Full Press Release Details
CEO Dr. Michael West Presents Product Development Update at World Stem
ALAMEDA, Calif.--(BUSINESS WIRE)--December 4, 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 www.biotimeinc.com.
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 ACTCellerateTM
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 disease.
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
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
OpRegen and OpRegen-Plus
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.
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