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Cebix Initiates Phase 1b Clinical Trial with Drug Candidate Ersatta™
Date:6/16/2011

LA JOLLA, Calif., June 16, 2011 /PRNewswire/ -- Cebix Incorporated announced today it is advancing the development of modified C-peptide for the treatment of complications of diabetes. The biopharmaceutical company has initiated a Phase 1b clinical trial to evaluate Ersatta™, its proprietary long-acting form of C-peptide, in patients with type 1 diabetes who, because of their disease, lack this endogenous peptide.  Following the successful completion of this study, the company is planning a mid-stage clinical program in diabetic peripheral neuropathy and other chronic conditions associated with diabetes that may be reversed by replacing C-peptide.

The primary objectives of the randomized, blinded, placebo-controlled Phase 1b study are to assess the safety, tolerability as well as single and multiple dose pharmacokinetics of Ersatta after subcutaneous administration.  The study is estimated to enroll 30-60 patients and will be conducted at up to six sites in the U.S.  

Ersatta, a proprietary, mono-pegylated version of C-peptide, has improved pharmacokinetic properties compared to the native peptide. Pegylation of C-peptide extends the drug half-life, allowing for once-weekly dosing, which enhances patient compliance. Ersatta has been shown to improve nerve function in preclinical studies in a rat diabetic neuropathy model. Cebix has defined the pathway to marketing approval for Ersatta under U.S. Food and Drug Administration (FDA) subpart H. Nerve conduction velocity will therefore be the sole primary endpoint for a Phase 2/3 pivotal trial in diabetic peripheral neuropathy, which Cebix plans to initiate in the first half of 2012. Cebix has been granted fast track status by FDA for Ersatta in the diabetic peripheral neuropathy indication.

To date, Cebix has raised $30.5 million in Series A financing and established a database of 19 clinical studies evaluating native C-peptide in more than 300 patients with ty
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SOURCE Cebix Incorporated
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