Full Press Release Details
Pharmaceuticals Partners with ETI Karle Clinical to
2B Trials on Its Oral Insulin Capsule, ORMD 0801
to be tested on Type 2 Diabetic Volunteers
Israel - September 9, 2008 - Oramed Pharmaceuticals, Inc. (OTCBB: ORMP.OB;
developer of oral delivery systems, announced today the signing of an agreement
with ETI Karle Clinical Pvt. Ltd. (www.etiklinical.com),
clinical research organization (CRO) located in India, to conduct Phase 2B
clinical trials on its oral insulin capsules.
is intended to evaluate the safety, tolerability and efficacy of ORMD 0801,
Oramed's oral insulin capsule, on diabetic type 2 patients.
anticipated that the Phase 2B study will be conducted over several months
starting in the first quarter of 2009, with approximately 60
subjects participating
has been able to demonstrate that ORMD 0801 has a good safety profile and
effective on a small group of diabetes patients. This trial is intended to
affirm that ORMD 0801 will perform to our expectation on a large group of type
diabetes patients," said Nadav Kidron, CEO of Oramed.
Clinical Pvt. Ltd is a Pan-Asian CRO, headquartered in Bangalore with a network
of 60 clinical trial sites across all therapeutic areas, with access to 2
million patients, and 120 researchers.
Oramed Pharmaceuticals
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.
more information, please visit www.oramed.com
the statements contained in this press release are forward-looking statements
which involve known and unknown risks, uncertainties and other factors which
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.
and Investor Relation Contacts:
Finn Israel for Oramed
Karle Clinical Pvt. Ltd.
Block, Rajaji Nagar,