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): January 20, 2010
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):
[
] 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))
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ITEM
7.01
|
REGULATION
FD DISCLOSURE
|
On
January 19, 2010, Oramed Pharmaceuticals Inc. (the “Company”) issued a press
release announcing the completion of patient enrollment in the Phase 2B clinical
study of its oral insulin capsule, ORMD-0801 conducted in South
Africa.
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.
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ITEM
9.01
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FINANCIAL
STATEMENTS AND EXHIBITS.
|
|
(d)
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Exhibits
|
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99.1
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Press
Release dated January 19, 2010
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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:
January 20, 2010
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By:
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/s/
Nadav Kidron
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Nadav
Kidron
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President,
CEO and Director
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Exhibit
Index
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Exhibit
Number
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Description
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|||||
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99.1
|
Press
Release dated January 19,
2010
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|||||
Oramed Pharmaceuticals Announces
Completion of Patient
Enrollment for Pivotal Phase 2B Clinical Trials of
ORMD-0801
Key Trial for Oral Insulin with Expected Results at the End of Q1 of 2010
JERUSALEM, Israel—January 19, 2009-- Oramed Pharmaceuticals Inc. (OTCBB: ORMP.OB) announced today the completion of
patient enrollment in the Phase 2B clinical study of its oral insulin capsule, ORMD-0801.
The last of the
thirty Type II diabetes patients was enrolled for a study in which
subjects will be administered the insulin-based capsule for a period of six weeks.
The randomized, double-blind,
placebo-controlled, multi-centered study will evaluate the safety,
tolerability, and efficacy
of Oramed’s oral insulin delivery technology.
The study is taking place
in five locations throughout South
Africa and is being
monitored by OnQ Consulting, a clinical research
organization (CRO) based in Johannesburg, South Africa. Study results are expected by the end of first quarter of
2010.
This trial marks an important milestone in ORMD-0801 saftey testing, assessing the first indication of ORMD-0801 on a
large group of volunteers over an extended treatment period.
“The closing of enrollment for the
Phase 2B trial is an exciting
accomplishment for us, as it moves us closer to completing this trial and receiving the
results. In the upcoming
months, we look forward to being able to share
the results from the trial,
which will mark a major milestone in the development of oral insulin”, explained Nadav Kidron, CEO of Oramed
Pharmaceuticals.
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 performed
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
Safe Harbor
Statement
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.
Source: Oramed Pharmaceuticals,
Inc.
Company and Investor Relation
Contacts:
Oramed
Pharmaceuticals
Tara Horn
Cell: + 972-54-334-318Office: +
972-2-566-0001Email:
tara@oramed.com