Full Press Release Details
Receives Authorization to Begin Pivotal Human Clinical Trial of Renevia
to be utilized in the treatment of HIV-related lipoatrophy, a disorder
estimated to afflict more than 3.5 million patients globally
enrollment initiated; expected to be completed in 2015
ALAMEDA, Calif.--(BUSINESS WIRE)--November 4, 2014--BioTime, Inc. (NYSE
MKT:BTX) today reported that it has received authorization to begin its
pivotal human clinical trial of Renevia in Europe. In the
trial, Renevia will be used in combination with the patient's own
fat-derived cells and injected into portions of the patient's face where
there has been a loss of fat from under the skin (lipoatrophy).
Lipoatrophy is estimated to occur in 35-50% of the 10 million HIV
patients on antiretroviral therapy. This pivotal trial follows the
previous successful safety trial of Renevia, the completion of
which was announced earlier in 2014.
"Renevia has the potential to be the first approved product
that allows cells to be easily transplanted through a syringe and then
safely polymerized into three-dimensional tissue constructs within the
human body," said William Tew, Ph.D., BioTime's Chief Commercial
Officer. "We are excited to enter this last phase of clinical trials for Renevia
as well as by the promise of this technology for the transplantation of
other types of cells to address unmet medical needs. BioTime considers Renevia
a key strategic asset for its future regenerative medicine programs
which are focused on the development of human embryonic stem
cell-derived brown adipocytes, vascular, and osteochondral cells to
treat tissues afflicted with degenerative disease. If the pivotal trial
meets its primary end points, then we would expect to submit Renevia
for CE Mark approval in 2016."
About the Renevia Clinical Trial
The Spanish Agency of Medicines and Medical Devices (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 arising from HIV
infection. The 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 course 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.
Patient enrollment, which has begun, is expected to be completed in
2015. Additional information on the trial will be made available on
BioTime's website at www.biotimeinc.com.
The trial 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 Llull, MD,
PhD, is a leading expert on advanced regenerative therapies based on
About Facial Lipoatrophy
Facial lipoatrophy is a condition characterized by localized loss of fat
under the skin. It is common in HIV-infected patients on antiretroviral
therapy (ART), and 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.
While the use of highly active ART in the treatment of HIV-positive
patients has greatly increased longevity, the reported incidence of
HIV-associated lipoatrophy has correspondingly risen. According to
statistics published by AVERT (www.avert.org), worldwide there
were 34 million people living with HIV/AIDS in 2011 with 900,000 of
these in western and central Europe and 1.4 million in North America.
UNICEF, UNAIDS, and the World Health Organization (WHO) reported in 2013
that the number of people receiving ART has tripled in five years to
approximately 10 million people. A substantial effort is underway to
reach a global target of 15 million people receiving ART by the end of
At present, commonly-used products for the treatment of HIV-related
lipoatrophy include dermal fillers or products that trigger fibrotic
reactions which create fibrous tissue that has an effect of bulking the
skin, but not a restoration of natural subcutaneous fat with its
associated texture and appearance. A full course of treatment of those
products can require multiple injections over a period of several
months. BioTime expects that a single treatment of Renevia with
adipose-derived cells when injected with a small gauge cannula will
result in a reconstitution of normal subcutaneous fat and restoration of
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. 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,TM
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