat orthopedic
disorders, diseases and injuries.
• ReCyte Therapeutics, Inc. is developing therapies to treat a variety
of cardiovascular and related ischemic disorders, as well as products
for research using cell reprogramming technology.
Additional information about BioTime can be found on the web at www.biotimeinc.com.
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'sSecurities and Exchange
Commission filings. BioTime disclaims any intent or obligation to update
these forward-looking statements.
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Lesley Stolz, 510-521-3390 ext. 367
Vice President Corporate Development
Segall, 510-521-3390 ext. 301
Source: BioTime, Inc.