Alteon Inc. announced today that it has dosed its first patient in a 60-patient Phase 2 clinical trial (Study 201) of ALT-2074, its lead glutathione peroxidase mimetic, in diabetic patients with a variant of haptoglobin that renders them at high risk for cardiovascular complications.
This dose escalating study is designed to evaluate ALT-2074's ability to lower inflammatory cardiovascular biomarkers in patients with an elevated risk for cardiovascular events.
It builds on positive data from previous cardiovascular animal studies. ALT- 2074's activity in prior clinical trials demonstrated its safety and ability to lower inflammatory markers in ulcerative colitis.
'The initiation of Study 201 is a key milestone in our program for the development of ALT-2074 as a treatment for diabetic patients with a high risk of cardiovascular events,'said Malcolm W. MacNab, M.D., Ph.D., Alteon's Vice President, Clinical Development.
'We are enthusiastic about the potential that ALT-2074 has demonstrated in our preclinical models and we are aggressively pursuing clinical development in this indication.'
Diabetes and Metabolic Syndrome, diseases linked to obesity and increased oxidative stress, are growing in epidemic proportions in the United States and many other developed countries.
The major complications associated with these diseases are cardiovascular in nature, and lead to such events as stroke, heart attack, kidney failure and death. Not all patients with diabetes, however, experience these complications.
Several multinational studies have demonstrated that the increased risk of cardiovascular disease attributed to diabetes is more aptly attributed to the development of diabetes 'on top of' a predisposing genetic factor called Haptoglobin 2-2 (Hp2-2), which is found in 40% of the human population.
The combination of diabetes and Hp2-2 increases the susceptibil
ity of patients to a defect in their cholesterol metabolism, which may promote atherosclerosis, and to a weakness in their antioxidant defense, so essential to the human body when oxygen is less available (during a heart attack for example).
Targeting a potent antioxidant drug candidate like ALT-2074 to these high risk patients is an example of targeted therapy. By redefining diabetes, Alteon believes that it can advance an efficient clinical development program in which a more appropriately targeted therapy is given to a more susceptible patient population.
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