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): August 6, 2008
_____________________
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 August
6, 2008, the registrant issued a press release announcing that it
has successfully completed Phase 2B clinical trials on its oral
insulin capsules. 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 August 6, 2008
|
2
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:
August 6, 2008
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|
|
|
|
|
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By:
|
/s/
Nadav Kidron
|
|
|
|
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Nadav
Kidron
|
|
|
|
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President,
CEO and Director
|
3
Oramed
Pharmaceuticals Announces Successful Phase 2A Clinical Trial of its Oral Insulin
Capsule
The
trial
demonstrated the safety and efficacy of the ORMD 0801- oral insulin capsule
JERUSALEM,
Israel - August 6, 2008 - Oramed Pharmaceuticals, Inc. (OTCBB: ORMP.OB;
www.oramed.com),
a
developer of oral delivery systems, announced today successful results from
the
clinical trial of its oral insulin capsule, ORMD 0801. The trial demonstrated
that the product had a good safety profile and was well tolerated and effective
in lowering blood glucose levels in patients with type 2 diabetes.
The
study
was conducted at Hadassah University Medical Center in Jerusalem and was a
continuation of the successful Phase 1B trials that Oramed completed earlier
this year.
This
trial was the first to expose patients with type 2 diabetes to ORMD 0801 and
its
primary goals were to assess the safety, tolerability and pharmcodynamic effects
in these patients.
ORMD
0801
was well tolerated by all patients and had a good safety profile; no serious
adverse events were encountered throughout the study. In 6 of the 9 subjects
analyzed, statistically significant reductions in glucose as well as C-peptide
were observed.
“We
are
pleased with the results from the Phase 2A trial as they showed that ORMD 0801
was effective and there were no safety issues,” said Oramed’s Chief Scientist,
Dr. Miriam Kidron. “We look forward to our next phase of testing and taking the
next steps towards making an oral insulin capsule a reality for millions of
diabetics around the world.”
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
Eric
Rosenberg
Cell:
+
972-54-566-7713
Office:
+
972-2-566-0001
Email:
eric@oramed.com
Media
Contacts:
Ruder
Finn Israel for Oramed
Matthew
Krieger
Cell:
+
972-54-467-6950
Office:
+
972-2-589-2003
Email:
matthew@oramed.com