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): June 29, 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 June
28, 2010, Oramed Pharmaceuticals Inc. issued a press release announcing that its
executive management is participating in the 2010 Scientific Sessions of the
American Diabetes Association currently being held in Orlando,
Florida. Dr. Miriam Kidron, Chief Scientific Officer, is scheduled to
present results of two of the company’s recently completed clinical trials
between 12:00 – 2:00 PM ET on Monday, June 28, 2010 in Poster Hall C at the
Orange County Convention Center.
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)
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Exhibits
|
|
Exhibit
Number
|
Description
|
|
|
99.1
|
Press
Release dated June 28, 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.
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|||
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Dated:
June 29, 2010
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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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|||
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President,
CEO and
Director
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|||
Exhibit
Index
|
Exhibit
Number
|
Description
|
|
|
99.1
|
Press
Release dated June 28, 2010.
|
Oramed
Pharmaceuticals to present at the 70th
Scientific Sessions of
the
American Diabetes Association
Results
of first exposure of Type I diabetes patients to Oramed’s oral insulin and of a
first-in-humans study with its oral GLP-1 analog
Jerusalem,
IL - June 28, 2010 - Oramed Pharmaceuticals Inc. (OTCBB: ORMP) announced today
that its executive management is participating in the 2010 Scientific Sessions
of the American Diabetes Association currently being held in Orlando,
Florida. Dr. Miriam Kidron, Chief Scientific Officer, is scheduled to
present results of two of the company’s recently completed clinical trials
between 12:00 – 2:00 PM ET on Monday, June 28, 2010 in Poster Hall C at the
Orange County Convention Center.
One
presentation will provide an overview of the results of a Phase IIa study
testing the company’s flagship ORMD-0801 oral insulin capsule in Type I diabetes
patients when administered just before (10-90 minutes) a standard
meal. This first exposure of Oramed’s oral insulin established the
drug’s safety and efficacy in Type I diabetics. ORMD-0801 led to a
significant increase in insulin levels in 61% of the treatment sessions,
irrespective of the time lapse between ORMD-0801 administration and
mealtime. The oral insulin preparation effectively kept glucose
levels in check in all sessions. These data suggest both tolerance of
Oramed’s platform to preprandial dosing regimens and its therapeutic potential
in regulating Type I diabetes.
In
addition, Dr. Kidron will present a summary of Oramed’s first-in-humans clinical
trial testing the safety and efficacy of ORMD-0901, an encapsulated oral GLP-1
analog formulation. The study monitored the responses of healthy
males to a single dose delivered 60 minutes before a glucose
load. ORMD-0901 was well tolerated by all subjects and demonstrated
physiological activity, as extrapolated from ensuing subject insulin levels when
compared to those observed after treatment with placebo.
The
poster entitled “Oral Insulin: Type I Diabetes (T1DM) Patient Response Upon
Preprandial Administration” will be featured in a guided tour in the Poster
Hall. The tour title is "Innovations in Novel Insulin Preparations" and is
scheduled for Monday June 28 at 12:00-1:00 PM.
To view
the posters being presented, please visit: www.oramed.com
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's corporate and R&D headquarters are based in
Jerusalem.
For more
information, please visit http://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 Inc.
Tara
Horn
Office:
646-240-4193
Cell:
+972-54-334-4318
Email:
tara@oramed.com