BioTime’s Subsidiary Cell Cure Neurosciences Ltd. Receives FDA Fast-Track Designation for OpRegen® for the Treatment of the Dry Form of Age-Related Macular Degeneration

ALAMEDA, Calif. & JERUSALEM–(BUSINESS WIRE)–BioTime, Inc. (NYSE MKT and TASE: BTX) and its subsidiary Cell Cure
Neurosciences Ltd. (“Cell Cure”) today announced that the U.S. Food and
Drug Administration (“FDA”) has granted Fast Track designation for OpRegen®,
a cell-based therapeutic product consisting of retinal pigment
epithelial (RPE) cells designed to block the progression of the severe
dry-form of age-related macular degeneration (AMD), a leading cause of
blindness in an aging population.

Under an Investigational New Drug Application (IND) for “Retinal Pigment
Epithelium (RPE) Cells derived from Allogenic Human Embryonic Stem
Cells; Transplanted Subretinally” and after receiving approval from the
Israel Ministry of Health, Cell Cure is now enrolling patients
at Hadassah University Medical Center in Jerusalem, Israel, in a
clinical Phase I/IIa dose-escalation study evaluating the safety and
efficacy of OpRegen® for geographic atrophy (GA), the severe
stage of the dry form of age-related macular degeneration (dry-AMD). The
first patient was treated earlier this year and Cell Cure expects to
provide interim data in early 2016.

The FDA grants Fast Track designation if it determines that a drug fills
an unmet medical need in a serious condition. According to the FDA, a
drug that receives Fast Track designation is eligible for some or
all of the following:

  • More frequent meetings with FDA to discuss the drug’s development plan
    and ensure collection of appropriate data needed to support drug
    approval;
  • More frequent written communication from FDA about such things as the
    design of the proposed clinical trials and use of biomarkers;
  • Eligibility for Accelerated Approval and Priority Review, if relevant
    criteria are met; and
  • Rolling Review, which means that a drug company can submit completed
    sections of its Biologic License Application (BLA) or New Drug
    Application (NDA) for review by FDA, rather than waiting until every
    section of the NDA is completed before the entire application can be
    reviewed. BLA or NDA review usually does not begin until the drug
    company has submitted the entire application to the FDA.

Additional information about the FDA Fast Track Designation can be found
on the FDA’s website at www.fda.gov.

About Dry Age-Related Macular Degeneration (Dry–AMD)

Dry AMD is the most common type of macular degeneration and affects
approximately 90% of people with the disorder. In the dry form, there is
a loss or dysfunction of the layer of retinal pigment epithelial (RPE)
cells, generally in the region of the eye called the macula. These RPE
cells support the light detecting photoreceptor cells that are so
critical to vision. When we look at something, the photoreceptors (rods
and cones) detect the light and send the information to the brain
allowing us to perceive our surroundings. The age-dependent loss of the
RPE cells therefore leads to degeneration of nearby photoreceptors and
this can lead to severe vision loss or even blindness. Generally, the
damage caused by the “dry” form is not as severe or rapid as that of the
“wet” form. However, over time, it can cause profound vision loss. The
more advanced stage of dry macular degeneration is called geographic
atrophy. While there are therapeutics available to treat the wet form of
AMD, there are currently no FDA-approved therapies for dry-AMD.

About Cell Cure Neurosciences Ltd.

Cell Cure Neurosciences Ltd. was established in 2005 as a subsidiary
of ES Cell International Pte. Ltd. (ESI), now a subsidiary of BioTime,
Inc. Cell Cure is located in Jerusalem, Israel on the campus of Hadassah
University Hospital. Cell Cure’s mission is to become a leading supplier
of human embryonic stem cell-based therapies for the treatment of
retinal and neural degenerative diseases. Its technology platform is
based on the manufacture of diverse cell products sourced from
clinical-grade (GMP) human embryonic stem cells. Its current focus is
the development of retinal pigment epithelial (RPE) cells for the
treatment of age-related macular degeneration. Cell Cure’s major
shareholders include BioTime, Inc., Hadasit BioHoldings Ltd. (Tel Aviv
Stock Exchange: HDST), and Teva Pharmaceuticals Industries Ltd. (NYSE:
TEVA). Additional information about Cell Cure can be found on the web at www.cellcureneurosciences.com.

About BioTime

BioTime, Inc., a pioneer in regenerative medicine, is a clinical-stage
biotechnology company. BioTime and its subsidiaries are leveraging their
industry-leading experience in pluripotent stem cell technology and a
broad intellectual property portfolio to facilitate the development and
use of cell-based therapies and gene marker-based molecular diagnostics
for major diseases and degenerative conditions for which there presently
are no cures. The lead clinical programs of BioTime and its subsidiaries
include OpRegen®, currently in a Phase I/IIa
trial for the treatment of the dry form of age-related macular
degeneration; AST-OPC1, currently in a Phase I/IIa trial for
spinal cord injuries; Renevia™, currently in a pivotal trial
in Europe as an injectable matrix for the engraftment of transplanted
cells to treat HIV-related lipoatrophy; and cancer diagnostics, nearing
the completion of initial clinical studies for the detection of lung,
bladder, and breast cancers. AST-VAC2, a cancer vaccine, is
in the pre-clinical trial stage.

BioTime’s subsidiaries include the publicly traded Asterias
Biotherapeutics, Inc. (NYSE MKT: AST), developing pluripotent stem
cell-based therapies in neurology and oncology, including AST-OPC1 and AST-VAC2; Cell
Cure Neurosciences Ltd., developing stem cell-based therapies for
retinal and neurological disorders, including OpRegen®; OncoCyte
Corporation, developing cancer diagnostics; LifeMap Sciences, Inc.,
developing and marketing an integrated online database resource for
biomedical and stem cell research; LifeMap Solutions, Inc., a subsidiary
of LifeMap Sciences, developing mobile health (mHealth) products; ES
Cell International Pte Ltd, which has developed cGMP-compliant human
embryonic stem cell lines that are being marketed by BioTime for
research purposes under the ESI BIO branding program; OrthoCyte
Corporation, developing therapies to treat orthopedic disorders,
diseases, and injuries; and ReCyte Therapeutics, Inc., developing
therapies to treat a variety of cardiovascular and related ischemic
disorders.

BioTime common stock is traded on the NYSE MKT and TASE under the symbol
BTX. For more information, please visit www.biotimeinc.com or
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Forward-Looking Statements

Statements pertaining to future financial and/or operating results,
future growth in research, technology, clinical development, and
potential opportunities for BioTime 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 and its subsidiaries, particularly those mentioned
in the cautionary statements found in BioTime’s Securities and Exchange
Commission filings. BioTime disclaims any intent or obligation to update
these forward-looking statements.

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Contacts

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