JERUSALEM--Oramed Pharmaceuticals Inc. (OTCBB:ORMP.OB) (http://www.oramed.com), a developer of oral drug delivery systems, announced today that its subsidiary, Oramed Ltd., has signed an agreement with Medpace, Inc. to retain Medpace as a Clinical Research Organization (CRO) for Oramed's upcoming Phase II clinical trial on its oral insulin capsule, ORMD-0801. The FDA-approved trial will assess the safety and efficacy of Oramed's oral insulin in 147 patients at multiple centers across the United States. Oramed plans to file an Investigative New Drug application (IND) with the FDA in this quarter and commence the trial following approval of the IND.
Medpace is led by top therapeutic and regulatory experts with comprehensive experience in the advancement of pharmaceutical agents for use in multiple therapeutic specialties, and will oversee the entire operation and data management of Oramed's Phase II clinical trial. Dr. David Orloff, Medpace's Vice President of Medical and Regulatory Affairs, is playing a major role in the design and implementation of the upcoming trial. Dr. Orloff is a past director of the FDA's Division of Metabolism and Endocrinology Products and, with Medpace's exemplary standards as a CRO, is well-positioned to advance the most efficient and cost-effective path to drug approval for Oramed.
"We are excited about this collaboration, which represents a significant milestone for the company," commented Nadav Kidron, CEO of Oramed. "After much due diligence, we decided to join forces with the experts at Medpace and look forward to working with them on the FDA-approved clinical trial of our oral insulin capsule."
Medpace was established in 1992, and has partnered with leading pharmaceutical, biotechnology, and medical device companies to bring promising new drugs to market. As a full-service CRO, Medpace combines efficient clinical trial management, comprehensive regulatory consulting, and innovative technologies to create a customized approach that ensures powerful solutions for its partners around the globe.
For more information, please visit Medpace's website at http://www.medpace.com.
About Oramed Pharmaceuticals
Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for drugs and vaccines currently delivered via injection. Established in 2006, Oramed's technology is based on over 25 years of research by top research scientists at Jerusalem's Hadassah Medical Center. Oramed is seeking to revolutionize the treatment of diabetes through its patented flagship product, an orally ingestible insulin capsule currently approaching FDA-approved Phase 2 clinical trials, and with its GLP-1 analog capsule, currently approaching Phase 1b/2a trials, the results of which are expected by the end of the calendar year. The company's corporate and R&D headquarters are based in Jerusalem.
The company's fact sheet can be viewed here.
For more information, the content of which is not part of this press release, please visit http://www.oramed.com.
Forward-looking statements: This press release contains forward-looking statements. For example, we are using forward looking statements when we discuss our FDA approved trial, its expected timing, purpose and Medpace's role in it. 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 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; we may encounter delays or obstacles in launching our clinical trials; our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real settings; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, 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.
Company Contact: Oramed Pharmaceuticals Aviva Sherman Office: +972-2-566-0001 Cell: +972-54-792-4438 Email: [email protected]