Published on September 10, 2009 at 2:24 AM
Oramed Pharmaceticals, Inc. (OTCBB: ORMP.OB), a developer of oral drug delivery systems, announced today that it has received approval from the Institutional Review Board (IRB) to commence human clinical trials of an oral GLP-1 Analog. This approval was granted after successful pre-clinical results were reported. The trials will be conducted on healthy volunteers at Hadassah University Medical Center in Jerusalem.
Currently, all GLP-1 Analogs are only available as injections. The oral administration of GLP-1 Analogs may convey physiological advantages for diabetic patients, as the hormone mimics the physiological route of incretin absorption.
GLP-1 Analogs belongs to the Incretin family of drugs which have pleiotropic effects desirable in the management of diabetes. Among the more important effects are the insulinotropic effects and resultant reduction in blood glucose levels, the inhibition of glucagon secretion and the restoration of beta cell mass. GLP-1 Analogs are also associated with weight loss, which is very desirable in patients with diabetes.
"The move from preclinical trials to human clinical trials of ORMD-0901 marks a strategic milestone for the company. We have expanded our platform technology and will now have the opportunity to demonstrate its effectiveness in another important family of polypeptide drugs for diabetes, which is currently only available in injection form," said Oramed CEO Nadav Kidron.
Oramed is currently conducting Phase 2b clinical trials of its flagship product, ORMD-0801, an oral insulin capsule.
http://www.oramed.com