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 24, 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):
[
] 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 September
24, 2008, the registrant issued a press release announcing that it
has launched Phase 2A trials to assess the safety and efficacy of ORMD
0801, its oral insulin capsule, on Type 1 diabetics. 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)
|
Exhibits
|
|
|
99.1
|
Press
Release dated September 24, 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:
September 24, 2008
|
|
|
|
|
|
|
By:
|
/s/
Nadav Kidron
|
|
|
|
|
Nadav
Kidron
|
|
|
|
|
President,
CEO and Director
|
3
ORAMED
PHARMACEUTICALS COMMENCES PHASE 2A TRIALS OF ITS
ORAL
INSULIN CAPSULE ON TYPE 1 DIABETICS
Study
to
assess the safety and efficacy of ORMD 0801,oral insulin capsule, on Type 1
diabetics
JERUSALEM,
Israel - September 24, 2008 - Oramed Pharmaceuticals, Inc. (OTCBB: ORMP.OB;
www.oramed.com),
a
developer of oral delivery systems, announced today that it has commenced Phase
2A studies of ORMD 0801, its oral insulin capsule, on Type 1 diabetics at the
Hadassah University Medical Center in Jerusalem, Israel.
Oramed’s
Phase 2A trial is focused on assessing the safety and efficacy of its oral
insulin capsule on nine Type 1 diabetes patients.
The
start
of this clinical trial on Type 1 Diabetic patients follows completion by the
company of similar trials on Type 2 diabetic patients, which demonstrated that
ORMD 0801 had a good safety profile and was effective in lowering blood glucose
levels without any serious adverse events.
“The
commencement of trials of our oral insulin capsule on Type 1 diabetics signals
another major step forward for our company in the treatment of diabetes,” said
Nadav Kidron, Oramed CEO. “The successful results from our trials on Type 2
diabetics were very encouraging and we hope to achieve similar results from
our
Type 1 trials as
well.”
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