BioTime Reports Interim Results on Renevia™ Clinical Safety Trial
- Enrollment completed in first safety study of Renevia™ for
dermatological applications -
- Two weeks following administration, Renevia™ appears safe
and well tolerated with no serious unexpected adverse events observed to
ALAMEDA, Calif.--(BUSINESS WIRE)--Oct. 28, 2013--
BioTime, Inc. (NYSE MKT: BTX), today announced that William Tew, Ph.D.,
BioTime’s Chief Commercial Officer will provide an update on the
development of Renevia™ at an investor meeting in New York City.
In his presentation, Dr. Tew will announce that enrollment in a safety
trial evaluating Renevia™, a proprietary injectable matrix
designed to facilitate the stable engraftment of transplanted cells, is
The ten healthy volunteers each received one subcutaneous injection of Renevia™
without cells. The primary objective of the trial is to determine the
safety, tolerability, and acceptance of Renevia™ without
cells as determined by monitoring subjects for any post-treatment
reactions. Examinations of the subjects after they received Renevia™
injections have shown that Renevia™ was well-tolerated by all
subjects with no serious adverse events or subject withdrawals. A final
check of the enrolled subjects for adverse events will be made four
weeks after the injection.
The Renevia™ safety study was initiated on October 7, 2013 at The
Stem Center (www.stem-center.com)
in Palma de Mallorca, Spain, an innovative patient therapy center,
laboratory, and professional research facility located within the
world-class hospital Clinica USP Palmaplanas in Palma. The Medical
Director of the Center is Dr. Ramon Lull, MD, PhD, a leading expert on
advanced regenerative therapies based on adipose technology. The Stem
Center is owned and operated by the GID Group, Inc., Louisville, CO, USA.
Subsequent clinical studies are planned to document the efficacy of Renevia™
as a delivery matrix for adipose cells to restore normal skin contours
in patients where the subcutaneous adipose tissue has been lost to
lipoatrophy, beginning with HIV related facial lipoatrophy. Lipoatrophy
is a localized loss of fat beneath the skin. Lipoatrophy is often a
consequence of the normal aging process where the loss of fat in the
cheeks or the back of the hands contributes to an aged appearance, but
lipoatrophy can also be associated with trauma, surgery, and diseases,
and is frequently suffered by HIV patients being treated with anti-viral
drugs. According to published estimates, at least several hundred
thousand patients in Europe, and a similar number in the U.S., are
affected by lipoatrophy and related conditions such as lipodystrophy.
These patients have very limited treatment options and these conditions
therefore represent a significant unmet medical need. BioTime’s plans to
proceed with additional clinical trials are subject to obtaining
required regulatory and institutional approvals.
Renevia™ is manufactured in the US in compliance with cGMP
requirements and has been tested pursuant to ISO 10993 standards for
implantable medical devices and shown to be biocompatible without
adverse effects in animal studies.
Renevia™ is a member of BioTime’s HyStem®
family of hydrogels. These unique biomaterials are designed as matrices
and scaffolds for tissue engineering and regenerative medicine
applications. HyStem® hydrogels are distributed
and sold worldwide by BioTime and its distributors for pre-clinical
research. Clinical grade hydrogels are also available to support
translational research and investigator initiated clinical studies.
BioTime’s HyStem® technology is covered by two
issued US patents with applications pending in the EU, Canada, Japan,
About BioTime, Inc.
BioTime is a biotechnology company engaged in research and product
development in the field of regenerative medicine. Regenerative medicine
refers to therapies based on stem cell technology that are designed to
rebuild cell and tissue function lost due to degenerative disease or
injury. BioTime’s focus is on pluripotent stem cell technology based on
human embryonic stem (“hES”) cells and induced pluripotent stem (“iPS”)
cells. hES and iPS cells provide a means of manufacturing every cell
type in the human body and therefore show considerable promise for the
development of a number of new therapeutic products. BioTime’s
therapeutic and research products include a wide array of proprietary PureStem™
progenitors, HyStem® hydrogels, culture media, and
differentiation kits. BioTime is developing Renevia™ (a HyStem®
product) as a biocompatible, implantable hyaluronan and collagen-based
matrix for cell delivery in human clinical applications. In addition,
BioTime has developed Hextend®, a blood
plasma volume expander for use in surgery, emergency trauma treatment
and other applications. Hextend® is manufactured and
distributed in the U.S. by Hospira, Inc. and in South Korea by CJ
CheilJedang Corporation under exclusive licensing agreements.
BioTime is also developing stem cell and other products for research,
therapeutic, and diagnostic use through its subsidiaries:
OncoCyte Corporation is developing products and technologies to
diagnose and treat cancer.
ES Cell International Pte Ltd., a Singapore private limited company,
develops hES products for research use.
BioTime Asia, Limited, a Hong Kong company, may offer and sell
products for research use for BioTime’s ESI BIO Division.
OrthoCyte Corporation is developing therapies to treat orthopedic
disorders, diseases and injuries.
ReCyte Therapeutics, Inc. is developing therapies to treat a variety
of blood and lymphatic vascular disorders, as well as products for
research using iPS and other cell reprogramming technology.
Cell Cure Neurosciences Ltd. is an Israel-based biotechnology company
focused on developing stem cell-based therapies for retinal and
neurological degenerative diseases. Its lead product is OpRegen®
for the treatment of macular degeneration.
LifeMap Sciences, Inc. markets, sells and distributes 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..
Asterias Biotherapeutics, Inc. is a new subsidiary that recently
acquired 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
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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Source: BioTime, Inc.
Lesley Stolz, PhD, 510-521-3390, ext 367
Vice President, Corporate Development
Segall, 510-521-3390, ext 301