"Oramed Pharmaceuticals Inc. NASDAQ ORMP httpstudio.financialcontent.comprnewsPageQuoteTickerORMP today announced positive topline results from its Phase IIb study designed to evaluate the safety and efficacy of its oral insulin capsule ORMD in patients with type  diabetes. The studys primary objective a significant reduction of weighted mean nighttime glucose was successfully achieved. This demonstration of safe and effective oral insulin delivery represents a transformative event in the treatment of type  diabetes said Nadav Kidron Oramed CEO. We are delighted with the results and look forward to moving into Phase III trials. This US based double blind  day randomized study of  adult type  diabetic patients showed a statistically significant decrease in the primary endpoint pooled nighttime glucose mean percentage change of . from runin between placebo and active cohorts p.. The study additionally demonstrated a good safety profile with no drug related serious adverse events. These are very impressive results that confirm the efficacy of orally delivered intestinally absorbed insulin said Dr. Michael Berelowitz Head of Orameds Scientific Advisory Board. The promise of this more physiological delivery system for insulin is the inhibition of hepatic glucose production which was clearly demonstrated via the significant reduction in nighttime glucose levels in patients who received ORMD. The Company plans to present and publish more comprehensive data in the future. Conference Call today May  at  am Eastern Time   Oramed will host a conference call to discuss the study results. Interested parties may access the call at  US or  UK. Conference ID  About the Phase IIb Oral Insulin Study  The doubleblind randomized Phase IIb study of  patients with type  diabetes was initiated on June   and was conducted at  clinical sites in the United States under an IND that was approved by the FDA. The study was designed to generate data to assess the safety and efficacy of multiple oral bedtime doses of ORMD in adult patients with type  diabetes mellitus who are inadequately controlled with diet and metformin. The study was comprised of three arms placebo ORMD mg and ORMD  mg.  Patients were dosed before bedtime and their nighttime glucose levels  hours post dose were continuously monitored. For more information on the study which does not form a part of this press release see httpsclinicaltrials.govctshowNCTtermoramedrank About ORMD  ORMD has the potential to create a new paradigm in the treatment of diabetes by oral delivery of insulin at an earlier stage of treatment potentially slowing disease progression and delaying or even eliminating latestage complications. Orally administered insulin is expected to enhance patient compliance. In addition intestinally absorbedoral insulin mimics insulins natural location and gradients in the body by first passing through the liver before entering the bloodstream. About Oramed Pharmaceuticals  Oramed Pharmaceuticals is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in  Orameds Protein Oral Delivery PODTM technology is based on over  years of research by scientists at Jerusalems Hadassah Medical Center. Oramed is seeking to revolutionize the treatment of diabetes through its proprietary flagship product an orally ingestible insulin capsule ORMD http  The Company completed multiple Phase II clinical trials under an Investigational New Drug application with the U.S. Food and Drug Administration. In addition Oramed is developing an oral GLP analog capsule ORMD http For more information the content of which is not part of this press release please visithttp Forwardlooking statements  This press release contains forwardlooking statements within the meaning of the Private Securities Litigation Reform Act of  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 forwardlooking statements. For example we are using forwardlooking statements when we discuss our Phase IIb study that the demonstration of safe and effective oral insulin delivery represents a transforming event in the treatment of type  diabetes when we discuss moving into Phase III trials when we discuss ORMD and its potential to create a new paradigm in the treatment of diabetes by oral delivery of insulin or when we discuss revolutionizing the treatment of diabetes with our products. These forwardlooking 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 forwardlooking 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 forwardlooking 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 forwardlooking statements. Except as otherwise required by law Oramed undertakes no obligation to publicly release any revisions to these forwardlooking 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 Orameds reports filed from time to time with the Securities and Exchange Commission."