BioTime Reports Results of Clinical Safety Trial of Renevia™
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Renevia™ Appears Safe And Well Tolerated With No Serious
Unexpected Adverse Events Observed During The Trial Period
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Manufacturing and Biocompatibility Information Submitted in a Device
Master File to FDA
ALAMEDA, Calif.--(BUSINESS WIRE)--Jan. 13, 2014--
BioTime, Inc. (NYSE MKT: BTX) today announced the completion of a safety
trial evaluating Renevia™, a proprietary injectable matrix
designed to facilitate the stable engraftment of transplanted cells, and
the results of that study.
The ten healthy volunteers each received one subcutaneous injection of Renevia™
without cells (Renevia™-01 safety study). The primary
objective of the trial was to determine the safety and tolerability of Renevia™
as determined by post-treatment patient monitoring for adverse
reactions. Examinations of the subjects during the trial period have
shown that Renevia™ was well tolerated by all subjects with no
serious adverse events or subject withdrawals.
The Renevia™-01 safety study was completed on November 4,
2013 and a four week follow-up procedure evaluating the trial subjects
has been completed. The trial was conducted at The Stem Center (www.stem-center.com)
in Palma de Mallorca, Spain, located within the hospital Clinica USP
Palmaplanas in Palma. The Medical Director of the Center and the
Principal Investigator of this study is Dr. Ramon Llull, MD, PhD, a
leading expert on advanced regenerative therapies based on adipose cell
technology. A clinical study report is being drafted for submission to
the local ethics committee and Spanish National Regulatory Authorities.
The protocol for a pivotal clinical study (Renevia-02) is under
development and submission to Spanish regulatory authorities is planned
for the first quarter of 2014. This latter clinical study is intended 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, specifically
HIV-related facial lipoatrophy. Lipoatrophy is a localized loss of fat
beneath the skin and is often a consequence of the normal aging process,
but lipoatrophy can also be associated with trauma, surgery, and
specific diseases. For example, lipoatrophy is a frequent disorder
experienced by HIV patients being treated with antiviral 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. The Renevia-02 study
will be conducted at The Stem Center in Mallorca with Dr. Ramon Llull as
its principal investigator. BioTime’s plans to proceed with the Renevia-02
pivotal clinical trial 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. BioTime has submitted a Device Master
File (called an MAF) to the United States Food and Drug Administration
with the details of the manufacturing, testing, and biocompatibility of
the HyStem® hydrogels, of which Renevia™
is one version. The MAF was filed in order to allow the FDA to easily
access the manufacturing and biocompatibility information to support any
future clinical studies that third party investigators may elect to
initiate for their cell or drug products utilizing HyStem®
hydrogels.
About Renevia™
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,
and Australia. A video
of Dr. William Tew discussing HyStem® product
development is available on BioTime’s website.
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:
• Asterias Biotherapeutics, Inc. is a new subsidiary which has 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 regenerative medicine.
• OncoCyte Corporation is developing products and technologies to
diagnose and treat cancer.
• Cell Cure Neurosciences Ltd. (“Cell Cure Neurosciences”) is an
Israel-based biotechnology company focused on developing stem cell-based
therapies for retinal and neurological disorders, including the
development of retinal pigment epithelial cells for the treatment of
macular degeneration, and treatments for multiple sclerosis.
• LifeMap Sciences, Inc. (“LifeMap Sciences”) 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.
• ES Cell International Pte Ltd., a Singapore private limited company,
developed clinical and research grade hES cell lines and may plans to
market those cell lines and other BioTime research products in over-seas
markets as part of BioTime’s ESI BIO Division.
• 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 cardiovascular and related ischemic disorders, as well as products
for research using cell reprogramming technology.
To receive ongoing BioTime corporate communications, please click on the
following link to join our email alert list: http://news.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.
To receive ongoing BioTime corporate communications, please click on the
following link to join our email alert list: http://news.biotimeinc.com.
Source: BioTime, Inc.
BioTime, Inc.
Lesley Stolz, PhD, 510-521-3390, ext 367
Executive
Vice President, Corporate Development
lstolz@biotimemail.com
or
Judith
Segall, 510-521-3390, ext 301
jsegall@biotimemail.com
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