- Final Study Enrollment Exceeds 600 Patients -
ALAMEDA, Calif.--(BUSINESS WIRE)--Oct. 3, 2014--
BioTime, Inc. (NYSE MKT: BTX), and its subsidiary OncoCyte Corporation
today announced that OncoCyte’s collaborators at The Wistar Institute
have completed enrollment of a large, multi-site study evaluating a
blood-based lung cancer diagnostic test. OncoCyte previously entered
into a Sponsored Research Agreement and a Material Transfer Agreement
with The Wistar Institute to collaboratively develop lung cancer
diagnostic products approximately one year ago. As part of the clinical
study, over 600 blood samples were obtained from patients with a
high-risk profile for development of lung cancer at six clinical sites.
Enrollment was completed in June with all sites meeting or exceeding
their collection goals. Wistar investigators are currently assessing
gene expression patterns in blood cells of patients with malignant
versus non-malignant lung disease. The analysis of patient data from
this study should be completed by the end of October with submission of
the study results for publication in a peer-reviewed journal to follow.
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.
As part of the Sponsored Research Agreement, OncoCyte has an option to
exclusively license any inventions, discoveries or technology developed
by Wistar, or by OncoCyte using Wistar technology, in the course of the
collaborative research and anticipates exercising this exclusive option
if final results of the study are positive.
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. Annual screening for lung cancer in certain high-risk
patients was recently recommended by the United States Preventative
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 high false-positive rate of approximately 25%.
“I look forward to continuing our collaboration with the OncoCyte team
on the validation of blood-based molecular markers for the diagnosis of
cancer. This collaboration has been quite positive for both groups,”
said Dr. Showe, a professor in the Molecular and Cellular Oncogenesis
program of Wistar’s NCI-designated Cancer Center. “Our recent completed
enrollment of 600-plus patients to this study uses a sample collection
system much more amenable to clinical settings than our previous study.
The need for more sensitive, cost-effective, and less invasive methods
to detect and monitor cancer in humans, particularly in lung cancer is
not going away. The present study also expands on the small study we
previously reported by further examining changes in peripheral blood
signatures after tumor removal to assess the potential to detect early
recurrences. Our results also suggest a negative effect on survival
linked to a myeloid cell derived gene signature suggesting inhibitory
effects of immune suppressor cells, a present topic of great interest.
We look forward to expanding our studies through this collaboration in
order to detect and monitor this devastating cancer.”
“I have truly been impressed by the level of focus and execution
demonstrated by our collaborators at The Wistar Institute over the past
year. Dr. Showe and her team have delivered a rigorous clinical study on
time while enrolling a greater than expected number of patients. I look
forward to our second year of working together during which I believe
our focus will shift toward full commercial development of a blood-based
lung cancer diagnostic test for use in patients with a high risk for the
disease. Large scale screening of this population, estimated to
represent at least three 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 would 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,” 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. 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 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.
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®
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, and is planning to initiate a
pivotal clinical trial around Renevia™, in 2014. 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 HealthCare Corporation, under exclusive licensing agreements.
BioTime is also developing stem cell and other products for research,
therapeutic, and diagnostic use through its subsidiaries:
Biotherapeutics, Inc. is developing pluripotent stem-cell
based therapies in neurology and oncology, including AST-OPC1
oligodendrocyte progenitor cells in spinal cord injury, multiple
sclerosis and stroke, and AST-VAC2, an allogeneic dendritic cell-based
cancer vaccine. Asterias trades publicly under the symbol ASTY.
BioTime Asia, Ltd., a Hong Kong company, may offer and sell
products for research use for BioTime’s ESI BIO Division.
Cure Neurosciences Ltd. 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.
BIO is the research and product marketing division of BioTime,
providing stem cell researchers with products and technologies to
enable them to translate their work into the clinic, including PureStem®
progenitors and HyStem® hydrogels.
Sciences, Inc. 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.
Solutions, Inc. is a subsidiary of LifeMap Sciences focused on
developing mobile health (mHealth) products.
Corporation is developing products and technologies to diagnose and
treat cancer, including PanC-Dx™, with three clinical trials
Corporation is developing therapies to treat orthopedic disorders,
diseases and injuries.
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.
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Source: BioTime, Inc.
Judith Segall, 510-521-3390, ext 301