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): April 29, 2009
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))
Statements made in this Report that
are not historical facts may constitute forward-looking statements that are
subject to risks and uncertainties that could cause actual results to differ
materially from those discussed. Such risks and uncertainties include
but are not limited to those discussed in this report and in BioTime's Annual
Report on Form 10-K filed with the Securities and Exchange Commission. Words
such as “expects,” “may,” “will,” “anticipates,” “intends,” “plans,” “believes,”
“seeks,” “estimates,” and similar expressions identify forward-looking
statements.
Section
8 – Other Events
Item
8.01 – Other Events
On April
29, 2009, the California Institute of Regenerative Medicine (CIRM) awarded us a
$4,721,706 grant for a stem cell research project related to our ACTCellerate™
embryonic stem cell technology. Our grant project is titled
“Addressing the Cell Purity and Identity Bottleneck through Generation and
Expansion of Clonal Human Embryonic Progenitor Cell Lines.” The
overall objective of the research project is to generate tools useful in
applying ACTCellerate™ technology to the manufacture of patient-specific
therapeutic products.
Our
CIRM-funded research project will address the need for industrial scale
production of pure therapeutic cells. Our technologies in
regenerative medicine are based on the power of human embryonic stem (hES) cells
and induced pluripotent stem (iPS) cells to become all of the cell types of the
human body. hES and iPS-derived cells are generally difficult and
costly to manufacture in large quantities, especially with the purity required
for therapeutic use. Purity and precise identification of the desired
therapeutic cells are essential for cell therapy because unlike a drug which may
persist in the body for a matter of hours or days, a cell can persist in the
body for a lifetime. Contamination of hES- or iPS-derived cells with
the wrong cells could lead to toxicities resulting from normal but inappropriate
tissue growth or tumor formation.
ACTCellerate™
technology addresses the challenges of manufacturing purified cells of known
identity by allowing the isolation of novel, highly-purified embryonic
progenitor cells (hEPCs). Embryonic progenitors are cells that are
intermediate in the developmental process between embryonic stem cells and fully
differentiated cells. Progenitor cells may possess the ability to
become a wide array of cell types with potential applications in research, drug
discovery, and human regenerative stem cell therapy. The progenitor
cells are relatively easy to manufacture on a large scale and in a purified
state, which may make it advantageous to work with these cells compared to the
direct use of hES or human iPS cells. We already have isolated and
expanded a number of hEPCs that may be used in the funded research
program.
Because
hEPCs are clonal, meaning that they are derived from a single cell, they have
the potential to grow as a pure cell line. However, the production of
hEPCs for human therapeutic use will require a means of ascertaining that the
cells being used are in fact the correct cells. Our research program
proposes to map the surface markers on hEPC lines so that we can identify a
molecular signature specific to a given hEPC line. The molecular
signature will be the key to verifying the correct identity of cells intended to
be used in therapy, and
2
will
facilitate purification of hEPCs from any hES or iPS cell line. We
will seek to identify antibodies and other cell purification reagents that will
reveal the molecular signature of the desired hEPCs. The successful
completion of our proposed project will provide well characterized hEPCs that
are precursors of therapeutic cells such as nerve, blood vessel, heart muscle,
and skin.
CIRM's
independent reviewers who recommended funding of the grant concluded that our
research project “addresses an unmet need in the field, is innovative, and has
sound scientific rationale. If successful, the applicant’s work would
benefit the field by providing: 1) a shared bank of standardized good
manufacturing practice (GMP)-produced hEPCs with methods for industrial scale up
of the lines; 2) peptide and antibody reagents with protocols for identification
and isolation of hEPCs; and 3) reagents and protocols for differentiating hEPCs
to clinically relevant cells. Reviewers concurred that these
resources would help advance stem cell therapies to the clinic.”
The CIRM
grant will provide up to $4.7 million of funding for this research project over
a period of three years, with $1.6 million expected to be available during the
first 12 months. We expect that the first funds will be available
some time during the summer of 2009 and that work on the project will be ready
to begin upon the receipt of funding.
CIRM was
established in 2005 to fund over $3 billion dollars of research in the field of
stem cell biology in California. In particular, it aims to support
and advance stem cell research and regenerative medicine under the highest
ethical and medical standards for the discovery and development of cures,
therapies, diagnostics and research technologies to relieve human suffering from
chronic disease and injury. With this level of funding, CIRM is the
largest source of funding for embryonic and pluripotent stem cell research in
the world. CIRM's website can be found at
http://www.cirm.ca.gov.
Section
9 – Financial
Statements and Exhibits
Item
9.01 –
Financial Statements and Exhibits.
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Exhibit Number
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Description
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99.1
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Press
Release Dated April 30,
2009
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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: April
30, 2009
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By
/s/ Steven A.
Seinberg
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Chief
Financial Officer
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4
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Exhibit Number
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Description
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99.1
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Press
Release Dated April 30, 2009
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Exhibit
99.1
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BioTime,
Inc.
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1301
Harbor Bay Parkway
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Alameda,
CA 94502
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||
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Tel:
510-521-3390
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Fax:
510-521-3389
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www.biotimeinc.com
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www.embryome.com
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BioTime
Awarded a $4.7 Million Research Grant from the California Institute for
Regenerative Medicine
—
Grant to fund expansion of BioTime’s ACTCellerate™ human embryonic stem cell
product development —
ALAMEDA, CA, April 30, 2009 –BioTime, Inc., (OTCBB:
BTIM) announced today that the California Institute for Regenerative
Medicine (CIRM) has approved a grant to the Company of $4.7 million to fund
research related to its ACTCellerate™ embryonic stem cell technology. The
overall objective of this grant is to generate tools useful in applying
ACTCellerate™ technology to the manufacture of patient-specific therapeutic
products.
BioTime’s
technologies in regenerative medicine are based on the power of human embryonic
stem (hES) cells and induced pluripotent stem (iPS) cells to become all of the
cell types of the human body. There is a significant business opportunity in
both the research and therapeutic sector for marketing the hundreds of human
cell types that come from these stem cells. However, one of the greatest
challenges for stem cell researchers is to identify methods to isolate the many
hundreds of human cell types in a purified state.
The new
grant funds awarded by CIRM will be used by BioTime to “industrialize” the
manufacture of the purified cell types for therapeutic
applications. In particular, the aims of the grant are to generate tools
useful in implementing ACTCellerate™ technology in a patient-specific manner,
such as from a patient’s own cells. Both BioTime and CIRM anticipate that the
funded research may accelerate the translation of bench top science to bedside
treatments for presently incurable diseases.
ACTCellerate™
is a novel technology that allows the expansion of over 140 highly-purified
primitive human embryonic progenitor cells (hEPCs) from hES or iPS cells.
These hEPCs may possess the ability to become a wide array of cell types with
potential applications in research, drug discovery, and human regenerative stem
cell therapy. BioTime already has isolated and expanded a number of hEPCs
that are being marketed for research purposes only through the Company’s wholly
owned subsidiary, Embryome Sciences, Inc.
CIRM was
established in 2005 to fund over $3 billion dollars of research in the field of
stem cell biology in California. In particular, it aims to support and advance
stem cell research and regenerative medicine under the highest ethical and
medical standards for the discovery and development of cures, therapies,
diagnostics, and research technologies to relieve human suffering from chronic
disease and injury. With this level of funding, CIRM is the largest source of
funding for embryonic and pluripotent stem cell research in the world. CIRM's
website can be found at http://www.cirm.ca.gov.
BioTime’s
grant titled “Addressing the Cell Purity and Identity Bottleneck through
Generation and Expansion of Clonal Human Embryonic Progenitor Cell Lines” was
recommended for funding by CIRM's independent reviewers. The
reviewer’s statement concluded that the “proposal addresses an unmet need in the
field, is innovative, and has sound scientific rationale. If successful, the
applicant’s work would benefit the field by providing: 1) a shared bank of
standardized good manufacturing practice (GMP)-produced hEPCs with methods for
industrial scale up of the lines; 2) peptide and antibody reagents with
protocols for identification and isolation of hEPCs; and 3) reagents and
protocols for differentiating hEPCs to clinically relevant cells. Reviewers
concurred that these resources would help advance stem cell therapies to the
clinic.”
“With
these Early Translational grants, CIRM has taken the first step in funding
translational research that will be critical for the development of future
therapies,” said Alan Trounson, CIRM president. “These grants are an important
part of CIRM’s strategy to fund the best basic research and then bring the
results of that work to patients.”
“We
deeply appreciate the generous support of the people of California for our
research and product development,” said Dr. Michael D. West, BioTime’s Chief
Executive Officer, who is the Principal Investigator on the grant. “This CIRM
grant will allow us to offer important new products to stem cell researchers
sooner than we had previously planned. We intend to compete for CIRM grant
support for other programs as well. Such programs include iPS technology in the
preclinical studies of the therapeutic uses of our technology, such as their use
in the treatment of neurological, vascular, and orthopedic
diseases.”
Background
Regenerative
medicine refers to therapies based on human embryonic stem (hES) cell or induced
pluripotent stem (iPS) cell technology, designed to regenerate tissues afflicted
with degenerative disease. The great scientific and public interest in
regenerative medicine lies in the potential of hES and iPS cells to transform
into any cell type of the human body. hES and iPS cells therefore
show considerable potential as sources of new therapies for a host of currently
incurable diseases such as diabetes, stroke, Parkinson’s disease, Alzheimer’s
disease, heart failure, arthritis, muscular dystrophy, spinal cord injury,
macular degeneration, hearing loss, liver failure, and many other disorders
where cells become dysfunctional.
ACTCellerate™
technology allows the isolation of novel, highly-purified embryonic progenitor
cells (hEPCs). Embryonic progenitors are cells that are intermediate
in the developmental process between embryonic stem cells and
fully-differentiated cells. These progenitor cells may possess the ability to
become a wide array of cell types with potential applications in research, drug
discovery, and human regenerative stem cell therapy. Embryonic
progenitor cells are relatively easy to manufacture on a large scale and in a
purified state, which may make it advantageous to scale up these cells in the
manufacturing process rather than scaling embryonic stem cells. BioTime’s
subsidiary, Embryome Sciences, Inc., sells progenitor cells, and the specific
culture media that stimulate the propagation of the cells, to the research
community through the company’s website Embryome.com. BioTime
and
Embryome Sciences may also collaborate with others in the development of human
therapeutic uses of the cell lines.
2
BioTime’s
CIRM-funded research will address the need for the industrial-scale
manufacture of purified therapeutic cells. Purity and precise
identification of the desired cells are essential for therapy because unlike a
drug, which may persist in the body for a matter of hours or days, a cell can
persist in the body for a lifetime. Contamination of transplanted cells
with cells of an unintended type could lead to serious complications, even tumor
formation. The CIRM grant will provide up to $4.7 million of funding for
this research project over a period of three years, with $1.6 million expected
to be available during the first 12 months. BioTime expects that the
first funds will be available some time during the summer of 2009 and that work
on the project will be ready to begin upon the receipt of funding.
Embryome
Sciences is presently marketing a family of cell growth media called ESpanTM. These
growth media are optimized for the growth of human embryonic progenitor
cells. Additional new products that Embryome Sciences has targeted
for development are ESpyTM
cell lines, which will be derivatives of hES cells that send beacons of light in
response to the activation of particular genes. Embryome Sciences also plans to
bring to market cells carrying specific disease genes in collaboration with the
Reproductive Genetics Institute of Chicago, Illinois; new growth and
differentiation factors that will permit researchers to manufacture
specific cell types from embryonic stem cells; and purification tools useful to
researchers in quality control of products for regenerative
medicine.
About
BioTime, Inc.
BioTime,
headquartered in Alameda, California, is a biotechnology company focused on the
emerging field of regenerative medicine. BioTime's lead product Hextend is a
blood plasma expander used 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 CheilJedang Corp. under exclusive
licensing agreements.
BioTime
markets its stem cell research products through its wholly owned subsidiary
Embryome Sciences,
Inc. which is developing new medical and research products using
embryonic stem cell technology. Additional information about BioTime
can be found on the web at www.biotimeinc.com.
Hextend®,
ESpyTM, and
ESpanTM, are
trademarks of BioTime, Inc.
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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 the
company and its subsidiary, 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 company's business, particularly those
mentioned in the cautionary statements found in the company's Securities and
Exchange Commission filings. The company disclaims any intent or obligation to
update these forward-looking statements.
Contact:
BioTime,
Inc.
Judith
Segall
jsegall@biotimemail.com
510-521-3390
To
receive ongoing BioTime corporate communications, please click on the following
link to join our email alert list: http://www.b2i.us/irpass.asp?BzID=1152&to=ea&s=0
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