BioTime Submits Protocol for Initiation of Human Clinical Trials of Renevia™ in Europe
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™.
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 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
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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