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Cebix Incorporated's Long-Acting C-Peptide Ersatta™ has Potential in Multiple Chronic Complications of Diabetes


6/27/2011 6:21:00 AM

LA JOLLA, Calif., June 24, 2011 /PRNewswire/ -- Cebix Incorporated announced today that preclinical data for its long-acting form of C-peptide, Ersatta(CBX129801), demonstrated a half-life of three days as compared to one hour for native C-peptide. Ersatta halted the impairment in nerve conduction velocity, a measure of the rate at which electrical signals travel through the nerves, in an animal model of diabetic peripheral neuropathy. Additionally, clinical data showed that native C-peptide replacement therapy improved erectile function in 46% of type 1 diabetes patients as compared to 9% of patients receiving placebo. These preclinical and clinical data will be presented in two posters at the 71st Annual Meeting of the American Diabetes Association in San Diego starting on Saturday, June 25.

"C-peptide replacement therapy is a clinically-validated approach to treating multiple serious long-term complications of diabetes, including erectile dysfunction, peripheral neuropathy, and nephropathy," said John Wahren, M.D., Ph.D., Chief Scientific Officer of Cebix. "We see tremendous potential in Ersatta to treat all of these diseases, because its biological activity is comparable to that seen in the native peptide, and the long-acting form will require less frequent dosing, thereby improving patient convenience and compliance."

Cebix has an established 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 increases nerve blood flow and mitigates peripheral and autonomic neuropathy and nephropathy, as well as improves erectile function. To date, native C-peptide replacement therapy has an excellent safety profile.

Sheri Barrack, Ph.D., Senior Vice President, Pharmaceutical Development of Cebix, will present the background of C-peptide therapy and the preclinical studies of Ersatta in a poster entitled "Development of a Long-acting C-peptide" (Abstract 1049-P) at 11:30 am - 1:30 pm on Saturday, June 25. The central focus of this poster is the development and characterization of the long-acting form of C-peptide that has advanced into clinical testing. In a separate poster entitled "C-Peptide Improves Erectile Function in Type 1 Diabetes" (Abstract 1039-P) also at 11:30 am - 1:30 pm on Saturday, June 25, clinical data from a study evaluating sexual performance and erectile function in 50 type 1 diabetes patients with peripheral neuropathy will be presented by Dr. Wahren. Both posters will be on display at the conference from 10:00 am on Saturday, June 25, until 4:00 pm on Monday, June 27, in the exhibit hall at the San Diego Convention Center.

Ersatta is currently being evaluated in a Phase 1b clinical trial in type 1 diabetes patients. Cebix has defined the pathway to marketing approval for Ersatta under U.S. Food and Drug Administration (FDA) subpart H. Cebix has been granted fast track status by FDA for Ersatta in diabetic peripheral neuropathy, and the company plans to initiate a pivotal Phase 2/3 trial for this indication in the first half of 2012.

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. Researchers initially concluded that C-peptide was merely a by-product of the excision of insulin from the larger pro-insulin molecule, but Dr. Wahren demonstrated it to be a bioactive peptide in its own right, contributing to the preservation of microvascular health of multiple organ types.

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. The company is based in La Jolla, California. For more information, visit www.cebix.com.

SOURCE Cebix Incorporated



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