BioTime CEO Dr. Michael West Presents Product Development Update at World
Stem Cell Summit 2012
World Stem Cell Summit 2012
ALAMEDA, Calif. -- December 04, 2012
BioTime, Inc. (NYSE MKT: BTX), a biotechnology company that develops and
markets products in the field of regenerative medicine, announced that Chief
Executive Officer Michael D. West, Ph.D. will provide an update today on five
products being developed by BioTime and its subsidiaries during a presentation
at the World Stem Cell Summit 2012 in West Palm Beach, Florida in the session
on “Developing Combination Products: Cells, Genes, and Devices” at 1:30 pm
EST. The presentation will be made available on BioTime's website at
BioTime’s technology platform utilizes pluripotent stem cells that are capable
of differentiating into any of the cell types in the body to produce
potentially novel first-in-class regenerative therapies for largely unsolved
problems in medicine. Using the Company’s proprietary ACTCellerate^TM
technology, BioTime has more than 200 novel and scalable cellular components
of the human body.
Dr. West will present for the first time information relating to 18 novel and
diverse progenitor cell lines capable of differentiating into diverse
cartilage and bone types, as well as producing cells with markers of tendon,
and brain meningeal tissues. The cartilage progenitor formulation designated
OTX-CP07 is being developed by BioTime’s subsidiary OrthoCyte Corporation, and
is currently beginning the process of animal studies of safety and efficacy
for the treatment of intervertebral disc disease. The cartilage, bone, and
tendon-producing cell lines may have significant applications in the treatment
of orthopedic disorders such as osteoarthritis and low back pain resulting
from intervertebral disc disease, while the subset of lines capable of choroid
plexus differentiation may have application in the treatment of Alzheimer’s
For many of the wide array of cell-based regenerative therapies being
developed around the world, the formulation of the cells with a matrix is
desired to increase viable and immobilized engraftment. Renevia™ is designed
to be an effective means of transplanting cells in an injectable liquid that
can polymerize safely in the body into a tissue construct. Dr. West will
report that validation of the analytical methods and manufacturing processes
for Renevia™ are substantially complete. Production of one of Renevia’s™ four
manufacturing components under Current Good Manufacturing Practice (cGMP) is
completed and cGMP production of the remaining three components is scheduled.
Clinical trial protocols (three phases) are being drafted and BioTime
anticipates that during the first quarter of 2013 a submission of the Renevia™
Phase I safety trial in humans will be made to the appropriate Spanish Ethics
Committee for review and approval. In addition, he will report continued
progress on establishing quality management systems for compliance with ISO
13485 (required in the EU for medical devices) and that preliminary review and
audit (by an external auditor) is currently scheduled for the first quarter of
2013 with the final ISO audit expected during the second quarter.
PanC-Dx™, being developed by BioTime’s subsidiary OncoCyte Corporation, is
intended to be a blood-based screening diagnostic for a wide array of solid
tumor types. Recent reports of the relative ineffectiveness of mammography in
reducing patient death from breast cancer highlight the urgent need for
improved tools to accurately detect the disease in its earliest stages. Dr.
West will report that OncoCyte has initiated production of monoclonal
antibodies to the first seven of its priority cancer markers. In addition,
OncoCyte has completed the characterization of over 50 antibodies in order to
screen for the subset with greatest specificity for each individual marker.
Dynamic testing of the antibodies for use in ELISA and point of care formats
are currently underway.
OpRegen^® and OpRegen-Plus^® Update
Dr. West will describe the current need for retinal pigment epithelial (RPE)
cells free of animal products for the treatment of the dry form of age-related
macular degeneration (AMD). Dr. West will discuss how such cells could aid in
eliminating the need for designating a product as a xenotransplantation
therapeutic. Dr. West will describe the ongoing preclinical studies at
BioTime’s subsidiary Cell Cure Neurosciences Ltd., which are expected to lead
to regulatory filings for the initiation of human clinical trials in 2013.
World Stem Cell Summit 2012 will be the 8th annual event produced by the
Genetics Policy Institute (GPI), a non-profit organization. Planned by and for
the stem cell and regenerative medicine community, the goal of the Summit is
to accelerate the discovery and development of lifesaving cures and therapies.
This year, panels will address advancing treatments for specific diseases and
conditions including: cancer, diabetes, HIV/AIDS, cardiovascular disease,
spinal cord injury, paralysis, multiple sclerosis, ALS, Parkinson's, eye
diseases and others.
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, and has developed
an integrated database suite to complement GeneCards^® that will include the
LifeMap Discovery™ database of embryonic development, stem cell research and
regenerative medicine, and MalaCards, the human disease database. LifeMap is
also marketing BioTime research products. 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.
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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