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): November 16, 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))
|
ITEM
7.01
|
REGULATION
FD DISCLOSURE
|
On
November 15, 2010, Oramed Pharmaceuticals Inc. issued a press release announcing
that it presented the results of its recently completed Phase IIb trial. The
multicenter, placebo-controlled, randomized, double-blind study conducted in 29
patients with Type II diabetes assessed the safety of ORMD-0801 in patients with
Type II diabetes. Results were presented by the company’s Chief Scientific
Officer, Dr. Miriam Kidron, at the Tenth Annual Meeting of the Diabetes
Technology Society, in Bethesda, Maryland.
A copy of
the press release is attached to this Current Report on Form 8-K as Exhibit 99.1
and is incorporated by reference herein.
|
ITEM
9.01
|
FINANCIAL
STATEMENTS AND EXHIBITS.
|
|
(d)
|
Exhibits
|
|
Exhibit
Number
|
Description
|
|
|
99.1
|
Press
Release dated November 15, 2010.
|
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.
|
|||
|
Dated:
November 16, 2010
|
|||
|
By:
|
/s/
Nadav Kidron
|
||
|
Nadav
Kidron
|
|||
|
President,
CEO and Director
|
|||
Exhibit
Index
|
Exhibit
Number
|
Description
|
|
|
99.1
|
Press
Release dated November 15, 2010.
|
Oramed
Pharmaceuticals Presents Results of its Phase IIb Clinical Trial
at
the
Diabetes Technology Meeting 2010 in Bethesda, MD.
JERUSALEM,
Israel –November 15, 2010 – Oramed Pharmaceuticals Inc. (OTCBB: ORMP.OB; www.oramed.com), a
developer of oral drug delivery systems, presented the results of its recently
completed Phase IIb trial. The multicenter, placebo-controlled, randomized,
double-blind study conducted in 29 patients with Type II diabetes assessed
the safety of ORMD-0801 in patients with Type II diabetes. Results
were presented by the company’s Chief Scientific Officer, Dr. Miriam
Kidron, at the Tenth Annual Meeting of the Diabetes Technology Society, in
Bethesda, Maryland.
The poster presentation entitled “Extended exposure to an oral insulin
formulation yields decreased insulin secretion in Type II diabetes
subjects,” described Oramed's first extended exposure
study to its oral insulin product (ORMD-0801), where 21 patients were treated with ORMD-0801, self-administered daily for a period of six
weeks. In parallel, a group of eight patients received placebo
capsules administered under the same treatment regimen. ORMD-0801 proved safe and tolerable,
with no reports of serious adverse events throughout the study. In
addition, no cumulative effects of extended ORMD-0801 exposure were noted, and
only two mild cases of transient hypoglycemia were
reported. Treatment efficacy was evaluated
via markers quantified from blood samples drawn at the start and end of the study. Daily
administration of oral
insulin led to a statistically significant decrease in both insulin and
C-reactive protein (CRP)
levels, in contrast to
their
elevation among
placebo-treated individuals. Moreover, the percentage of subjects demonstrating clinically relevant reductions in
insulin, c-peptide, fasting blood glucose (FBG) and Hb1Ac levels was
consistently higher in the ORMD-0801 cohort, when compared to its placebo
counterpart. This study addressing, for the first time,
potential
long-term safety concerns from extended ORMD-0801
administrations,
demonstrated safety and no
serious adverse events were reported.
The poster can be viewed
at: http://www.oramed.com/index.php?page=13
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’orporate 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: +
972-54-334-318
Office: +
972-2-566-0001
Email:
tara@oramed.com