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): May 6, 2009
_____________________
ORAMED
PHARMACEUTICALS INC.
(Exact
name of registrant as specified in its charter)
|
Nevada
(State
or other jurisdiction
of
incorporation)
|
000-50298
(Commission
File Number)
|
98-0376008
(IRS
Employer
Identification
No.)
|
Hi-Tech
Park 2/5 Givat Ram
PO
Box 39098
Jerusalem,
Israel 91390
(Address
of principal executive offices and zip code)
Registrant’s
telephone number, including area code: 972-2-566-0001
_____________________
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):
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 May 5,
2009, Oramed Pharmaceuticals Inc. (the “Company”) issued a press release
announcing that Phase 2b clinical trials
will commence this week on 30 Type 2 Diabetic volunteers.
A copy of
the press release is attached to this Current Report on Form 8-K as Exhibit 99.1
and is incorporated herein by reference.
|
ITEM
9.01
|
FINANCIAL
STATEMENTS AND EXHIBITS.
|
|
(d)
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Exhibits
|
|
99.1
|
Press
Release dated May 5, 2009
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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.
|
ORAMED PHARMACEUTICALS
INC.
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|||
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Dated:
May 6, 2009
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|||
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By:
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/s/
Nadav Kidron
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||
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Nadav
Kidron
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|||
|
President,
CEO and
Director
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Oramed
Pharmaceuticals Announces Launch of Phase 2B Clinical Trials in South Africa of
its Oral Insulin Capsule
JERUSALEM,
Israel – May 5, 2009 – Oramed Pharmaceuticals, Inc. (OTCBB: ORMP.OB; www.oramed.com),
a developer of oral delivery systems, announced that Phase 2b clinical trials
will commence this week on 30 Type 2 Diabetic volunteers. The study is intended
to evaluate the safety, tolerability and efficacy of its oral insulin capsule
ORMD-0801. OnQ Consulting, a clinical research organization (CRO) located in
Johannesburg, South Africa, will oversee the clinical trials. This
trial is an important milestone for Oramed as it will test its first indication
for ORMD-0801 on a large group of volunteers for the duration of six
weeks.
This six
week randomized, double blind placebo controlled study will be performed in
three locations in Cape Town. The principle investigators of the study will be
renowned South African Endocrinologists.
“We are
pleased to begin this study of ORMD-0801 on Type 2 diabetes patients following
our successful 2A clinical trials in August 2008. This trial is an
important milestone for Oramed as this is the first trial for ORMD-0801 on a
larger group of volunteers for a longer duration.” said Oramed’s CEO, Mr. Nadav
Kidron.
About
Oramed Pharmaceuticals
Oramed
Pharmaceuticals is a technology pioneer in the field of oral delivery solutions
for drugs and vaccines presently delivered via injection. Oramed is seeking
to revolutionize the treatment of diabetes through its patented flagship
product, an orally ingestible insulin capsule currently in phase 2 clinical
trials. Established in 2006, Oramed’s technology is based on over 25 years of
research by top research scientists at Jerusalem’s Hadassah Medical Center. The
Company’s corporate and R&D headquarters are based in
Jerusalem.
For more
information, please visit www.oramed.com
Forward-looking
statements
Some of
the statements contained in this press release are forward-looking statements
which involve known and unknown risks, uncertainties and other factors which may
cause the actual results, performance or achievements of the company, or
industry results, to be materially different from any future results,
performance or achievements expressed or implied by such forward looking
statements, including the risks and uncertainties related to the progress,
timing, cost, and results of clinical trials and product development programs;
difficulties or delays in obtaining regulatory approval for our product
candidates; competition from other pharmaceutical or biotechnology companies;
and the company’s ability to obtain additional funding required to conduct its
research, development and commercialization activities. Please refer to the
company’s filings with the Securities and Exchange Commission for a
comprehensive list of risk factors that could cause actual results, performance
or achievements of the company to differ materially from those expressed or
implied in such forward looking statements. The company undertakes no obligation
to update or revise any forward-looking statements.
Company
and Investor Relation Contacts:
Oramed
Pharmaceuticals
Tara
Horn
Cell: +
972-54-334-318
Office: +
972-2-566-0001
Email:
tara@oramed.com