Full Press Release Details
Receives Approval to Begin Human Clinical Trials of Renevia
ALAMEDA, Calif.--(BUSINESS WIRE)--August 28, 2013--BioTime, Inc. (NYSE
MKT: BTX) today announced that it has received approval from The Spanish
Agency of Medicines and Medical Devices (AEMPS) to begin human clinical
trials of Renevia , a unique biomaterial used as a delivery
matrix for autologous adipose derived cells to treat the loss of
subcutaneous adipose tissue (lipoatrophies) arising from trauma,
surgical resection, and congenital defects and disease. This AEMPS
approval follows the earlier approval this year from the Balearic Island
Ethics Committee Approval for the first of a multiphase clinical
investigation of Renevia .
The clinical studies will be conducted at The Stem Center in Palma de
Mallorca, Spain, an innovative patient therapy center, laboratory, and
professional research facility located within the Clinica USP Palma
Planas hospital in Palma. The Medical Director of The Stem Center and
Principal Investigator for the Renevia studies, Ramon Lull, MD,
PhD, is 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.
BioTime expects that the first clinical investigation, a study in 10
volunteers to demonstrate the safety of Renevia in humans,
will be completed before the end of the year. Subsequent clinical
studies are being planned to document the efficacy of Renevia
as a delivery matrix for autologous adipose cells to restore normal skin
contours in patients where the subcutaneous adipose tissue had been lost
to lipoatrophy. Commenting on the approval, Dr. Lull, said, "The desire
for a new and effective delivery matrix allowing for easier placement
and potentially superior grafting of autologous cells is high. We are
looking forward to getting started testing this novel biomaterial." Renevia
is manufactured in the US in compliance with cGMP requirements and has
been tested pursuant to ISO 10993 standards for Class III implantable
medical devices. In these studies Renevia has been shown
to be biocompatible.
Commenting on the AEMPS approval to begin clinical investigations,
William, P. Tew, PhD, BioTime's Chief Commercial Officer, said "We are
delighted to begin this next phase in our program for obtaining a CE
Mark for Renevia . We have developed Renevia to
provide plastic and reconstructive surgeons a safe and effective
delivery matrix for tissue engineering and regenerative medicine
applications utilizing autologous adipose cells."
Renevia is a member of BioTime's HyStem
family of hydrogels. These unique biomaterials are designed as matrices
and scaffolds for cell delivery in a wide variety of medicine
applications. HyStem hydrogels are distributed
and sold worldwide by BioTime and its distributors for pre-clinical
research. 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.
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, 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. LifeMap Sciences also markets BioTime research products and PanDaTox,
an innovative, recently developed, searchable database that can aid in
the discovery of new antibiotics and biotechnologically beneficial
Asterias Biotherapeutics, Inc. is a new subsidiary being used to
acquire 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.
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