ALAMEDA, Calif.--(BUSINESS WIRE)--Jan. 22, 2018--
BioTime, Inc. (NYSE American: BTX), a late-stage, clinical biotechnology
company developing and commercializing products addressing degenerative
diseases, today announced its 2018 clinical and corporate milestone
BioTime will continue to focus on the core pillars of its stated
strategy of Clinical Progress, Simplification and Unlocking Value for
Projected 2018 Renevia® Milestones
BioTime expects to submit Renevia® for CE mark in Europe
during the first quarter, with approval expected later this year.
The Company intends to begin enrollment of a European study of Renevia®
in facial aesthetics for a broader population.
The Company expects to meet with the FDA to confirm the U.S. approval
pathway of Renevia® for facial aesthetics.
BioTime plans to submit an Investigational Plan to the FDA for a
registrational U.S. facial aesthetics trial.
BioTime plans to begin enrollment of a registrational U.S. facial
Clinical data from the European pivotal trial is expected to be
presented at the International Master Course on Aging Sciences (IMCAS)
in the first quarter of 2018.
The Company expects to share data from other Renevia®/Premvia®
Projected 2018 OpRegen® Milestones
BioTime anticipates approval from the DSMB and to begin enrollment of
The Company expects to open more U.S. sites to include the growing
number of interested Retinal surgeons in the current clinical study.
If accepted, BioTime is planning on presenting clinical data from the
first 3 Cohorts at the Association for Research in Vision and
Ophthalmology (ARVO) conference in the second quarter of 2018.
The Company expects to present preliminary functional data from
patients treated in the ongoing trial later this year.
If accepted, detailed data from first 3 cohorts and available data
from the fourth Cohort will be presented at the American Academy of
Ophthalmology (AAO) conference in the fourth quarter of 2018.
Projected 2018 Corporate Milestones
BioTime will advance its strategy of simplification by unlocking value
of certain of its programs addressing the emerging field of
interventional gerontology for its shareholders, with the expected
distribution of some or all of its holdings in AgeX Therapeutics to
The funds raised by BioTime and its subsidiary, AgeX, towards the end of
last year provide both BioTime and AgeX sufficient capital, at their
currently planned spending levels, to fund their respective operations
well into 2019.
Renevia® is an investigational medical device that is being
developed as an alternative for whole adipose tissue transfer (fat
grafting) procedures. Renevia’s® hydrogel polymer network
provides the requisite substrate 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.
OpRegen®, which is being studied for the treatment of the dry
form of AMD, consists of a suspension of Retinal Pigment Epithelial
(RPE) cells that are delivered subretinally during a simple intraocular
injection. RPE cells are essential components of the back lining of the
retina, and function to help nourish the retina including
photoreceptors. A proprietary process that drives the differentiation of
human pluripotent stem cells is used to generate high purity OpRegen® RPE
cells. OpRegen® RPE cells are also “xeno-free," meaning that
no animal products are used at any point in the derivation and
production process. The avoidance of the use of animal products
eliminates some potential safety concerns. Preclinical studies in rats
have shown that following a single subretinal injection of OpRegen®,
the cells can rapidly organize into its natural monolayer structure in
the subretinal space and survive throughout the lifetime of the animal.
OpRegen® is designed to be an “off-the-shelf” allogeneic
(non-patient specific) product. Unlike treatments that require multiple,
frequent injections into the eye, it is expected that OpRegen® would
be administered in a single procedure. OpRegen® was granted
Fast Track designation from the FDA, which allows more frequent
interactions with the agency, and eligibility for accelerated approval
and priority review. OpRegen® is a registered trademark
of Cell Cure Neurosciences Ltd., a majority-owned subsidiary of BioTime,
About BioTime, Inc.
BioTime is a late-stage clinical biotechnology company focused on
developing and commercializing products addressing degenerative
diseases. The Company’s current clinical programs are targeting three
primary sectors, aesthetics, ophthalmology and cell and drug delivery.
Its clinical programs are based on two platform technologies:
pluripotent cells, which can become any type of cell in the human body,
and cell/drug delivery. Renevia®, a cell delivery product,
met its primary endpoint in an EU pivotal clinical trial for the
treatment of facial lipoatrophy in HIV patients earlier this year.
Submission for approval of Renevia® in the EU is expected to
be early 2018, with possible approval and commercial launch in 2018.
There were no device related serious adverse events reported to date.
OpRegen®, a retinal pigment epithelium transplant therapy, is
in a Phase I/IIa multicenter trial for the treatment of dry age-related
macular degeneration, the leading cause of blindness in developing
countries. There were no related serious adverse events reported to
date. BioTime also has significant equity holdings in two publicly
traded companies, Asterias Biotherapeutics, Inc. (NYSE American: AST)
and OncoCyte Corporation (NYSE American: OCX), and a private
company, AgeX Therapeutics, Inc.
BioTime common stock is traded on the NYSE American and TASE under the
symbol BTX. For more information, please visit www.biotime.com or
connect with the company on Twitter, LinkedIn, Facebook, YouTube,
To receive ongoing BioTime corporate communications, please click on the
following link to join the Company’s email alert list: http://news.biotime.com.
About AgeX Therapeutics
AgeX Therapeutics, Inc., a subsidiary of BioTime, Inc. (NYSE American:
BTX), is a biotechnology company applying technology relating to
cellular immortality and regenerative biology to aging and age-related
diseases. The company has three initial areas of product development:
pluripotent stem cell-derived brown adipocytes (AGEX-BAT1); vascular
progenitors (AGEX-VASC1); and induced Tissue Regeneration (iTR). Initial
planned indications for these products are Type 2 diabetes, cardiac
ischemia, and tissue regeneration respectively. For more information,
please visit www.agexinc.com
or connect with the company on Twitter or Facebook.
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 product technology,
clinical development, regulatory approval timelines, the success of
potential cosmetic applications 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 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/20180122005740/en/
Source: BioTime, Inc.
David Nakasone, 510-871-4188
JQA Partners, Inc.
Jules Abraham, 917-885-7378