Circumstances of confusion invalidated a Diamyd clinical trial to protect insulin-producing cells in diabetes patients. This confusion amounts to a speed bump, but Diamyd intends to press on.

The company admitted that the Phase II clinical trial of its gene therapy had been botched following a mix up over which patients received the drug and which got placebo. Diamyd is a vaccine based on GAD65, a major factor for diabetes due to an autoimmune reaction. The company designed the vaccine to reduce the need of insulin injections and prevent the destruction of beta cells that produce insulin in the pancreas. Also, by protecting these cells, it may allow them to regenerate in a non-autoimmune environment, and possibly set the stage for a cure of the disease.

Anders Essen-Möller, CEO of Diamyd, said: "Was the drug mixed up? We do not know. Could there be a mix-up at some other times in the study? Yes it is possible, but that is not certain." Essen-Möller is determined not to let the mistake ruin the vaccine's progress towards approval. Essen-Möller also said he believes that the invalidation of the trial will not adversely affect any ongoing meetings with potential partners.

A report published in Diabetes Care says C-peptide improves sensory nerve function in type 1 diabetic patients with early-stage diabetic neuropathy. Thanks to Scott Strumello's comment, earlier today, I couldn't help but query the world wide web for more information on this C-peptide revelation. If I forget to mention it - thanks a million, Scott!

C-peptide was shown to be a significant factor in the maintenance of microvascular function. In a 6 month study of type 1 diabetes patients receiving replacement C-peptide, their nerve functions improved remarkably. A randomized study of 139 patients received one of 3 daily treatments: 1.5 mg of C-peptide, 4.5 mg of C-peptide, or placebo. At the beginning of the study, the sensory and motor nerve conduction velocities were significantly reduced compared with normal. After 6 months of treatment, peak sensory nerve conduction velocities improved in the groups treated with low-dose or high-dose C-peptide, but not significantly compared with the control group. The study showed a significant advantage in nerve functions for those treated with C-peptide (37%) verses those in the control group (19%). Overall, there were no adverse drug reactions reported from treatment of C-peptide.

At this time, there is strong evidence supporting the belief that C-peptide may be beneficial not only for nerve function, but also for the treatment and prevention of other long-term complications caused by type 1 diabetes such as nephropathy and perhaps retinopathy. Phase II clinical studies are ongoing at this time to demonstrate the safety and efficacy of C-peptide replacement therapy for the treatment of diabetic peripheral neuropathy. I can hear the trumpets playing already. I'll be right there with pen-in-hand ready to sign the dotted line for such a study. Thank you, Scott and thank you, Creative Peptides.