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): September 9, 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
September 9, 2009, Oramed Pharmaceuticals Inc. (the “Company”) issued a press
release announcing that it has received approval from the Institutional Review
Board (IRB) to commence human clinical trials of an oral GLP-1 Analog. This
approval was granted after successful pre-clinical results were reported. The
trials will be conducted on healthy volunteers at Hadassah University Medical
Center in Jerusalem.
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.
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|
(d)
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Exhibits
|
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99.1
|
Press
Release dated September 9, 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:
September 9, 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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Exhibit
Index
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Exhibit
Number
|
Description
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|||||
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99.1
|
Press
Release dated September 9, 2009
|
|||||
Oramed
Pharmaceuticals Commences Human
Clinical Trials of an Oral GLP-1 Analog
ORMD 0901
is being developed as an oral dosage form of a GLP-1 Analog
aimed at
improving glycemic control in adults with type 2 diabetes.
JERUSALEM,
Israel – September 9, 2009 – Oramed Pharmaceuticals Inc. (OTCBB:
ORMP.OB), a developer of oral drug delivery systems, announced today that it has
received approval from the Institutional Review Board (IRB) to commence human
clinical trials of an oral GLP-1 Analog. This approval was granted after
successful pre-clinical results were reported. The trials will be conducted on
healthy volunteers at Hadassah University Medical Center in
Jerusalem.
Currently,
all GLP-1 Analogs are only available as injections. The oral administration of
GLP-1 Analogs may convey physiological advantages for diabetic patients, as the
hormone mimics the physiological route of incretin absorption.
GLP-1 Analogs belongs to
the Incretin family of drugs which have pleiotropic effects desirable in the
management of diabetes. Among the more important effects are the
insulinotropic effects and resultant reduction in blood glucose levels, the
inhibition of glucagon secretion and the restoration of β cell
mass. GLP-1 Analogs are also associated with weight loss, which is very desirable in
patients with diabetes.
“The move
from preclinical trials to human clinical trials of ORMD-0901 marks a strategic
milestone for the company. We have expanded our platform technology and will now
have the opportunity to demonstrate its effectiveness in another important
family of polypeptide drugs for diabetes, which is currently only available in
injection form,” said Oramed CEO Nadav Kidron.
Oramed is
currently conducting Phase 2b clinical trials of its flagship product,
ORMD-0801, an oral insulin capsule.
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 Inc.
Tara
Horn
Cell: +
972-54-334-4318
Office: +
972-2-566-0001
Email:
tara@oramed.com
www.oramed.com