LA JOLLA, Calif., Sept. 7, 2011 /PRNewswire/ -- Cebix Incorporated will chair and participate in the symposium, “C-Peptide and the Pathophysiology of Diabetes” on the occasion of the European Association for the Study of Diabetes (EASD) Annual Meeting 2011. Cebix Chief Scientific Officer John Wahren, M.D., Ph.D., and President and CEO James Callaway, Ph.D., along with members of various academic institutions, will present the latest clinical results for C-peptide replacement therapy in complications of diabetes, as well as research uncovering the biological activity of C-peptide and its role in diabetes. The symposium will take place on Monday, September 12, from 1:30 p.m. to 5:30 p.m. WEST in the Atlantic Pavilion at the Lisbon International Fair, Lisbon, Portugal.
Dr. Wahren, who is also Professor Emeritus of Clinical Physiology at the Karolinska Institute in Stockholm, Sweden, and colleagues originally elucidated the physiological role of C-peptide in diabetes. Their research demonstrated that deficiency of C-peptide in diabetes contributes to impaired microvascular function, resulting in progressive damage to the peripheral and autonomic nerves, the kidney and retina. Replacement of native C-peptide was found to exert beneficial effects on the long-term complications of diabetes including peripheral neuropathy and nephropathy.
At the EASD symposium, Dr. Wahren will present clinical data from a study evaluating sexual performance and erectile function in 50 type 1 diabetes patients with peripheral neuropathy treated with native C-peptide. The results show that C-peptide improved erectile function in 46 percent of patients as compared to nine percent of patients receiving placebo.
In Dr. Callaway’s presentation, he will describe the development and characterization of the long-acting form of C-peptide, Ersatta (CBX129801), which has advanced into clinical testing. Preclinical data for the proprietary, mono-pegylated version of C-peptide demonstrated it has improved pharmacokinetic properties, compared to native C-peptide, allowing for once-weekly dosing. Ersatta also improved nerve conduction velocity, a measure of the rate at which electrical signals travel through the nerves, in an animal model of diabetic peripheral neuropathy.
“Cebix and the medical research community have made important progress in increasing our collective knowledge of C-peptide,” said Dr. Wahren. “We look forward to convening at EASD to share our insights and highlight the exciting clinical progress we have all strived for.”
Cebix has established a database of 19 clinical studies evaluating native C-peptide in more than 300 patients with type 1 diabetes. These studies demonstrate that C-peptide replacement therapy improves microvascular circulation and mitigates peripheral and autonomic neuropathy and nephropathy, as well as improves erectile function. The studies provide extensive support of C-peptide as a disease-modifying therapy for serious long-term complications of diabetes. To date, native C-peptide replacement therapy has an excellent safety profile.
Cebix is conducting a Phase 1b clinical trial evaluating Ersatta in patients with type 1 diabetes who, because of their disease, lack this endogenous peptide. Cebix has been granted fast track status for Ersatta in diabetic peripheral neuropathy and the company plans to initiate a pivotal study for this indication in the first half of 2012 as well as a proof-of-concept study in diabetic nephropathy.
Cebix is a sponsor of the C-peptide symposium in collaboration with EASD and the Wenner-Gren Foundations, Sweden.
About C-Peptide in Diabetes
C-peptide is a naturally-occurring peptide that is formed when insulin is cleaved from pro-insulin. In healthy individuals, C-peptide and insulin are co-secreted by the beta cells in the pancreas. Type 1 diabetes is characterized by the body’s inability to produce pro-insulin and consequently both insulin and C-peptide. Because C-peptide deficiency has only recently been implicated in vascular microcirculation dysfunction, treatment today for type 1 diabetes is limited to intensive insulin therapy and frequent blood glucose monitoring to optimize glycemic control. Type 1 and some type 2 diabetic patients have a C-peptide deficiency, which can cause a reduction in microvascular circulation, resulting in progressive damage to the nerves, retina and kidneys.
About Cebix Incorporated
Cebix is developing Ersatta, a C-peptide replacement therapy for the treatment of long-term complications of diabetes. Cebix has been granted fast track status by FDA for Ersatta in the diabetic peripheral neuropathy indication. The company is based in La Jolla, California. For more information, visit www.cebix.com.
SOURCE Cebix Incorporated
