Positive Early Data From BioTime’s Renevia Pivotal Trial Presented at IFATS Meeting
November 18 2016 - 3:00AM
Business Wire
-3D-imaging Suggests Grafts Retained Volume
Over the Assessment Period-
-Cells Remained Viable and Proliferated in
Renevia Hydrogel-
BioTime, Inc. (NYSE MKT: BTX), a clinical-stage
biotechnology company with a focus on pluripotent cell-based
technologies, announced details of positive data from its Renevia®
pivotal trial, reported via a presentation at the 14th annual
International Federation for Adipose Therapeutics and Science
meeting (IFATS) on Thursday, November 17, in San Diego. The
presentation was based on data from the “run-in,” testing sample
subjects to the European pivotal trial.
The presentation, titled “Stromal Cell-Hydrogel Construct
Possibly Generates Clinically Relevant Neo-Tissue In Facial
HIV-Lipoatrophy Pivotal Multicenter Clinical Trial: Early Analysis
On Testing Patient Sample,” was given by Ramon Llull, M.D., Ph.D.,
director of the Stem Europe Mallorca Center, in Spain, and the
principal investigator of the trial.
Highlights of the presentation included:
- Adipose progenitor cells (fat cells)
obtained from a liposuction aspirate remained viable and were
observed to proliferate when combined with the Renevia
hydrogel
- The Renevia gel and progenitor cells
were successfully administered in the run-in subjects with no
serious adverse events
- 3D-image analysis suggests that the
grafts retained volume over the assessment period, and the treating
physician-observed incremental volume was retained in select
patients who had progressed to the one-year follow-up
evaluation
“We are encouraged that the administration of Renevia worked
well in these patients,” commented Dr. Llull. “Existing methods
used to address HIV and age-related facial volume loss provide only
temporary solutions. We are seeing signs indicating that Renevia
may be able to generate new facial tissue which could result in
more natural, longer-lasting outcomes.”
Developed as an alternative for whole adipose tissue fat
transfer procedures, Renevia is designed to mimic the
naturally-occuring extracellular matrix and provide a 3-D scaffold
that enables effective cell transplant and engraftment. In the
run-in portion of this trial, the Renevia administration procedure
was found to be reproducible, and the pivotal trial is now into its
controlled phase. Encouraging signs of Renevia being able to
promote new tissue generation were seen with the run-in practice
patients. If the pivotal trial is successful, the company plans to
file the data as the basis for the issuance of CE marking for
European use. CE marking is anticipated as early as the second half
of 2017.
About BioTime
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.
In addition to the development of therapeutics, BioTime’s
research and other activities have resulted, over time, in the
creation of other subsidiaries that address other non-therapeutic
market opportunities such as cancer diagnostics, drug development
and cell research products, and mobile health software
applications.
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+.
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, Inc. 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.
To receive ongoing BioTime corporate communications, please
click on the following link to join our email alert list:
http://news.biotimeinc.com.
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version on businesswire.com: http://www.businesswire.com/news/home/20161118005162/en/
Investor Contact:EVC Group, Inc.Matt Haines,
917-733-9297mhaines@evcgroup.comorMedia Contact:Gotham
Communications, LLCBill Douglass,
646-504-0890bill@gothamcomm.com
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