Breaking News

Tweet TWEET

BioTime’s Subsidiary OncoCyte Corporation Provides an Update on the Development of the Novel Pan-Cancer Diagnostic Product

  BioTime’s Subsidiary OncoCyte Corporation Provides an Update on the
  Development of the Novel Pan-Cancer Diagnostic Product PanC-DxTM

  Multi-center clinical study of a blood-based diagnostic test for the early
                     detection of cancer planned for 2013

Business Wire

ALAMEDA, Calif. -- January 31, 2013

BioTime, Inc. (NYSE MKT: BTX) and BioTime’s subsidiary OncoCyte Corporation
provided an update on the progress of development of PanC-Dx^TM, 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-Dx^TM 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-Dx^TM 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-Dx^TM
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-Dx^TM 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-Dx^TM as an in vitro diagnostic (IVD) in Europe,
potentially commencing in 2014, before seeking FDA approval required to market
PanC-Dx^TM in the United States. Some CLIA-certified clinical laboratories may
choose to offer PanC-Dx^TM on a limited basis prior to EU and FDA approval.

“OncoCyte has made substantial progress in the development of PanC-Dx^TM 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

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.

To receive ongoing BioTime corporate communications, please click on the
following link to join our email alert list:
http://phx.corporate-ir.net/phoenix.zhtml?c=83805&p=irol-alerts

Contact:

BioTime, Inc.
Peter Garcia, 510-521-3390, ext 367
Chief Financial Officer
pgarcia@biotimemail.com
Judith Segall, 510-521-3390, ext 301
jsegall@biotimemail.com
 
Press spacebar to pause and continue. Press esc to stop.