UNITED STATES
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): July
31, 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.
Section 8 – Other Events
Item 8.01 Other Events
Our subsidiary OncoCyte Corporation has expanded the clinical
development of its urine-based bladder cancer diagnostic test by
initiating a multi-site clinical trial. The trial, which will involve up
to 1,200 patient samples obtained from at least four large urology
clinics located throughout the United States, has received Institutional
Review Board (IRB) approval at multiple sites and should begin enrolling
patients within the next week. OncoCyte’s initial clinical study of its
bladder cancer diagnostic test began in January and involves pathology
specimens being collected at a leading medical institution with an
international reputation for excellence and discovery. The multi-site
clinical trial, which has been initiated in part due to positive interim
data from the ongoing study in pathology specimens, is designed to
expand the potential use of the PanC-Dx™ bladder cancer test
beyond pathology laboratories and into urologic practices at the point
of cystoscopy. Cystoscopy along with urine cytopathology, are the
standard methods utilized for bladder cancer screening and diagnosis.
The multi-site clinical trial should be completed within 12 months.
The goal of the current clinical trial is to compare the performance of
OncoCyte’s proprietary PanC-Dx™ bladder cancer markers to
the performance of cystoscopy. Investigators in the trial are collecting
urine samples from patients undergoing cystoscopy for the diagnosis of
either primary or recurrent bladder cancer. Cystoscopy and biopsy
results will be compared with the results of OncoCyte’s proprietary
diagnostic test panel in determining the overall performance of the PanC-Dx™
markers. PanC-Dx™ is a class of non-invasive cancer
diagnostics based on OncoCyte’s proprietary set of cancer markers
discovered by OncoCyte scientists through an analysis of broad gene
expression patterns in numerous cancer types. The performance of the
test in detecting the absence, presence, or progression of urothelial
carcinoma in patients will determine the specific nature of the bladder
cancer diagnostic to be developed and the regulatory approval pathway
that OncoCyte will pursue.
Urothelial carcinoma (UC) constitutes more than 90% of bladder cancers
in the Americas, Europe and Asia. Although most patients with bladder
cancer can be treated with organ-sparing chemotherapy, UC has a relapse
rate of nearly 70% and can progress to invasive, metastatic, and lethal
disease. The regular surveillance and treatment of recurrent disease
from the time of diagnosis for the remainder of a patient’s life makes
UC the most costly malignancy on a per patient basis. The problem is
amplified because the two standard methods for surveillance -
microscopic assessment of urinary cytology specimens and bladder
cystoscopy– possess significant limitations with respect to both
performance and cost. Although urine cytology does have a very high
positive predictive value (low false positive rate), it has a low
negative predictive value and a high indeterminate rate. Patients who
have indeterminate urine cytology results commonly undergo cystoscopy,
which is painful, time consuming, costly, and unnecessary in many cases
since a neoplasm is often not present. In UC, as in virtually all other
cancers, earlier and more accurate diagnosis, including diagnosis of
disease recurrence, is generally associated with better outcomes and
lower cost.
Overall markets for bladder cancer diagnostics are large and growing.
Based on National Cancer Institute statistics released in 2012, it was
estimated that in 2013 over 72,000 new cases of bladder cancer would
occur in the United States and a total of over 550,000 men and women
alive would have a history of bladder cancer and be subject to
recurrence surveillance testing using cystoscopy or urine cytology.
Section 9 - Financial Statements and Exhibits
Item 9.01 Financial Statements and Exhibits.
Exhibit Number Description
99.1 Press Release Dated July 31, 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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July
31, 2014
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By:
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/s/ Robert W. Peabody
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Senior Vice President,
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Chief Operating Officer,
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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 July 31, 2014
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Exhibit 99.1
BioTime,
Inc. Subsidiary OncoCyte Corporation Expands Clinical Development of
Bladder Cancer Diagnostic by Initiating a Large Multi-Site Clinical Trial
- PanC-Dx™
Markers
to be Tested on Over 1,000 Patient Samples from Urology Clinics Located
Throughout United States-
ALAMEDA, Calif.--(BUSINESS WIRE)--July 31, 2014--BioTime, Inc. (NYSE
MKT: BTX) and its subsidiary OncoCyte Corporation today announced that
OncoCyte has expanded the clinical development of its urine-based
bladder cancer diagnostic test by initiating a multi-site clinical
trial. The trial, which will involve up to 1,200 patient samples
obtained from at least four large urology clinics located throughout the
United States, has received Institutional Review Board (IRB) approval at
multiple sites and should begin enrolling patients within the next week.
OncoCyte’s initial clinical study of its bladder cancer diagnostic test
began in January and involves pathology specimens being collected at a
leading medical institution with an international reputation for
excellence and discovery. The multi-site clinical trial, which has been
initiated in part due to positive interim data from the ongoing study in
pathology specimens, is designed to expand the potential use of the PanC-Dx™
bladder cancer test beyond pathology laboratories and into urologic
practices at the point of cystoscopy. Cystoscopy along with urine
cytopathology, are the standard methods utilized for bladder cancer
screening and diagnosis. The multi-site clinical trial should be
completed within 12 months.
The goal of the current clinical trial is to compare the performance of
OncoCyte’s proprietary PanC-Dx™ bladder cancer markers to
the performance of cystoscopy. Investigators in the trial are collecting
urine samples from patients undergoing cystoscopy for the diagnosis of
either primary or recurrent bladder cancer. Cystoscopy and biopsy
results will be compared with the results of OncoCyte’s proprietary
diagnostic test panel in determining the overall performance of the PanC-Dx™
markers. PanC-Dx™ is a class of non-invasive cancer
diagnostics based on OncoCyte’s proprietary set of cancer markers
discovered by OncoCyte scientists through an analysis of broad gene
expression patterns in numerous cancer types. The performance of the
test in detecting the absence, presence, or progression of urothelial
carcinoma in patients will determine the specific nature of the bladder
cancer diagnostic to be developed and the regulatory approval pathway
that OncoCyte will pursue.
“A urine-based test that accurately discriminates between cancer and
benign disease would be of great value. I look forward to working with
OncoCyte in helping to develop such a test,” said Neal Shore, M.D.,
Study Investigator and Medical Director of the Carolina Urologic
Research Center (CURC), an independent research arm of Atlantic Urology
Clinics in Myrtle Beach, South Carolina. Under the direction of Dr.
Shore, CURC conducts phase I - IV drug, biotechnology and device trials
focusing on urological diseases. CURC has been recognized both
nationally and internationally as one of the most progressive,
well-organized, and respected clinical research sites in the United
States.
Urothelial carcinoma (UC) constitutes more than 90% of bladder cancers
in the Americas, Europe and Asia. Although most patients with bladder
cancer can be treated with organ-sparing chemotherapy, UC has a relapse
rate of nearly 70% and can progress to invasive, metastatic, and lethal
disease. The regular surveillance and treatment of recurrent disease
from the time of diagnosis for the remainder of a patient’s life makes
UC the most costly malignancy on a per patient basis. The problem is
amplified because the two standard methods for surveillance -
microscopic assessment of urinary cytology specimens and bladder
cystoscopy– possess significant limitations with respect to both
performance and cost. Although urine cytology does have a very high
positive predictive value (low false positive rate), it has a low
negative predictive value and a high indeterminate rate. Patients who
have indeterminate urine cytology results commonly undergo cystoscopy,
which is painful, time consuming, costly, and unnecessary in many cases
since a neoplasm is often not present. In UC, as in virtually all other
cancers, earlier and more accurate diagnosis, including diagnosis of
disease recurrence, is generally associated with better outcomes and
lower cost.
Overall markets for bladder cancer diagnostics are large and growing.
Based on National Cancer Institute statistics released in 2012, it was
estimated that in 2013 over 72,000 new cases of bladder cancer would
occur in the United States and a total of over 550,000 men and women
alive would have a history of bladder cancer and be subject to
recurrence surveillance testing using cystoscopy or urine cytology.
Given this large and growing clinical population, as well as the
limitations of current diagnostic methods, a non-invasive and effective
bladder cancer screening test could have a significant market
opportunity.
“High performing, non-invasive cancer screening diagnostic tests have
multiple potential users. In the case of our urine-based bladder cancer
diagnostic, we believe urologists and pathologists would be the major
adopters of the test. In order to gain test adoption, we believe it is
critical to not only generate valid clinical performance data, but also
to integrate each user group into clinical trials so specific user needs
can be engineered into the ultimate product. The first clinical study of
our bladder cancer diagnostic that started earlier this year focused on
integrating the needs of the pathologist into the test. This second
study now aims to integrate the needs of the urology community into the
test. We believe this strategy will result in a product that will be
rapidly adopted as it will fit unmet, real-world clinical needs,” said
Joseph Wagner, PhD, OncoCyte’s Chief Executive Officer.
Share this news via Twitter:
-
Click to Tweet: BioTime subsidiary OncoCyte Initiates Large
Multi-Site Clinical Trial for Bladder Diagnostic PanC-Dx. $BTX http://ctt.ec/fTEG3+
About OncoCyte Corporation
OncoCyte, a majority-owned subsidiary of BioTime, Inc., is developing
novel products for the diagnosis and treatment of cancer in order to
improve the quality and length of life of cancer patients. Based on
large unmet need, market size, and data generated thus far from patient
sample screening, OncoCyte is initially focusing its efforts on
developing PanC-Dx™ diagnostic products for use in detecting
breast, bladder, and lung cancers. PanC-Dx™ is a class of
non-invasive cancer diagnostics based on a proprietary set of cancer
markers characterized, in part, by broad gene expression patterns in
numerous cancer types. The PanC-Dx™ biomarkers were discovered as
a result of ongoing research within OncoCyte and BioTime on the gene
expression patterns associated with embryonic development. This research
has demonstrated that many of the same genes associated with normal
growth during development are abnormally reactivated by cancer cells.
These genes regulate such diverse processes as cell proliferation, cell
migration and blood vessel formation. Many of these genes have not been
previously associated with cancer. Moreover, expression of a large
subset of these genes is conserved across numerous cancer types (e.g.
cancers of the breast, colon, ovaries, etc.), suggesting these genes may
control fundamental processes during cancer growth and progression. In
addition to their potential value in developing diagnostic biomarkers,
an understanding of the pattern of expression of these genes may also
enable the development of powerful new cancer therapeutics that target
rapidly proliferating cancer cells.
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.
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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 Market exchange, ticker BTX. For
more information, please visit www.biotimeinc.com or
connect with the company on Twitter, LinkedIn, Facebook, YouTube, and
Google+.
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.
To receive ongoing BioTime corporate communications, please click on the
following link to join our email alert list: http://news.biotimeinc.com
CONTACT:
BioTime, Inc.
Judith Segall, 510-521-3390, ext. 301
jsegall@biotimemail.com
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