Current Report Filing (8-k)
September 15 2014 - 9:06AM
Edgar (US Regulatory)
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): September
15, 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)
|
(Commission File Number)
|
(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
On September 15, 2014, our subsidiary OncoCyte Corporation and Abcodia
Ltd., a UK-based company focusing on the early detection of cancer,
announced their collaboration focused on the development of OncoCyte’s
blood-based PanC-Dx™ test for early detection of breast cancer. PanC-Dx™
is a class of non-invasive cancer diagnostics based on OncoCyte’s
proprietary set of cancer markers, which were discovered by company
scientists through an analysis of broad gene expression patterns in
numerous cancer types. OncoCyte is currently sponsoring four clinical
studies of PanC-Dx™ in bladder, breast, and lung cancer.
Abcodia has exclusive commercial access to a unique longitudinal biobank
of over 5,000,000 serum samples collected through the UK Collaborative
Trial for Ovarian Cancer Screening. The biobank was derived from over
200,000 initially healthy volunteers, 50,000 of whom provided samples
annually for up to 10 years. Since first recruitment, more than 3,700
individuals have been diagnosed with breast cancer, which generates
opportunities to assess serum biomarker changes that occurred years
before the diagnosis of breast cancer was made.
The collaboration will begin with an initial study to be completed by
the end of 2014. Under the terms of the current agreement, OncoCyte will
test the performance of its proprietary PanC-Dx™ cancer markers
in detecting breast cancer in a set of patient samples selected from the
biobank by Abcodia. If the outcome of this initial study is promising,
future studies could proceed and expand into the use of a larger cohort
to assess OncoCyte’s PanC-Dx™ cancer markers in a
case-controlled longitudinal design. Because of the very large number
of samples in the biobank, it may be possible to execute a very large
study of PanC-Dx™ much more quickly than otherwise would be
possible, potentially accelerating the broad commercialization of the
test. The performance of the test in detecting the absence, presence,
and development of early breast cancer will be considered in determining
the intended use for PanC-Dx™ and the regulatory approval pathway
that OncoCyte will pursue. As part of the initial collaboration,
OncoCyte retains all rights to develop and market its proprietary breast
cancer diagnostic products.
The early detection of cancer and its precursors is associated with
improved outcomes for patients. Mammography has been widely used since
the 1970s for breast cancer screening in asymptomatic women; in 2010
over 30 million screening mammograms were performed in the US alone.
Current US National Cancer Institute (NCI) guidelines recommend
screening mammograms every 1 to 2 years in women 40 years and older,
while the American Cancer Society and the National Comprehensive Cancer
Network both recommend screening mammography every year starting at age
40. This screening in women aged 40 to 74 has been associated with
relative reduction in breast cancer mortality of 15% to 20%. However,
the NCI estimates that approximately 20% of all breast cancers are not
detected by mammography during annual screening which indicates there is
an unmet need for a breast-cancer screening test with superior
specificity and sensitivity when compared to standard screening
mammography. PanC-Dx™ does not involve radiation exposure and
could be indicated for all women regardless of age, and could be
performed during the course of regular care with a familiar physician at
low cost.
The collaboration with Abcodia represents an expansion of OncoCyte’s
breast cancer clinical development program, which began early in 2014
with the initiation of an OncoCyte-sponsored 600-patient study at
Scottsdale Medical Imaging Laboratories (SMIL) in Scottsdale, Arizona.
Data from both studies will be used to support an initial use of the
breast cancer diagnostic test by radiologists to aid in determining the
malignancy potential of suspicious mammography findings, and by
oncologists as a tool for recurrence surveillance in breast-cancer
survivors. OncoCyte expects analysis of data from the SMIL cohort should
be also completed by the end of 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: September 15, 2014
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By: /s/ Michael D. West
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Chief Executive Officer
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