Current Report Filing (8-k)
March 14 2019 - 4:07PM
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): March 13, 2019
OWC
Pharmaceutical Research Corp.
(Exact
Name of Registrant as Specified in its Charter)
Commission
File No.: 0-54856
Delaware
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98-0573566
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(State
of Incorporation)
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(I.R.S.
Employer Identification No.)
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2
Ben Gurion Street, Ramat Gan, Israel
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4514760
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(Address
of Principal Executive Offices)
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(Zip
Code)
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Registrant’s
Telephone Number, including area code: 972 (0) 3-758-2657
Not
Applicable
(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 (see General Instruction A.2. below):
[ ]
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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[ ]
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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[ ]
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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[ ]
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company [ ]
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for
complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [ ]
Item
8.01 Other Events.
Execution
of an agreement to perform a Safety and Pharnacokinetic (PK) study of OWC’s soluble tablet versus Sativex®
OWC
Pharmaceutical Research Corp. (“OWC”) is happy to announce the execution of a contract with the Souraski Medical Center
Fund in Tel Aviv for performing a Single-Dose, Randomized, Crossover Study to compare the Safety, Tolerability and Pharmacokinetics
of OWC’s Medical Grade Cannabis - Orally Disintegrating Tablets (MGC-ODT) with Buccal Sativex®, in Healthy Adult Volunteers.
This Clinical Trial Agreement (the “Agreement”) is between One World Cannabis Ltd., a company organized and existing
under the laws of Israel and a wholly-owned subsidiary of OWC, and The Medical, Infrastructure and Health Services Fund of the
Tel Aviv Medical Center, Israel, and Prof. Jacob Ablin M.D. as the Principal Investigator. The primary objectives of the study
are:
1.
To investigate the pharmacokinetics profile of THC, 11-OH THC and CBD following a single sublingual dose of MGC-ODT.
2.
To compare the pharmacokinetic profiles of THC, THC metabolite 11-hydroxy-THC and CBD following a single administration of the
investigational MGC-ODT vs. Sativex® Oromucosal Spray.
3.
To monitor and compare the safety and tolerability of the MGC-ODT and Sativex® in the participating subjects.
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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OWC
PHARMACEUTICAL RESEARCH CORP.
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By:
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/s/
Mordechai Bignitz
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Name:
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Mordechai
Bignitz
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Title:
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Chief
Executive Officer
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Dated:
March 14, 2019
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