Full Press Release Details
Submits Protocol for Initiation of Human Clinical Trials of Renevia
ALAMEDA, Calif.--(BUSINESS WIRE)--January 10, 2013--BioTime, Inc. (NYSE
MKT: BTX), a biotechnology company that develops and markets products in
the field of regenerative medicine, today announced it has submitted a
Clinical Investigation Protocol (CIP) to European regulatory authorities
for approval to initiate studies for its Renevia stem
cell delivery platform. The Principal Investigator for the studies will
be Ramon Llull, MD, and the planned trials will be conducted at the Stem
Center, Palma de Mallorca, Spain (www.stem-center.com). The Stem
Center is operated by the GID Group, Inc., of Louisville, Colorado.
BioTime is currently completing the production of clinical materials
according to current Good Manufacturing Practice regulations. The
initiation of human clinical studies is expected in Q2 of this year upon
approval of the CIP.
Renevia , a member of the Company's HyStem
family of hydrogels, is a proprietary formulation that
mimics the human extracellular matrix, a web of molecules surrounding
cells that is essential to cellular function. Renevia is designed to be
a liquid injectable matrix capable of safely polymerizing in the body
into a three-dimensional tissue-like scaffold in combination with
transplanted cells. Anchoring the transplanted cells in such a
biocompatible matrix generally increases the percentage of viable cell
engraftment. HyStem hydrogels are currently
being used by researchers at a number of leading medical schools in
laboratory studies to investigate a broad array of stem cell therapies,
including wound healing, treatment of ischemic stroke, brain cancer,
vocal fold scarring, and cardiac infarct. Videos describing the
technology by the inventor Glenn Prestwich, PhD, are available for
viewing online at www.biotimeinc.com/corporate-videos/.
"This is an important step forward in our commercialization efforts and
brings us closer to delivering this much-needed matrix technology for
the emerging field of regenerative medicine," stated William P. Tew,
PhD, Chief Commercialization Officer of BioTime, Inc. "The technology
forms a foundation for the delivery of cell-based therapeutic products
in both the adult and embryonic stem cell marketplace. Current
preclinical studies at leading medical institutions have shown that HyStem
hydrogels are compatible with a wide variety of tissue types including
brain, bone, skin, nerve, cartilage, and heart."
In the clinical application described in this CIP, Renevia
will be used as a delivery matrix for autologous adipose cells in
order to restore subcutaneous tissue lost as a result of injury,
oncologic resection, or congenital defects. Restoration of the normal
skin contour is an important quality-of-life issue, not only in elective
cosmetic procedures, but also in reconstructive surgeries needed to
repair deformities and traumatic injuries to the face and upper
extremities. BioTime's plan is to bring Renevia to
the medical market first in the European Union, where the regulatory
pathway will allow for faster approval. Once the use of Renevia
is established in Europe, BioTime plans to address an even larger
potential market in the United States.
Evaluation of Renevia in ISO 10993 biocompatibility
studies has been successfully completed as prescribed by the
International Organization for Standardization for permanent implantable
medical devices. This testing is required by the United States Food and
Drug Administration and European Union regulatory authorities prior to
the initiation of clinical studies in humans. The results of these
preclinical studies successfully demonstrated the safety and
biocompatibility of Renevia .
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 is developing an integrated database
suite to complement GeneCards that will also
include the LifeMap Discovery database of embryonic development,
stem cell research and regenerative medicine, and MalaCards, the
human disease database. LifeMap will also market BioTime research
products. BioTime Acquisition Corporation ("BAC") is a subsidiary being
used to acquire the stem cell assets of Geron Corporation, including
patents and other intellectual property, biological materials, reagents
and equipment. 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.
Forward-Looking Statements
Statements pertaining to future financial and/or operating results,
future growth in research, technology, clinical development, and