Navigation Links
Oramed Pharmaceuticals Reports Results in Phase 2b Trial of Oral Insulin Administration to Type 2 Diabetes Patients
Date:5/6/2010

JERUSALEM, Israel, May 6, 2010 /PRNewswire-FirstCall/ -- Oramed Pharmaceuticals Inc. (OTCBB: ORMP), a developer of alternative drug delivery systems, reported today results for the recently completed Phase 2b non-FDA clinical trial of its flagship oral insulin capsule, ORMD-0801.

The randomized, double-blind, placebo-controlled, multi-centered study conducted in South Africa evaluated responses of 29 Type 2 diabetes patients to ORMD-0801. Insulin-loaded or placebo capsules were administered to patients, who were closely monitored throughout the 6-week study period. Safety, tolerability and efficacy parameters of Oramed's oral insulin were assessed.

ORMD-0801 was found to be well tolerated and exhibited a positive safety profile. No cumulative adverse effects were reported throughout this first study of extended exposure to ORMD-0801. In addition, the percentage of subjects demonstrating clinically relevant reductions in insulin, c-peptide, fasting blood glucose and Hb1Ac levels was always higher in the ORMD-0801 cohort, when compared to the placebo. Moreover, mean decreases in insulin and CRP levels were found to be statistically significant following the 6-week, once-daily ORMD-0801 treatment period. These findings suggest that ORMD-0801 attenuates insulin oversecretion, reprieving beta cells from their heightened activity. The reported results substantiate the safety and tolerability of ORMD-0801 and demonstrate that oral insulin has a relevant clinical impact at the tested dose. The data collected from this trial will help to further the development of ORMD-0801 in future, pivotal trials.

Harold Jacob, M.D., a member of the Oramed Board of Directors, said, "the results of this trial once again underscore the safety of Oramed's oral insulin preparation. These results show a positive trend of efficacy for the tested oral insulin preparation." Nadav Kidron, Chief Executive Officer of Oramed Pharmaceuticals, added "this study, as well as data from our earlier studies, suggests that Oramed's technology is an effective and well-tolerated delivery platform that will potentially make a significant clinical impact on diabetes management. We are proceeding with confidence toward IND approval in the United States."

For more information about Oramed's clinical development programs, please visit http://www.oramed.com.

Safe Harbor Statement

Some of the statements contained in this press release are forward-looking statements which involve known and unknown risks, uncertainties and other factors which may 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.

    Company and Investor Relation Contacts:

    Oramed Pharmaceuticals
    Tara Horn
    Office: +1-646-240-4193
    Cell: +972-54-334-318
    Email: tara@oramed.com



'/>"/>
SOURCE Oramed Pharmaceuticals Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. Israels Prestigious Presidents Conference to Feature Oramed Pharmaceuticals Revolutionary Oral Insulin Capsule
2. Oramed Pharmaceuticals to Present Oral Insulin Trial Results at ADA Conference (June 6-10, San Francisco)
3. Oramed Pharmaceuticals Partners With ETI Karle Clinical to Conduct Phase 2B Trials on Its Oral Insulin Capsule, ORMD 0801
4. Oramed Pharmaceuticals to Present at Rodman & Renshaw Healthcare Conference (November 11, 2008; NYC)
5. Oramed Pharmaceuticals Reports Positive Results From a Study of Oral Insulin Capsule on Type 1 Diabetic Patients
6. Oramed Pharmaceuticals was Awarded a NIS 3.1 Million Grant From the Israeli Office of the Chief Scientist
7. Frost and Sullivan Honors Oramed Pharmaceuticals With the 2009 European Oral Drug Delivery Technology Innovation Award
8. Oramed Pharmaceuticals to Present at Rodman & Renshaw 11th Annual Healthcare Conference
9. Oramed Pharmaceuticals Commences Human Clinical Trials of an Oral GLP-1 Analog
10. Orameds Chief Scientific Officer, Miriam Kidron, Ph.D., Chosen to Lecture at the Third International Conference on Advanced Technologies and Treatments for Diabetes in Basel, Switzerland
11. Vion Pharmaceuticals Pays Interest on 7.75% Convertible Senior Notes
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/26/2016)... ... May 26, 2016 , ... After several promising treatments in ... the City of Knowledge in Panama, a 6 year-old Duchenne’s muscular dystrophy patient ... this year following FDA approval of a second application for a single patient, ...
(Date:5/25/2016)... ... 2016 , ... Thailand’s Board of Investment’s New York office, ... Located at booth number 7301, representatives from the Thai Government, research organizations, and ... biotechnology and life sciences sector. , Deputy Secretary General of the Thailand ...
(Date:5/25/2016)... (PRWEB) , ... May 25, 2016 , ... Scientists at ... line options being tried for mesothelioma may be hampering the research that could lead ... research. Click here to read it now. , The team evaluated 98 ...
(Date:5/24/2016)... ... May 24, 2016 , ... Cell ... injuries, will be accelerated by research at Worcester Polytechnic Institute (WPI) that yielded ... healing and tissue regeneration. , The novel method, developed by WPI faculty members ...
Breaking Biology Technology:
(Date:3/15/2016)... New York , March 15, 2016 ... new market report published by Transparency Market Research "Digital Door ... Trends and Forecast 2015 - 2023," the global digital door ... US$ 731.9 Mn in 2014 and is forecast to grow ... 2023. Growth of micro, small and medium enterprises (MSMEs) across ...
(Date:3/11/2016)... 11, 2016 http://www.apimages.com ) - --> ... is available at AP Images ( http://www.apimages.com ) - ... used to produce the new refugee identity cards. DERMALOG will be ... CeBIT in Hanover next week.   --> ... be used to produce the new refugee identity cards. DERMALOG will ...
(Date:3/9/2016)... YORK , March 9, 2016 This ... and future states of the RNA Sequencing (RNA Seq) ... segments such as instruments, tools and reagents, data analysis, ... Analyze various segments of the RNA-Sequencing market such as ... services Identify the main factors affecting each segment and ...
Breaking Biology News(10 mins):