SECURITIES AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date
of Report (date of earliest event reported): September
17, 2014
BioTime,
Inc.
(Exact name of registrant as specified in its charter)
California
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1-12830
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94-3127919
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(State or other jurisdiction of incorporation)
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(Commission File Number)
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(IRS Employer
Identification No.)
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1301
Harbor Bay Parkway
Alameda,
California 94502
(Address of principal executive offices)
(510)
521-3390
(Registrant's telephone number, including area
code)
Check the
appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any
of the following provisions:
⃞
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
⃞
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
⃞
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
⃞
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Forward-Looking Statements
Any statements that are not historical fact (including, but not
limited to statements that contain words such as “may, “will,”
“believes,” “plans,” “intends,” “anticipates,” “expects,” “estimates”)
should also be considered to be forward-looking statements. Additional
factors that could cause actual results to differ materially from the
results anticipated in these forward-looking statements are contained in
BioTime’s periodic reports filed with the SEC under the heading “Risk
Factors” and other filings that BioTime may make with the Securities and
Exchange Commission. Undue reliance should not be placed on these
forward-looking statements which speak only as of the date they are
made, and the facts and assumptions underlying these statements may
change. Except as required by law, BioTime disclaims any intent or
obligation to update these forward-looking statements.
This Report and any accompanying exhibits shall be deemed “furnished”
and not “filed” under the Securities Exchange Act of 1934, as amended.
Section 7 - Regulation FD
Item 7.01 - Regulation FD Disclosure
On September 17, 2014, BioTime, Inc. issued the press release furnished
as Exhibit 99.1, which is incorporated by reference.
Section 9 - Financial Statements and Exhibits
Item 9.01 - Financial Statements and Exhibits.
Exhibit Number Description
99.1 Press
Release Dated September 17, 2014
SIGNATURES
Pursuant to
the requirements of the Securities Exchange Act of 1934, the registrant
has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
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BIOTIME, INC.
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Date:
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September
17, 2014
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By:
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/s/ Michael D. West
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Chief Executive Officer
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Exhibit Number Description
99.1 Press
Release Dated September 17, 2014
3
Exhibit 99.1
BioTime’s
Subsidiary Cell Cure Neurosciences Ltd. Demonstrates the Safety and
Efficacy of OpRegen®
in Preclinical Animal Studies
ALAMEDA, Calif. & JERUSALEM--(BUSINESS WIRE)--September 17,
2014--BioTime, Inc. (NYSE MKT: BTX), HBL Hadasit Bio-Holdings Ltd. (Tel
Aviv Stock Exchange: HDST) and Cell Cure Neurosciences Ltd. (Cell Cure)
today announced that Cell Cure has received the final results of a
series of extensive preclinical safety and efficacy studies of its
development-stage product designated OpRegen®,
which is intended for use in the treatment of dry form age-related
macular degeneration (dry-AMD). These studies were conducted by Cell
Cure and contract research organizations in preparation for an IND
filing with the Food and Drug Administration for a Phase 1/2a study in
patients with geographic atrophy, the severe stage of dry-AMD. OpRegen®
consists of retinal pigment epithelial cells derived from human
embryonic stem cells using a proprietary directed differentiation
method. OpRegen® is intended to be administered
into the subretinal space of patients as a suspension of cells to treat
this leading cause of blindness.
“We are very pleased with the safety data obtained in two animal species
that demonstrate that OpRegen® cells
survive following transplantation for a long period of time and do not
result in teratoma formation or any other type of pathology. The
efficacy of the OpRegen® cells was
evaluated in the Royal College of Surgery rat model of retinal
degeneration, which is a well-established animal model of retinal
degeneration which has been extensively used to evaluate various
potential cell therapies. The OpRegen® cells were
found to remain therapeutically functional over long periods and to
maintain the animal’s visual performance that would normally decay over
time in this disease model,” said Benjamin Reubinoff, MD, PhD, Chief
Scientific Officer of Cell Cure and Chairman of Obstetrics and
Gynecology and Director of the Hadassah Human Embryonic Stem Cell
Research Center at Hadassah Medical Center, Jerusalem, Israel.
“Furthermore, the protection of the animal’s vision from decay was dose
dependent. As an additional indicator of therapeutic potential, the
number of cone photoreceptors, which are responsible for fine vision in
humans and are degenerating in the macula of dry-AMD patients, was found
to remain constant over an extended period in the animal model.”
“We are very pleased with the progress that Cell Cure’s team has made in
preparing for the company’s FDA submission,” said Charles S. Irving PhD,
Cell Cure’s CEO. “We look forward to initiating the clinical trial that
will utilize for the first time high quality, xeno-free grade RPE cells
for the treatment of geographic atrophy, the severe stage of dry-AMD.”
About Age-Related Macular Degeneration
Age-related macular degeneration (AMD) is one of the major diseases of
aging and is the leading cause of visual impairment in Americans 55
years of age and older. AMD affects the macula, which is the part of the
retina responsible for sharp, central vision that is important for
facial recognition, reading and driving. There are two forms of AMD. The
dry form (dry-AMD) advances slowly and painlessly until it reaches the
severe form called geographic atrophy (GA), which may result in legal
blindness. About 10% of patients with dry-AMD develop wet-AMD, which is
an acute disease and can lead to blindness in a matter of weeks. Wet-AMD
can be treated with currently-marketed angiogenesis inhibitors such as
Lucentis or Eylea, however, such products typically require frequent
injections, and patients often continue to suffer from the continued
progression of the underlying dry-AMD disease process. There is no
FDA-approved treatment for dry-AMD for which some seven million people
in the US have the intermediate form of the disease and have a high risk
for developing GA. The market opportunity for a treatment for GA has
been estimated at over $5 billion globally. Current estimated sales of
angiogenesis inhibitors for the treatment of the wet form of AMD are
estimated to be about $7 billion worldwide. The root cause of the larger
problem of dry-AMD is believed to be the degeneration of a particular
type of cell in the retina called "retinal pigment epithelial" (RPE)
cells. One of the most exciting therapeutic approaches to dry-AMD is the
transplantation of healthy, young RPE cells to replace the patient’s old
degenerating RPE cells. One of the most promising sources of healthy RPE
cells is from pluripotent stem cells.
About OpRegen®
Cell Cure's OpRegen® consists of RPE cells that
are produced using a proprietary process that drives the differentiation
of human embryonic stem cells into high purity RPE cells. OpRegen®
is also “xeno-free", meaning that no animal products were used either in
the derivation and expansion of the human embryonic stem cells or in the
directed differentiation process. The avoidance of the use of animal
products eliminates some safety concerns. OpRegen®
is formulated as a suspension of RPE cells. Preclinical studies in mice
have shown that OpRegen® transplanted
subretinally as a suspension of cells can rapidly organize into their
natural monolayer structure and survive throughout the lifetime of the
animal. OpRegen® will be an “off-the-shelf”
allogeneic product provided to retinal surgeons in a final formulation
ready for transplantation. Unlike treatments that require multiple
injections into the eye, such as currently-marketed products like
Lucentis and Eylea for wet-AMD, it is expected that OpRegen®
will be administered in a single procedure.
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.
(NYSE MKT: BTX). Cell Cure’s second largest shareholder is HBL Hadasit
Bio-Holdings, (TASE: HDST, OTC: HADSY). Cell Cure is located in
Jerusalem, Israel on the campus of Hadassah Medical Center. Cell Cure's
mission is to become a leading supplier of human 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-compatible) 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., HBL Hadasit Bio-Holdings Ltd.,
Teva Pharmaceuticals Industries Ltd. (NYSE: TEVA), and Asterias
Biotherapeutics (OTCBB: ASTY). Additional information about Cell Cure
can be found on the web at www.cellcureneurosciences.com. A video
of a presentation by Cell Cure’s CEO Dr. Charles Irving is available on
BioTime’s web site.
About BioTime
BioTime is a biotechnology company engaged in research and product
development in the field of regenerative medicine. Regenerative medicine
refers to therapies based on stem cell technology that are designed to
rebuild cell and tissue function lost due to degenerative disease or
injury. BioTime’s focus is on pluripotent stem cell technology based on
human embryonic stem (“hES”) cells and induced pluripotent stem (“iPS”)
cells. hES and iPS cells provide a means of manufacturing every cell
type in the human body and therefore show considerable promise for the
development of a number of new therapeutic products. BioTime’s
therapeutic and research products include a wide array of proprietary PureStem®
progenitors, HyStem® hydrogels, culture media,
and differentiation kits. BioTime is developing Renevia™ (a HyStem®
product) as a biocompatible, implantable hyaluronan and collagen-based
matrix for cell delivery in human clinical applications, and is planning
to initiate a pivotal clinical trial around Renevia™, in 2014. In
addition, BioTime has developed Hextend®, a blood
plasma volume expander for use in surgery, emergency trauma treatment
and other applications. Hextend® is manufactured
and distributed in the U.S. by Hospira, Inc. and in South Korea by CJ
HealthCare Corporation, under exclusive licensing agreements.
BioTime is also developing stem cell and other products for research,
therapeutic, and diagnostic use through its subsidiaries:
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Asterias Biotherapeutics, Inc. is developing pluripotent
stem-cell based therapies in neurology and oncology, including
AST-OPC1 oligodendrocyte progenitor cells in spinal cord injury,
multiple sclerosis and stroke, and AST-VAC2, an allogeneic dendritic
cell-based cancer vaccine. Asterias trades publicly under the symbol
ASTY.
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BioTime Asia, Ltd., a Hong Kong company, may offer and sell
products for research use for BioTime’s ESI BIO Division.
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Cell Cure Neurosciences Ltd. is an Israel-based biotechnology
company focused on developing stem cell-based therapies for retinal
and neurological disorders, including the development of retinal
pigment epithelial cells for the treatment of macular degeneration,
and treatments for multiple sclerosis.
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ESI BIO is the research and product marketing division of
BioTime, providing stem cell researchers with products and
technologies to enable them to translate their work into the clinic,
including PureStem® progenitors and HyStem®
hydrogels.
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LifeMap Sciences, Inc. markets, sells, and distributes GeneCards®,
the leading human gene database, as part of an integrated database
suite that also includes the LifeMap Discovery®
database of embryonic development, stem cell research, and
regenerative medicine, and MalaCards, the human disease
database.
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LifeMap Solutions, Inc. is a subsidiary of LifeMap Sciences
focused on developing mobile health (mHealth) products.
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OncoCyte Corporation is developing products and technologies to
diagnose and treat cancer, including PanC-Dx™, with three
clinical trials currently underway.
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OrthoCyte Corporation is developing therapies to treat
orthopedic disorders, diseases and injuries.
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ReCyte Therapeutics, Inc. is developing therapies to treat a
variety of cardiovascular and related ischemic disorders, as well as
products for research using cell reprogramming technology.
BioTime stock is traded on the NYSE MKT, ticker BTX. For more
information, please visit www.biotimeinc.com or
connect with the company on Twitter, LinkedIn, Facebook, YouTube, and
Google+.
About HBL Hadasit Bio-Holdings Ltd., Inc.
HBL Hadasit Bio-Holdings Ltd. (“HBL”) (TASE: HDST, OTC: HADSY) was
established and issued by HADASIT (the technology transfer company of
the Hadassah University Hospital) in 2006 with the aim to promote the
knowledge and experience gained from the research laboratories of
Hadassah Medical Center. HBL holds equity in six biotechnology
companies, all of which have already demonstrated feasibility - efficacy
in animal models, and - three of which are already in human clinical
trials. Companies included in HBL are companies that develop drugs with
blockbuster potential (markets designated totaling over a billion
dollars) active in the fields of cancer, inflammatory diseases and
tissue regeneration using stem cells - areas in which the Hadassah
Medical Center has vast expertise and global leadership. HBL is managed
by Tami Kfir. For more information visit our website: www.hbl.co.il
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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following link to join our email alert list: http://news.biotimeinc.com
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CONTACT:
BioTime, Inc.
Judith Segall, 510-521-3390 ext. 301
jsegall@biotimemail.com
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