Current Report Filing (8-k)
October 07 2019 - 9:16AM
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): October 7, 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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Securities
registered pursuant to Section 12(b) of the Exchange Act:
Title
of each class
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Trading
Symbol
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Name
of each exchange on
which
registered
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None
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None
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None
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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.
OWC
Pharmaceutical Research Corp. (“OWC”) announced that, on September 25, 2019, One World Cannabis Ltd., a company organized
and existing under the laws of Israel and a wholly-owned subsidiary of OWC received Top Line Results (TLR) of its single-dose,
randomized, crossover study to compare the safety, tolerability and pharmacokinetics (PK) of OWC’s Medical Grade Cannabis
- Orally Disintegrating Tablets (MGC-ODT) vs. buccal Sativex®, in healthy adult volunteers. The study was conducted at the
Sourasky Medical Center in Tel Aviv. In this study, participants were administered randomly, either Sativex (5.4 mg THC, 5.0 mg
CBD) or OWC-ODT (4.2 mg THC, 5 mg CBD), and then crossed over, with a minimum interval of two weeks. Plasma was collected in the
24 hours following drug administration, at pre-determined time points, and side effects were monitored. The concentrations of
THC, CBD and 11-OH-THC were quantified, and their plasma PK determined.
The
TLR show that both MGC-ODT and Sativex® administration had comparable mean times of peak concentration, half-life and elimination
rates for each of the three analytes (THC, THC metabolite 11-hydroxy-THC and CBD). The results indicated dose-related comparability
of both products in rate of absorption and bioavailability. The incidence of treatment related adverse events (AEs) were similar
between the treatments.
The
most common treatment related AEs were hunger (reported in 25% of subjects treated with MGC-ODT), thirst (reported in 18.75% and
6.25% of subjects treated with MGC-ODT and Sativex®, respectively), dizziness (reported in 18.75% and 18.75% of subjects treated
with MGC-ODT and Sativex®, respectively), dysgeusia (reported in 12.5% and 25% of subjects treated with MGC-ODT and Sativex®,
respectively). Administration of MGC-ODT was judged to be well tolerated and no unexpected safety signals were observed.
Top
Line Results Conclusions: OWC- Orally Disintegrating Tablet is safe to use and appears to have similar PK and bioavailability
as Sativex®. Therefore, OWC intends to apply to the Israel Ministry of Health to obtain necessary approvals to market its
Medical Grade Cannabis - Orally Disintegrating Tablets in Israel.
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:
October 7, 2019
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