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EX-99.1 - BRAINSTORM CELL THERAPEUTICS INC. | v198753_ex99-1.htm |
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): October 11, 2010
Brainstorm
Cell Therapeutics Inc.
(Exact
name of registrant as specified in its charter)
Delaware
|
333-61610
|
20-8133057
|
||
(State
or other jurisdiction of
incorporation)
|
(Commission
File No.)
|
(IRS
Employer Identification No.)
|
110
East 59 th
Street
|
|
New
York, New York
|
10022
|
(Address
of principal executive offices)
|
(Zip
Code)
|
(212)
557-9000
(Registrant’s
telephone number, including area code)
N/A
(Former
name or former address, if changed since last report)
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:
o Written communications
pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material
pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
o Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
o Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Item
7.01
|
Regulation
FD Disclosure
|
On
October 11, 2010, Brainstorm Cell Therapeutics Inc. (the “Company”) announced that the Israeli Ministry of
Health (“MOH”) has granted clearance for a
Phase I/II clinical trial
using the Company’s
autologous NurOwn™ stem cell therapy in patients with amyotrophic lateral
sclerosis (ALS), often referred to as Lou Gehrig's Disease.
The
clearance granted by the MOH to initiate the clinical trials is
subject to some additional process specifications as well as completion of the
sterility validation study for tests performed in the course of the process (in
process controls) and at the end of the process. The sterility validation study
report will be submitted to the MOH for Its approval.
The
information contained in this Current Report on Form 8-K and the exhibits
attached hereto shall not be deemed to be “filed” for purposes of Section 18 of
the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or
otherwise subject to the liabilities of that section, nor shall such information
or such exhibits be deemed incorporated by reference in any filing under the
Securities Act of 1933, as amended, or the Exchange Act, except as shall be
expressly set forth by specific reference in such a filing. The information set
forth in or exhibits to this Form 8-K shall not be deemed an admission as to the
materiality of any information in this report on Form 8-K.
Item
9.01
|
Financial
Statements and Exhibits
|
The
exhibit listed in the Exhibit Index below is filed with this
report.
2
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.
October
12, 2010
|
Brainstorm
Cell Therapeutics Inc.
|
|
By:
|
/s/
Rami Efrati
|
|
Rami
Efrati
Chief
Executive Officer
|
3
EXHIBIT
INDEX
Exhibit
No.
|
Description
|
|
99.1
|
Press
Release dated October 11, 2010
|
4