Full Press Release Details
Reports Results of Clinical Safety Trial of Renevia
Appears Safe And Well Tolerated With No Serious Unexpected Adverse
Events Observed During The Trial Period
and Biocompatibility Information Submitted in a Device Master File to
ALAMEDA, Calif.--(BUSINESS WIRE)--January 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
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
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.
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