Diabetic Neuropathy

Phase 2 trial data presented during the 63rd Scientific Sessions of the American Diabetes Association showed that patients with diabetic peripheral neuropathy treated with ruboxistaurin mesylate (Eli Lilly and Company, Indianapolis, IN) showed improvement in Clinical Global Impression (CGI)-a globally accepted assessment tool used to measure patient's overall well-being. CGI ratings showed the greatest correlation with improvement in patient symptoms.

Diabetic peripheral neuropathy is associated with underlying microvascular damage that affects nerves outside the brain and spinal cord, potentially leading to foot ulcers and amputations. Preclinical data show that ruboxistaurin is a specific inhibitor of PKC [latin sharp s], an enzyme implicated in the underlying process of microvascular damage.

Patients with type 1 or 2 diabetes with diabetic peripheral neuropathy were randomized to receive 32 mg or 64 mg of ruboxistaurin or placebo. In the 1-year trial, treatment with ruboxistaurin mesylate improved diabetic peripheral neuropathy symptoms as assessed by Neuropathy Total Symptom Score-6, a measure that evaluates symptom frequency and intensity. Treatment led to clinically significant improvements in CGI ratings.

Ongoing studies are investigating ruboxistaurin as a possible treatment for diabetic peripheral neuropathy, diabetic retinopathy, and diabetic nephropathy, the 3 major diabetic microvascular complications.

[black up pointing small triangle]Information:http://www.lilly.com

Gene Therapy

The University of California, San Diego, in San Diego, CA, is recruiting patients for a study to evaluate a new way to deliver gene therapy to wound tissue in patients with diabetes. Gene therapy with the platelet-derived growth factor-B gene (PDGF-B) has been shown to help heal chronic wounds. Because patients with diabetes may develop chronic wounds that respond poorly to treatment, they may benefit from gene therapy. PDGF-B has been approved for use in diabetic ulcers, but delivery and maintenance of sufficient drug quantities at the wound site for sustained periods hampers its widespread use.

This study will evaluate the safety and potential clinical utility of topical applications of GAM501, a gene for PDGF-B that is formulated into a collagen gel. This formulation allows the migration of wound repair cells into the structural matrix, where they subsequently produce therapeutic protein within the local wound environment.

To be eligible for the study, participants must be age 18 or older and meet specific enrollment criteria.

[black up pointing small triangle]Information:http://www.clinicaltrials.gov/ct/show/NCT00065663