|Oramed Completes Randomization of Over 50% of Patients in Phase IIb Oral Insulin Study|
|Wednesday, 09 September 2015 12:21|
JERUSALEM September 9, 2015 — Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today that 98 patients have already been enrolled in the Company’s Phase IIb study of its oral insulin capsule, ORMD-0801, which represents more than 50% of the 180 patients expected to be recruited for the trial.
The double-blind, randomized Phase IIb study for type 2 diabetes was initiated on June 30th and is designed to generate ample data for both efficacy and safety endpoints.
“We are extremely pleased with the pace of patient enrollment in the trial, which is in line with our expectations. The principal investigators and clinics participating in the trial include some of the most prestigious in the United States,” stated Oramed CEO Nadav Kidron.
About ORMD-0801 Capsule for Type 2 Diabetes
About Oramed Pharmaceuticals
Forward-looking statements: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates” and similar expressions or variations of such words are intended to identify forward-looking statements. For example, we are using forward-looking statements when we discuss our clinical trials, including expected patient enrollment, and revolutionizing the treatment of diabetes with our products. These forward-looking statements are based on the current expectations of the management of Oramed only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the 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 or patent protection for our product candidates; competition from other pharmaceutical or biotechnology companies; and our ability to obtain additional funding required to conduct our research, development and commercialization activities. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; delays or obstacles in launching our clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our process; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from competition; laboratory results that do not translate to equally good results in real settings; our patents may not be sufficient; and finally that products may harm recipients, all of which could cause the actual results or performance of Oramed to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Oramed undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Oramed, reference is made to Oramed's reports filed from time to time with the Securities and Exchange Commission.