BioTime, Inc. (NYSE MKT: BTX) today announced that the first patient was
successfully treated in the Company’s pivotal clinical trial in Europe
assessing the efficacy of Renevia™ for the treatment of
HIV-associated lipoatrophy. HIV-associated lipoatrophy is a disorder
characterized by abnormal loss of body fat from under the skin that
occurs in almost half of the approximately three million people on
anti-retroviral therapy in the U.S. and Europe. Renevia is a
proprietary injectable matrix designed to facilitate the stable
engraftment of transplanted cells. The uniqueness of Renevia is that it
allows the mixture of cells with the matrix in a liquid form such that
the cells and matrix can be injected easily and safely through a small
gauge syringe, and then the matrix can polymerize around the cells to
create a three-dimensional tissue within the body.
In the trial, Renevia is being tested as a delivery matrix for
the patient’s own fat-derived cells and injected into portions of the
patient’s face where there is facial lipoatrophy in order to promote
facial tissue reconstruction. The first treatment marks the beginning of
enrollment for this pivotal trial and follows the previous successful
safety trial of Renevia, the completion of which was announced in
2014. The procedure was performed at The Stem Center in Palma de
Mallorca, Spain, an innovative patient therapy center and a global
leader in clinical research aimed at the use of a patient’s adipose
derived stem cells for cosmetic and regenerative therapies. The clinical
site is located within the Clinica USP Palma Planas hospital in Palma.
“The current options for patients with facial lipoatrophy do not provide
a natural long lasting result, so I am excited to be leading this
important clinical trial to bring Renevia to this community,”
said Ramon Llull, MD, PhD, Medical Director of The Stem Center and
Principal Investigator for the Renevia studies. Dr. Llull is a
leading expert on advanced regenerative therapies based on lipotransfer.
“The first subject treated in our Renevia pivotal trial is a
significant clinical milestone for an important BioTime pipeline
product,” said Adi Mohanty, BioTime’s Chief Operating Officer. “Renevia
is based on our proprietary HyStem® technology
platform for cell and molecule transfer, and has the potential to be the
first CE-marked injectable delivery vehicle for safe transplantation of
therapeutic cells. We are optimistic about the promise of this
technology platform because of the potential to solve a major hurdle in
the development of effective cell transplant therapies. We believe that
meeting the endpoint in our Renevia pivotal trial could lead to
submission for CE Mark approval in 2016 for HIV related facial
lipoatrophy, and could pave the way for other future applications in
transplanting other types of cells to address unmet medical needs.”
On November 4, 2014, the Spanish Agency of Medicines and Health Products
(“AEMPS”) authorized BioTime to conduct a randomized, evaluator-blinded,
delayed-treatment-controlled study of the effectiveness and safety of Renevia
as a resorbable matrix for the delivery of autologous adipose-derived
cells to treat subcutaneous facial lipoatrophy defects associated with
antiviral therapy for HIV infection. The pivotal study will include a
minimum of 56 and up to 92 HIV positive males and females between 18-65
years of age. Subjects will be randomized with half in the treatment
group and half in a delayed-treatment cohort, each receiving a single
treatment procedure of Renevia™ with autologous adipose cells
harvested by liposuction and implanted in the mid-facial region. The
primary effectiveness measure will be the comparison of the change in
skin thickness between the treatment and delayed treatment groups. A
secondary endpoint will be mid-face volume deficit and global aesthetic
improvement scores. Patients will be monitored at one, three, and
six-month intervals after treatment. Additional information on the trial
will be made available on BioTime’s website at www.biotimeinc.com.
About Facial Lipoatrophy and HIV-related Facial Lipoatrophy
Facial lipoatrophy is the loss of facial fat tissue, which is a key
component for an overall youthful facial appearance. Facial lipoatrophy
is an unfortunate, but inevitable, condition that typically develops as
we age but is dramatically accelerated in those HIV-infected individuals
being treated with antiretroviral therapy (ART). Indeed the loss of
facial fat can be nearly complete in these individuals on ART.
In HIV-infected patients on antiretroviral therapy (ART) facial
lipoatrophy is common and particularly devastating. The resulting facial
wasting ages the individual’s appearance prematurely and, along with a
thinning of the skin, allows musculature and vasculature to be easily
seen, resulting in what is commonly known as “the face of AIDS.”
Treatment of the condition has been determined to be medically advisable
to improve the individual’s self-esteem and quality of life.
Because ART has greatly increased long term survival in HIV-positive
patients the incidence of associated lipoatrophy has risen dramatically.
According to statistics published by AVERT (www.avert.org),
worldwide there were 34 million people living with HIV/AIDS in 2011.
According to the World Health Organization (WHO) 10 million of these are
receiving ART. That number is expected to grow to 15 million people by
the end of 2015.
HyStem®
Technology and Renevia™
BioTime’s HyStem® hydrogels, including Renevia,
are a family of unique and proprietary biomaterials that are designed to
function as adhesion matrices for the stable attachment and survival of
cells. The failure rate in many applications of cell grafts without such
a matrix is high because of difficulties in achieving cell attachment
and survival. The achievement of high success rates for cell grafts
would create opportunities to develop cell therapies for many high unmet
medical needs. A unique feature of the proprietary technology is that it
allows the mixture of cells with the matrix in a liquid form such that
the cells and matrix can be injected easily and safely through a small
gauge syringe, and then the matrix can polymerize around the cells to
create a three-dimensional tissue within the body. The matrix is then
resorbed by the body over a few months. HyStem hydrogels are
currently sold worldwide by BioTime and its distributors for
pre-clinical research for a wide array of applications in regenerative
medicine including the engraftment of cells in the brain, liver,
cartilage and bone, heart, and vocal cords. Premvia™, a HyStem
based hydrogel, is a recently FDA-cleared medical device indicated for
the management of wounds. BioTime’s HyStem technology is covered
by two issued US patents with applications pending in the EU, Canada,
Japan, and Australia.
About BioTime
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. Renevia™
(a HyStem product), is now in a pivotal trial in Europe as a
biocompatible, implantable hyaluronan and collagen-based matrix for cell
delivery in the treatment of HIV-related lipoatrophy. 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
HealthCare Corporation, under exclusive licensing agreements.
BioTime is also developing stem cell and other products for research,
therapeutic, and diagnostic use through its subsidiaries:
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Asterias
Biotherapeutics, Inc. is developing pluripotent stem-cell based
therapies in neurology and oncology, including AST-OPC1
oligodendrocyte progenitor cells in spinal cord injury, multiple
sclerosis and stroke, and AST-VAC2, an allogeneic dendritic cell-based
cancer vaccine. Asterias Series A common stock is traded on the NYSE
MKT under the symbol AST.
-
BioTime Asia, Ltd., a Hong Kong company, may offer and sell products
for research use for BioTime’s ESI BIO Division.
-
Cell
Cure Neurosciences Ltd. is an Israel-based biotechnology company
focused on developing stem cell-based therapies for retinal and
neurological disorders. OpRegen® is currently
in a Phase I/IIa clinical trial for the treatment of the dry-form of
age-related macular degeneration.
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ESI
BIO is the research and product marketing division of BioTime,
providing stem cell researchers with products and technologies to
enable them to translate their work into the clinic, including PureStem®
progenitors and HyStem® hydrogels.
-
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.
-
LifeMap
Solutions, Inc. is a subsidiary of LifeMap Sciences focused on
developing mobile health (mHealth) products.
-
OncoCyte
Corporation is developing products and technologies to diagnose and
treat cancer, including PanC-Dx™, with four clinical studies
currently underway.
-
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.
BioTime common stock is traded on the NYSE MKT under the symbol BTX. For
more information, please visit www.biotimeinc.com
or connect with the company on Twitter,
LinkedIn,
Facebook,
YouTube,
and Google+.
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.
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Copyright Business Wire 2015