BioTime’s Subsidiary OncoCyte Corporation Provides an Update on the Development of the Novel Pan-Cancer Diagnostic Product PanC-DxTM
BioTime, Inc. (NYSE MKT: BTX) and BioTime’s subsidiary OncoCyte
Corporation provided an update on the progress of development of PanC-DxTM,
a novel blood-based diagnostic test utilizing molecular markers
discovered at BioTime and OncoCyte designed to detect the presence of
various human cancers, including cancers of the breast, lung, bladder,
uterus, stomach, and colon. By facilitating early, non-invasive cancer
detection, PanC-DxTM could lead to more successful
therapeutic outcomes through earlier diagnosis and treatment. This
diagnostic test could also reduce the cost of cancer monitoring and
increase the availability of affordable cancer screening worldwide.
OncoCyte first announced the development of PanC-DxTM
during December 2011 and last provided a progress update in March 2012.
In addition to this update, OncoCyte intends to release additional
information regarding the progress of PanC-DxTM
development throughout 2013.
OncoCyte’s plans for 2013 include the initiation of a clinical study
focused on breast cancer screening at a group of leading cancer research
institutions. OncoCyte has been developing, characterizing, and
manufacturing monoclonal antibodies in preparation for the initiation of
the clinical study and is currently working with a select group of
cancer researchers to design the trial and select the study sites. If
its laboratory findings are validated in clinical trials, PanC-DxTM
may be used as a simple, routine blood test that could be performed in
women of any age at any desired frequency to detect breast cancer with
as much if not better accuracy and with less cost than a conventional
mammogram.
OncoCyte has achieved several key advances in the past year, including:
-
Completion of the development and characterization of over 50
proprietary, patent pending, monoclonal antibodies targeting 7 novel
cancer antigens. OncoCyte’s findings show a significant elevation of
these antigens in the blood of cancer patients when compared to
healthy control patients;
-
Initiation of validation studies of ELISA assays in order to
demonstrate high-sensitivity detection of target antigens using
proprietary monoclonal antibodies;
-
Completion of large-scale manufacturing of 11 proprietary monoclonal
antibodies;
-
Initiation of prototype development for a second detection format
(solid phase ELISA point of care testing) through a collaborative
development agreement; and
-
Initiation of clinical trial protocol design analysis in consultation
with key opinion leaders and outside diagnostic experts.
Key goals for 2013 will be:
-
Completion of validation of our proprietary ELISAs in our patient
sample dataset;
-
Formalization of additional relationships with key opinion leaders at
major medical institutions;
-
Institutional review board (IRB) approval and initiation of a large,
prospective multicenter patient study at leading breast cancer
institutions;
-
Presentation of key findings at major oncology-related scientific
conferences; and
-
Submission of manuscripts to peer-reviewed scientific journals for
publication.
Based on large unmet need, market size, and data generated thus far from
patient sera screening, OncoCyte is initially focusing its efforts on
biomarkers associated with breast cancer. The apparent high correlation
of certain combinations of biomarkers in breast cancer has made this
indication an attractive initial target. If clinical trials are
successful, OncoCyte intends to launch PanC-DxTM as an
in vitro diagnostic (IVD) in Europe, potentially commencing in 2014,
before seeking FDA approval required to market PanC-DxTM
in the United States. Some CLIA-certified clinical laboratories may
choose to offer PanC-DxTM on a limited basis prior to
EU and FDA approval.
“OncoCyte has made substantial progress in the development of PanC-DxTM
since our last update in March of 2012,” said Joseph Wagner, Ph.D., CEO
of OncoCyte. “Most importantly, we have developed and characterized a
large repertoire of proprietary monoclonal antibodies to a set of breast
cancer-related protein markers that we have identified and validated
over the last few years. OncoCyte has filed patent applications on these
novel, unique markers that we believe are early indicators of the
presence of breast cancer. We have manufactured substantial quantities
of a subset of these proprietary antibodies that show the greatest
promise and we are currently assembling ELISA-format assays. Once we
have completed the validation of these assays and our clinical trial
design work, we intend on initiating a large, multicenter clinical trial
later this year.”
“There is a great need for rapidly deployed, effective screens to
identify a wide array of human cancers at their earliest stages. A
blood-based test with superior accuracy designed to detect breast cancer
at early stages would have a substantial impact in the women’s health
community,” said Dr. Andrew von Eschenbach, former Director of the U.S.
National Cancer Institute and former U.S. Food and Drug Administration
Commissioner. Dr. von Eschenbach, a specialist in urological cancer, is
a member of the BioTime and OncoCyte boards of directors. “Early
detection remains our current best hope for achieving cures. Therefore,
the development of more accurate diagnostics and screens for all major
cancer types should be a national priority.”
Michael West, Ph.D., CEO of BioTime added, “We are pleased with the deep
insights into cancer biology generated by this discovery effort. These
discoveries were the direct outcome of the broad regenerative medicine
and bioinformatics platform that has been built at the BioTime family of
companies and demonstrates the breadth of potential applications of our
technology. Besides leading to novel diagnostics, these new insights may
point the way to future therapeutic strategies to target and destroy
cancer cells while leaving normal tissue intact.”
About BioTime, Inc.
BioTime, headquartered in Alameda, California, is a biotechnology
company focused on regenerative medicine and blood plasma volume
expanders. Its broad platform of stem cell technologies is enhanced
through subsidiaries focused on specific fields of application. BioTime
develops and markets research products in the fields of stem cells and
regenerative medicine, including a wide array of proprietary PureStem™
cell lines, HyStem® hydrogels, culture media, and
differentiation kits. BioTime is developing Renevia™ (formerly
known as HyStem®-Rx), a biocompatible,
implantable hyaluronan and collagen-based matrix for cell delivery in
human clinical applications. BioTime's therapeutic product development
strategy is pursued through subsidiaries that focus on specific organ
systems and related diseases for which there is a high unmet medical
need. BioTime's majority owned subsidiary Cell Cure Neurosciences Ltd.
is developing therapeutic products derived from stem cells for the
treatment of retinal and neural degenerative diseases. BioTime's
subsidiary OrthoCyte Corporation is developing therapeutic applications
of stem cells to treat orthopedic diseases and injuries. Another
subsidiary, OncoCyte Corporation, focuses on the diagnostic and
therapeutic applications of stem cell technology in cancer, including
the diagnostic product PanC-Dx™ currently being developed for the
detection of cancer in blood samples. ReCyte Therapeutics, Inc. is
developing applications of BioTime's proprietary induced pluripotent
stem cell technology to reverse the developmental aging of human cells
to treat cardiovascular and blood cell diseases. BioTime's subsidiary
LifeMap Sciences, Inc. markets 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. 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 products. BioTime
Acquisition Corporation is a new subsidiary being used to acquire 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.
BioTime's lead product, Hextend®, is a blood plasma
volume expander manufactured and distributed in the U.S. by Hospira,
Inc. and in South Korea by CJ CheilJedang Corporation under exclusive
licensing agreements. Additional information about BioTime can be found
on the web at www.biotimeinc.com.
About OncoCyte Corporation
OncoCyte Corporation is a majority-owned subsidiary of BioTime, Inc.
OncoCyte's mission is to develop novel products for the diagnosis and
treatment of cancer in order to improve both the quality and length of
life of cancer patients. OncoCyte's molecular diagnostics division is
developing products for earlier detection of a variety of cancers. In
addition to its diagnostic product line, OncoCyte is developing cellular
therapies to treat cancer based on the unique biology of vascular
precursor cells. The goal of OncoCyte's therapeutic research efforts is
to derive vascular cells that can be engineered to deliver a toxic
payload to the developing blood vessels of a malignant tumor to destroy
the tumor without killing nearby normal tissues in the body. Additional
information on OncoCyte can be found on the web at www.oncocyte.com.
Forward-Looking Statements
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other statements about the future expectations, beliefs, goals, plans,
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