AtheroGenics Announces First Patients Enrolled in ANDES Phase III Diabetes Clinical Trial
biz.yahoo.com
Thursday August 23, 8:44 am ET
ATLANTA, GA--(MARKET WIRE)--Aug 23, 2007 -- AtheroGenics, Inc. (NasdaqGM:AGIX - News), a pharmaceutical company focused on the treatment of chronic inflammatory diseases, today announced enrollment of the first patients in ANDES (AGI-1067 as a Novel Anti-Diabetic Agent Evaluation Study). ANDES is a Phase III clinical trial of AGI-1067, an investigational first-in-class oral anti-diabetic agent with anti-inflammatory and antioxidant properties.
"We have successfully executed an on-time start for this Phase III study. ANDES is designed to confirm the extensive data that we saw in ARISE, our long term Phase III outcomes trial, demonstrating the ability of AGI-1067 to improve diabetic control," said Rob Scott, M.D., Executive Vice President of Research & Development and Chief Medical Officer at AtheroGenics."
"Diabetes has become one of the major health problems facing both physicians and patients today. Statistics show that the majority of the 14 million Americans who are currently diagnosed with diabetes are failing to reach accepted standards of blood sugar control. We desperately need new diabetes therapeutic options that have demonstrated overall cardiovascular safety," remarked Sherwyn Schwartz, M.D., Chief Executive Officer and Chief Medical Officer of DGD Research, and lead U.S. investigator for ANDES. "ANDES is an important study that could verify the potential therapeutic benefit of AGI-1067 in the control of blood sugar levels and perhaps provide us with another tool to treat this complicated disease."
ANDES is a double-blind, placebo controlled study being conducted at sites in the United States, South Africa, Eastern Europe and India. The trial is designed to randomly assign approximately 1,200 patients with confirmed type II diabetes mellitus to one of three doses of AGI-1067 (75, 150, and 300 mg) or placebo for 25 weeks. All patients enrolled in the trial will be on one or no anti-diabetic medication. The key objective of ANDES is to compare the effects three doses of AGI-1067 versus placebo on glycemic endpoints. AtheroGenics is planning to conduct an interim analysis in mid-2008, and the study is expected to conclude before the end of 2008.
About AGI-1067
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