- PanC-DxTM Markers to be
Tested in Multi-Center Lung Cancer Study Currently Underway -
ALAMEDA, Calif.--(BUSINESS WIRE)--Oct. 15, 2013--
BioTime, Inc. (NYSE MKT: BTX), and its subsidiary OncoCyte Corporation
today announced that OncoCyte has entered into a Sponsored Research
Agreement and a Material Transfer Agreement with The Wistar Institute to
collaboratively develop lung cancer diagnostic products. As part of the
collaboration, Wistar investigators are conducting a multi-center
patient study in which they are assessing gene expression patterns in
blood cells of patients with malignant versus non-malignant lung
disease. OncoCyte scientists will analyze blood samples obtained from
patients in the study to determine levels of tumor-associated proteins
using its proprietary PanC-Dx™ diagnostic tests. 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 inclusion of the PanC-DxTM markers in
Wistar's ongoing multi-center study may allow OncoCyte to more rapidly
develop a diagnostic test for lung cancer to be marketed in the U.S. and
other countries. The performance of markers tested in the study in
determining the presence or the progression of disease in various
categories of patients may determine the specific nature of the lung
cancer test to be developed and the regulatory approval pathway that
OncoCyte will pursue. OncoCyte will have an option to exclusively
license any inventions, discoveries or technology developed by Wistar,
or by OncoCyte using Wistar technology, in the course of the
Wistar investigators, led by Louise Showe, Ph.D., have previously
demonstrated the feasibility of detecting early stage lung cancer by
taking a snapshot of gene activity in circulating blood cells. 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. The current study is being conducted on patients
recruited through grant partners at multiple clinical sites. Thus far
over 400 patient samples out of a planned total of 600 have been
obtained. Completion of the study, which began mid-2012, is expected in
“I look forward to collaborating with the OncoCyte team to validate
blood-based molecular markers for the diagnosis of cancer,” said Dr.
Showe, a professor in the Molecular and Cellular Oncogenesis program of
Wistar’s NCI-designated Cancer Center. “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 lung cancer. In
addition to the development of a diagnostic gene panel, our previous
studies provided new insights into the interactions of cancer and the
immune system. We look forward to expanding those studies through this
“We are impressed by the quality of the genomics and bioinformatics
capabilities at The Wistar Institute. These capabilities, combined with
Wistar’s ongoing access to patient samples, are expected to accelerate
the development of a blood-based lung cancer diagnostic and
strategically fits into our overall PanC-Dx™ development
strategy,” said Joseph Wagner, PhD, OncoCyte’s Chief Executive Officer.
OncoCyte has previously published in peer-reviewed scientific journals
data relating to two PanC-Dx™ markers: COL10A1, a marker
associated with the vasculature of numerous solid tumors, and FSIP1,
a marker unique to breast cancer.
“We believe the formula for leadership in the emerging field of
regenerative medicine is to have a balanced product development strategy
that includes both products like PanC-Dx™ that may be developed
and commercialized in the near term, and therapeutic products derived
from pluripotent stem cell technology that will require a longer path to
commercialization but that have the potential to successfully treat
large patient populations with high unmet medical needs. OncoCyte's
diagnostic patient study collaboration with the Wistar Institute is one
component of that strategy, as is the recent entry in to human clinicals
of Renevia™, and the development of pluripotent stem cell
therapies at some of our subsidiaries, including Asterias
Biotherapeutics, Inc. and Cell Cure Neurosciences Ltd.,” said Dr.
Michael West, BioTime's Chief Executive Officer.
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. The Wistar Institute: Today’s
Discoveries – Tomorrow’s Cures. On the Web at www.wistar.org.
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:
OncoCyte Corporation is developing products and technologies to
diagnose and treat cancer.
ES Cell International Pte Ltd., a Singapore private limited company,
develops hES products for research use.
BioTime Asia, Limited, a Hong Kong company, sells products for
research use and may develop therapies to treat cancer, neurological,
and orthopedic diseases.
OrthoCyte Corporation is developing therapies to treat orthopedic
disorders, diseases and injuries.
ReCyte Therapeutics, Inc. is developing therapies to treat a variety
of blood and lymphatic vascular disorders, as well as products for
research using iPS and other cell reprogramming technology.
Cell Cure Neurosciences Ltd. is an Israel-based biotechnology company
focused on developing stem cell-based therapies for retinal and
neurological degenerative diseases. Its lead product is OpRegen®
for the treatment of macular degeneration.
LifeMap Sciences, Inc. markets, sells and distributes GeneCards®,
the leading human gene database, 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. LifeMap Sciences also markets BioTime research products and PanDaTox,
an innovative, recently developed, searchable database that can aid in
the discovery of new antibiotics and biotechnologically beneficial
Asterias Biotherapeutics, Inc. is a new subsidiary that recently
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
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's Securities and Exchange
Commission filings. BioTime disclaims any intent or obligation to update
these forward-looking statements.
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Source: BioTime, Inc.
Lesley Stolz, PhD, 510-521-3390, ext. 367
Vice President, Corporate Development
510-521-3390, ext. 301