Glucose Clamp Study is Expected to Complement Oramed’s Planned Phase IIb Study
JERUSALEM, Israel I April 1, 2015 I Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (http://www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today the first patient has been enrolled in its Glucose Clamp Study. The study will be performed at The University of Texas Health Science Center at San Antonio and University Health System’s Texas Diabetes Institute under the supervision of Professor Ralph DeFronzo.
The glucose clamp is a method for quantifying insulin absorption in order to measure a patient’s insulin sensitivity and how well a patient metabolizes glucose. The glucose clamp technique represents the gold standard for pharmacodynamic studies in diabetes drug development.
In addition to the clamp study, Oramed plans to initiate its Phase IIb oral insulin trial in the U.S. with a protocol which includes over 30 U.S. sites covering approximately 180 patients and has both efficacy and safety as its primary end-points.
“We are pleased to have initiated this study and enrolled the first patient. We are additionally excited at the prospects of starting our larger Phase IIb trial in the near term. The data from the two trials will allow for a clearer picture of our oral insulin and its pharmacological characteristics as we move forward with our development plan,” stated Oramed CEO Nadav Kidron.
About Oramed Pharmaceuticals
Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, Oramed’s Protein Oral Delivery (POD[TM]) technology is based on over 30 years of research by top 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). Having completed separate Phase IIa clinical trials, the company anticipates the initiation of separate Phase IIb clinical trials, in patients with both type 1 and type 2 diabetes under an Investigational New Drug application with the U.S. Food and Drug Administration. In addition the company is developing an oral GLP-1 analog capsule (ORMD-0901).
SOURCE: Oramed Pharmaceuticals
Post Views: 22
Glucose Clamp Study is Expected to Complement Oramed’s Planned Phase IIb Study
JERUSALEM, Israel I April 1, 2015 I Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (http://www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced today the first patient has been enrolled in its Glucose Clamp Study. The study will be performed at The University of Texas Health Science Center at San Antonio and University Health System’s Texas Diabetes Institute under the supervision of Professor Ralph DeFronzo.
The glucose clamp is a method for quantifying insulin absorption in order to measure a patient’s insulin sensitivity and how well a patient metabolizes glucose. The glucose clamp technique represents the gold standard for pharmacodynamic studies in diabetes drug development.
In addition to the clamp study, Oramed plans to initiate its Phase IIb oral insulin trial in the U.S. with a protocol which includes over 30 U.S. sites covering approximately 180 patients and has both efficacy and safety as its primary end-points.
“We are pleased to have initiated this study and enrolled the first patient. We are additionally excited at the prospects of starting our larger Phase IIb trial in the near term. The data from the two trials will allow for a clearer picture of our oral insulin and its pharmacological characteristics as we move forward with our development plan,” stated Oramed CEO Nadav Kidron.
About Oramed Pharmaceuticals
Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, Oramed’s Protein Oral Delivery (POD[TM]) technology is based on over 30 years of research by top 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). Having completed separate Phase IIa clinical trials, the company anticipates the initiation of separate Phase IIb clinical trials, in patients with both type 1 and type 2 diabetes under an Investigational New Drug application with the U.S. Food and Drug Administration. In addition the company is developing an oral GLP-1 analog capsule (ORMD-0901).
SOURCE: Oramed Pharmaceuticals
Post Views: 22
