Stanford University, OHSU receive grants to study VIAject for treating patients with diabetes

Biodel Inc.Jul 12 2010

Biodel Inc. (Nasdaq: BIOD) announced today the award of two research grants by the Juvenile Diabetes Research Foundation (www.jdrf.org) to Stanford University and Oregon Health & Science University (OHSU) to evaluate the use of VIAject® (ultra-rapid-acting injectable human insulin) in the treatment of diabetes.  The first grant will support clinical testing under the direction of Bruce Buckingham, M.D., professor of pediatrics at Stanford University School of Medicine, to compare the effects of VIAject® and Humalog® (insulin lispro) on postprandial glycemia when used with insulin pumps.  The second grant will support clinical testing at OHSU under the direction of W. Kenneth Ward, M.D., associate professor at OHSU, to evaluate the use of VIAject® to improve closed-loop, (artificial pancreas) glycemic control in patients with Type 1 diabetes.  Biodel will supply VIAject® to these institutions which will receive a total of approximately $407,000 from JDRF to fund the two research projects over the next year.

Dr. Alan Krasner, Biodel's chief medical officer, stated: "The goal of these projects is to evaluate whether an ultra-rapid-acting insulin can safely improve glycemic control for Type 1 patients and do so with less direct medical supervision.  We are pleased to be working with leading endocrinologists at Stanford and OHSU on this research and thank JDRF for its support of these important studies."  

Dr. Ward stated: "Despite advances in insulin delivery and formulation, currently available insulins do not adequately mimic the first-phase insulin release needed to provide proper meal-time glycemic control for patients with Type 1 diabetes.  We look forward to evaluating Biodel's more-rapid-acting injectable human insulin in a closed-loop setting to see whether we can achieve better post-prandial glycemic control for these patients."

VIAject® is Biodel's proprietary ultra-rapid-acting formulation of recombinant human insulin that is designed to be absorbed into the blood faster than currently marketed rapid-acting insulin analogs.  It has been tested in more than 875 patients who participated in Phase 1, 2 and 3 clinical trials of the drug in the United States, Germany and India.  Biodel has submitted an application to the U.S. Food and Drug Administration for clearance to market VIAject® for the treatment of diabetes.