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BioTime Announces First Patient Treated in Pivotal Clinical Trial of Renevia for HIV-Associated Lipoatrophy ALAMEDA, Calif.--(BUSINESS WIRE)

Key Takeaway: Announces First Patient Treated in Pivotal Clinical Trial of Renevia for HIV-Associated Lipoatrophy ALAMEDA, Calif.--(BUSINESS WIRE)--February 24, 2015--BioTime, Inc. (NYSE MKT: BTX) today announced that the first patient was successfully treated in the Company's pivotal clin

Full Press Release Details

Announces First Patient Treated in Pivotal Clinical Trial of Renevia
for HIV-Associated Lipoatrophy
ALAMEDA, Calif.--(BUSINESS WIRE)--February 24, 2015--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
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
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
Last updated: Feb 24, 2015