Full Press Release Details
Reports Interim Results on Renevia
Clinical Safety Trial
Enrollment completed in first safety study of Renevia
for dermatological applications -
weeks following administration, Renevia
appears safe and well tolerated with no serious unexpected adverse
events observed to date -
ALAMEDA, Calif.--(BUSINESS WIRE)--October 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 complete.
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, and Australia.
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