Oramed Pharmaceuticals Reports Last Patient Out in Phase IIa Trial for ORMD-0801 in Type 1 Diabete
- Category: Proteins and Peptides
- Published on Thursday, 07 August 2014 17:07
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JERUSALEM, Isarel I August 7, 2014 I Oramed Pharmaceuticals Inc. (NASDAQ: ORMP) (http://www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, today reports that the last patient has completed treatment in its Phase IIa clinical trial of ORMD-0801, the Company's proprietary oral insulin capsule, to treat type 1 diabetes, and top-line data is expected to be reported in the fourth quarter of 2014. The trial was conducted in the United States under a Food and Drug Administration Investigational New Drug protocol.
The prospective, randomized, double-blind, placebo controlled study in patients with established type 1 diabetes is evaluating the safety and impact of ORMD-0801 on the exogenous insulin requirements in 24 type 1 diabetics patients.
About Type 1 Diabetes
Type 1 diabetes is an autoimmune disease in which the pancreatic beta cells responsible for insulin secretion are attacked by the immune system. In the absence of self-produced insulin and the concomitant glycemic control, there is a need to supply extraneous insulin in order to regain glycemic control and prevent future disease complications that include heart disease, blood vessels disease, nerve and eye disease, infections, hypoglycemic events and many more ailments. According to the International Diabetes Federation, type 1 diabetes is on the rise at a rate of 3% per year and currently affects approximately 36 million people worldwide - about 10% of the global diabetes population. The disease was formerly known as juvenile diabetes, and currently affects both pediatric and adult populations.
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 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), having completed separate Phase IIa clinical trials, and anticipating 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, and with its oral GLP-1 analog capsule (ORMD-0901). For more information, the content of which is not part of this press release, please visit: http://www.oramed.com.
SOURCE: Oramed Pharmaceuticals