• Data Reinforce Renevia’s Potential in
Multi-Billion Dollar Facial Aesthetics Market
• BioTime on Track to File for Renevia CE Mark
by End of 2017
• Conference Call Today with Lead Investigator
at 4:30 p.m. ET
BioTime, Inc. (NYSE MKT:BTX), a clinical-stage biotechnology
company developing and commercializing products addressing
degenerative diseases, today reported that, based on the analysis
of top line data, the Renevia® pivotal trial in Europe has met its
primary endpoint. The primary endpoint was the change in hemifacial
volume at six months in the treated patients compared to patients
in the delayed treatment arm as measured by 3D photographic
volumetric assessment. Treated patients received approximately 5cc
of Renevia in each side of the face (hemifacial). On average, 5.1cc
of hemifacial volume was measured after six months, which
represents an approximate 100% retention of transplanted volume.
Untreated patients had no incremental hemifacial volume after six
months. Comparison of the two trial arms had a statistical p value
<.001. All Renevia transplants were shown to be safe and well
tolerated. There were no serious adverse events during the
trial.
“In the Renevia pivotal trial, we studied patients with
HIV-associated facial lipoatrophy, which is a very severe form of
facial volume loss,” stated Adi Mohanty, Co-CEO of BioTime. “In
this clinical study, Renevia has proven to be safe and effective in
these patients. We believe the data announced today, positions us
to proceed with our planned CE mark filing.”
“There were further encouraging data at the 12-month time-points
for seven of the trial’s run-in patients, which followed the exact
same clinical trial protocol as enrolled patients, but were
considered training patients for the clinical sites,” continued Mr.
Mohanty. “This run-in group, on average, had 96% volume retention
at six months and 93% volume retention at 12 months, which suggests
the potential of even longer lasting volume retention in this
patient population. Additional data from the pivotal trial,
including 12-month performance and secondary endpoints, should be
received in the third quarter of 2017.”
“Renevia was used to enable the transfer of a patient’s own
autologous fat precursor cells as a means of possibly creating a
sustained volume. The retention of the transfer volume after six
months in patients is quite impressive and we look forward to
evaluating the 12-month data,” said Ramon Llull, MD, PhD, Director
of Stem Europe Mallorca Center, Mallorca, Spain and the primary
investigator of the Renevia trial. “Given the compromised tissue of
the patients participating in this study, I believe it is possible
that Renevia could perform even better in patients without HIV, and
I am beginning studies now with this larger population to test this
theory.”
About the Trial
The current Renevia Pivotal Trial was designed to demonstrate
the safety and efficacy of Renevia for treating facial lipoatrophy
(abnormal fat loss in the face) in HIV patients. The pivotal trial
was a multi-center, randomized, evaluator-blinded,
delayed-treatment-controlled study of the effectiveness and safety
of Renevia. Renevia was used to deliver the subject’s own
fat-derived cells harvested via liposuction and implanted under the
skin (subcutaneously) into areas of the patient’s face where there
has been a loss of fat (lipoatrophy).
The study enrolled nine run-in patients and an additional 47
patients have completed their six months follow up. Of these 47
trial patients, 26 were in the treated arm and 21 were in the
delayed treatment, control arm. The primary endpoint was the change
in hemifacial volume at six months in treated patients compared to
patients in the delayed treatment arm as measured by 3D
photographic volumetric assessment. Participants in the delayed
treatment group are being offered treatment after an evaluation at
six months.
Renevia Program Next Steps
The next steps for the Renevia program include submission of an
application for CE mark by the end of the year and conclusion of
partner selection to begin preparing for European commercial launch
next year. At the same time, BioTime will initiate additional pilot
trials studying various dosages of Renevia by itself, Renevia in
combination with autologous fat, and Renevia in combination with
stromal vascular fraction cells (SVF) for any facial volume loss.
Besides the studies mentioned by Dr. Llull, during the third
quarter, BioTime will support a U.S. investigator initiated study
by a leading plastic surgeon who will treat patients in need of
facial volume restoration without underlying HIV disease. These
patients will be treated with larger volumes of Renevia than in the
European pivotal trial in combination with their own fat precursor
cells obtained from a liposuction procedure. Successful results
from this as well as additional trials with Renevia would position
BioTime to quickly enter the global facial aesthetics market which
is estimated to be $7 billion annually.
“There are approximately 350,000 HIV patients in Europe
suffering from significant facial lipoatrophy and our objective is
to make Renevia available to these patients next year,” said Mr.
Mohanty. “If we achieve our goals, then we should be helping these
patients and generating revenue in 2018, while at the same time
working to expand Renevia’s addressable markets.”
Conference Call Information
BioTime is hosting a conference call and webcast
today, Wednesday, June 14, at 4:30 p.m. Eastern
Time / 1:30 p.m. Pacific Time to discuss the top
line data from the Company’s Renevia European pivotal trial. The
conference call dial-in number in the U.S./Canada is
1-877-407-0784. For international participants outside the
U.S./Canada, the dial-in number is 1-201-689-8560. For all callers,
please refer to the “BioTime, Inc. Conference Call.” The live
webcast can be accessed on the “Events & Presentations” page of
the “Investors & Media” section on the company’s website
at http://www.biotimeinc.com/.
A replay of the conference call will be available for seven
business days beginning about two hours after the conclusion of the
live call, by calling toll-free from U.S./Canada: 1-844-512-2921;
international callers dial 1-412-317-6671. Use the Conference ID
13664249. Additionally, the archived webcast will be available on
the “Events & Presentations” page of the “Investors &
Media” section on the company’s website
at http://www.biotimeinc.com/.
About Renevia®
Renevia is an investigational medical device that is being
developed as a replacement for whole adipose tissue in cell
assisted lipotransfer (CAL) procedures. Renevia’s hydrogel polymer
network provides the requisite amino acid sequences for adipose
stromal vascular cell attachment and may support proliferation,
localization and adipogenic differentiation. Renevia is part of the
HyStem hydrogel family of proprietary injectable matrices, which
are designed to facilitate the survival and growth of transplanted
cells. To learn more about Renevia, click here. To learn more about
the HyStem hydrogel technology, click here.
About BioTime, Inc.
BioTime, Inc. is a clinical-stage biotechnology company focused
on developing and commercializing novel therapies developed from
what the company believes to be the world’s premier collection of
pluripotent cell assets. The foundation of BioTime’s core
therapeutic technology platform is pluripotent cells that are
capable of becoming any of the cell types in the human body.
Pluripotent cells have potential application in many areas of
medicine with large unmet patient needs, including various
age-related degenerative diseases and degenerative conditions for
which there presently are no cures. Unlike pharmaceuticals that
require a molecular target, therapeutic strategies based on the use
of pluripotent cells are generally aimed at regenerating or
replacing affected cells and tissues, and therefore may have
broader applicability than pharmaceutical products. BioTime also
has significant equity holdings in two publicly traded companies,
Asterias Biotherapeutics, Inc. and OncoCyte Corporation, which
BioTime founded and which, until recently, were majority-owned
consolidated subsidiaries of BioTime.
BioTime common stock is traded on the NYSE MKT and TASE
under the symbol BTX. For more information, please
visit www.biotimeinc.com or connect with the company
on Twitter, LinkedIn, Facebook, YouTube,
and Google+.
To receive ongoing BioTime corporate communications, please
click on the following link to join the Company’s email alert list:
http://news.biotimeinc.com.
Forward-Looking Statements
Certain statements contained in this release are
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995. Statements pertaining to
future financial and/or operating results, future growth in
research, technology, clinical development, and potential
opportunities for BioTime, Inc. 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,
Inc. and its subsidiaries, particularly those mentioned in the
cautionary statements found in more detail in the “Risk Factors”
section of its Annual Reports on Form 10-K and Quarterly Reports on
Form 10-Q filed with the SEC (copies of which may be obtained at
www.sec.gov). Subsequent events and developments may cause these
forward-looking statements to change. BioTime specifically
disclaims any obligation or intention to update or revise these
forward-looking statements as a result of changed events or
circumstances that occur after the date of this release, except as
required by applicable law.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170614005361/en/
Investor Contact:EVC Group, Inc.Michael Polyviou,
646-445-4800mpolyviou@evcgroup.comDoug Sherk,
646-445-4800dsherk@evcgroup.comorMedia Contact:JQA Partners,
Inc.Jules Abraham, 917-885-7378jabraham@jqapartners.com
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