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, 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):
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 6,
2010, Oramed Pharmaceuticals Inc. (the “Company”) issued a press release
announcing the results for the recently completed Phase 2b non-FDA clinical
trial of its flagship oral insulin capsule, ORMD-0801 that was 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.
|
ITEM
9.01
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FINANCIAL
STATEMENTS AND EXHIBITS.
|
|
(d)
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Exhibits
|
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99.1
|
Press
Release dated May 6, 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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Dated:
May 6, 2010
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|||
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By:
|
/s/
Nadav Kidron
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||
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Nadav
Kidron
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|||
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President,
CEO and Director
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Exhibit
Index
|
Exhibit
Number
|
Description
|
|
99.1
|
Press
Release dated May 6, 2010
|
Oramed
Pharmaceuticals Reports Results in Phase 2b Trial of Oral Insulin Administration
to Type 2 Diabetes Patients
ORMD-0801
Proves Safe and Tolerable in Type 2 Diabetes Subjects
JERUSALEM,
Israel – May 6, 2010– Oramed Pharmaceuticals Inc. (OTCBB: ORMP), a developer of
alternative drug delivery systems, reported today results for the recently
completed Phase 2b non-FDA clinical trial of its flagship oral insulin capsule,
ORMD-0801.
The
randomized, double-blind, placebo-controlled, multi-centered study conducted in
South Africa evaluated responses of 29 Type 2 diabetes patients to ORMD-0801.
Insulin-loaded or placebo capsules were administered to patients, who were
closely monitored throughout the 6-week study period. Safety, tolerability and
efficacy parameters of Oramed’s oral insulin were assessed.
ORMD-0801
was found to be well tolerated and exhibited a positive safety profile. No
cumulative adverse effects were reported throughout this first study of extended
exposure to ORMD-0801. In addition, the percentage of subjects demonstrating
clinically relevant reductions in insulin, c-peptide, fasting blood glucose and
Hb1Ac levels was always higher in the ORMD-0801 cohort, when compared to the
placebo. Moreover, mean decreases in insulin and CRP levels were found to
be statistically significant following the 6-week, once-daily ORMD-0801
treatment period. These findings suggest that ORMD-0801 attenuates
insulin oversecretion, reprieving beta cells from their heightened
activity. The reported results substantiate the safety and
tolerability of ORMD-0801 and demonstrate that oral insulin has a relevant
clinical impact at the tested dose. The data collected from this
trial will help to further the development of ORMD-0801 in future, pivotal
trials.
Harold
Jacob, M.D., a member of the Oramed Board of Directors, said, “the results of
this trial once again underscore the safety of Oramed's oral insulin
preparation. These results show a positive trend of efficacy for the tested oral
insulin preparation.” Nadav Kidron, Chief Executive Officer of Oramed
Pharmaceuticals, added “this study, as well as data from our earlier studies,
suggests that Oramed’s technology is an effective and well-tolerated delivery
platform that will potentially make a significant clinical impact on diabetes
management. We are proceeding with confidence toward IND approval in
the United States.”
For more
information about Oramed’s clinical development programs, 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.
Company
and Investor Relation Contacts:
Oramed
Pharmaceuticals
Tara
Horn
Office:
646-240-4193
Cell: +
972-54-334-318
Email:
tara@oramed.com