Clinical Results for Oramed’s Oral Diabetes Treatment Published in Peer Reviewed Journal PLOS ONE
Study assessed effectiveness of ORMD-0801 in stabilizing blood sugar levels in unstable Type 1 diabetes patients
Oramed Pharmaceuticals Inc. (ORMP) (http://www.oramed.com), a developer of oral delivery systems of drugs currently administered by injection, announced today that its article titled, “Glucose-reducing effect of the ORMD-0801 oral insulin preparation in patients with uncontrolled Type 1 diabetes: a pilot study,” has been published in PLOS ONE, an international, peer-reviewed, open-access journal which covers primary scientific and medical research.
The article details the results of a clinical study, in which ORMD-0801 was administered to patients with unstable Type 1 diabetes, in conjunction with their regular anti-diabetes treatment regimens. These patients typically suffer from unpredictable and frequent swings in their blood sugar levels, which often demand hospitalization and severely disrupt their quality of life. The addition of ORMD-0801 was well tolerated and significantly stabilized blood sugar levels in this patient group. A significant drop in the frequency of above-normal blood sugar readings was observed, as well as a decrease in overall blood sugar levels throughout the day.
“These published results lay the groundwork for further study of the potential of ORMD-0801 as a treatment that can considerably aid a patient population resistant to standard anti-diabetes treatment protocols,” stated Oramed CEO Nadav Kidron.
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 30 years of research by top research scientists at Jerusalem’s Hadassah Medical Center. Oramed is seeking to revolutionize the treatment of diabetes through its proprietary flagship product, an orally ingestible insulin capsule (ORMD-0801) currently approaching Phase 2 clinical trials under an Investigational New Drug application with the U.S. Food and Drug Administration, and with its oral exenatide capsule (ORMD-0901; a GLP-1 analog), currently approaching Phase 2a trials. The company’s corporate and R&D headquarters are based in Jerusalem.
For more information, the content of which is not part of this press release, please visit http://www.oramed.com.
The company’s fact sheet, the content of which is not part of this press release, can be viewed here.
Forward-looking statements: This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, we are using forward-looking statements when we discuss the potential of ORMD-0810 as a treatment that can considerably aid a patient population resistant to standard anti-diabetes treatment protocols or our oral insulin and oral exenatide candidates approaching Phase 2 clinical trials and 2a clinical trials, respectively. 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 final 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.
Clinical Results for Oramed’s Oral Diabetes Treatment Published in Peer Reviewed Journal PLOS ONE
Study assessed effectiveness of ORMD-0801 in stabilizing blood sugar levels in unstable Type 1 diabetes patients
Oramed Pharmaceuticals Inc. (ORMP) (http://www.oramed.com), a developer of oral delivery systems of drugs currently administered by injection, announced today that its article titled, “Glucose-reducing effect of the ORMD-0801 oral insulin preparation in patients with uncontrolled Type 1 diabetes: a pilot study,” has been published in PLOS ONE, an international, peer-reviewed, open-access journal which covers primary scientific and medical research.
The article details the results of a clinical study, in which ORMD-0801 was administered to patients with unstable Type 1 diabetes, in conjunction with their regular anti-diabetes treatment regimens. These patients typically suffer from unpredictable and frequent swings in their blood sugar levels, which often demand hospitalization and severely disrupt their quality of life. The addition of ORMD-0801 was well tolerated and significantly stabilized blood sugar levels in this patient group. A significant drop in the frequency of above-normal blood sugar readings was observed, as well as a decrease in overall blood sugar levels throughout the day.
“These published results lay the groundwork for further study of the potential of ORMD-0801 as a treatment that can considerably aid a patient population resistant to standard anti-diabetes treatment protocols,” stated Oramed CEO Nadav Kidron.
The article can be viewed on PLOS ONE’s site, the content of which is not part of this press release, at: http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0059524
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 30 years of research by top research scientists at Jerusalem’s Hadassah Medical Center. Oramed is seeking to revolutionize the treatment of diabetes through its proprietary flagship product, an orally ingestible insulin capsule (ORMD-0801) currently approaching Phase 2 clinical trials under an Investigational New Drug application with the U.S. Food and Drug Administration, and with its oral exenatide capsule (ORMD-0901; a GLP-1 analog), currently approaching Phase 2a trials. The company’s corporate and R&D headquarters are based in Jerusalem.
For more information, the content of which is not part of this press release, please visit http://www.oramed.com.
The company’s fact sheet, the content of which is not part of this press release, can be viewed here.
Forward-looking statements: This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, we are using forward-looking statements when we discuss the potential of ORMD-0810 as a treatment that can considerably aid a patient population resistant to standard anti-diabetes treatment protocols or our oral insulin and oral exenatide candidates approaching Phase 2 clinical trials and 2a clinical trials, respectively. 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 final 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.