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)
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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
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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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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