JERUSALEM, April 28, 2015 /PRNewswire/ —
Oramed Pharmaceuticals Inc. (ORMP) (http://www.oramed.com)
Dear Friends, Shareholders and Associates,
I am very excited to announce that we are on the threshold of initiating our much-awaited Phase IIb clinical trial for oral insulin (ORMD-0801) and the treatment of type 2 diabetes. Our goal is to commence the trial in the coming weeks. This clinical trial will be our largest and most comprehensive study to date and marks a significant milestone for the company, literally putting us in a different place.
The Phase IIb study will build directly on the success of our two Phase IIa studies which were completed in 2014. This study will be significantly larger in scope and design than the prior studies so as to demonstrate both efficacy and safety as primary endpoints.
I am happy to share, that the study has already received Institutional Review Board (IRB) approval and we plan on submitting the study’s protocol to the Federal Drug Administration (FDA) in the coming month of May, which will be followed soon thereafter by study enrolment. We are positioned for an efficient recruitment process, having successfully recruited over 30 clinical sites, which include some of the most prestigious clinics and investigators in the United States.
We look forward to embarking on this important next step and, as usual, we will keep you abreast as this study progresses.
Sincerely,
Nadav Kidron, CEO
