Current Report Filing (8-k)
December 15 2015 - 6:06AM
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): December 10, 2015
Bio-Matrix
Scientific Group, Inc.
(Exact
Name of Company as Specified in Charter)
Commission File
Number: 0-32201
|
|
Delaware |
33-0824714 |
(State or Other Jurisdiction of
Incorporation) |
(IRS Employer Identification
Number) |
4700
Spring Street, St 304
La
Mesa California, 91942
(Address
of Principal Executive Offices, Zip Code)
Company’s
telephone number, including area code: (619) 702-1404
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))
Item 8.01 Other Events
On December 10, 2015 Regen
Biopharma, Inc. (“Regen”) was informed by the United States Food and Drug Administration that Regen has satisfactorily
addressed all clinical hold issues related to Regen’s Investigational New Drug Application for HemaXellerate and may initiate
a Phase I clinical trial assessing HemaXellerate in patients with drug-refractory aplastic anemia. The Phase I clinical trial
is intended to determine safety and potential efficacy of intravenously administered autologous stromal vascular fraction (SVF)
cells in patients with severe, immune suppressive refractory aplastic anemia with the primary endpoints of safety and feasibility
and secondary endpoints of efficacy as determined by patients having complete response, partial response or relapse.
HemaXellerate (a therapy
under development by Regen) is a patient-specific composition of cells that have been demonstrated to repair damaged bone marrow
and stimulate production of blood cells based on previous animal studies.
Regen is a controlled
subsidiary of Bio Matrix Scientific Group, Inc.
SIGNATURE
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.
|
Bio
Matrix Scientific Group, Inc. |
|
|
Dated:
December 14, 2015 |
By: /s/
David Koos |
|
David
Koos |
|
Chief
Executive Officer |