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Alpha-1 protein to be tested as treatment for Type 1 diabetes
MarketWire
DENVER, CO—Omni Bio Pharmaceutical, Inc. announced that the Barbara Davis Center for Childhood Diabetes has received regulatory clearance from the U.S. Food and Drug Administration (FDA) to initiate a Phase I and II clinical trial evaluating alpha-1 antitrypsin protein to treat Type I diabetics.
Type 1 diabetes, formerly called juvenile diabetes, is usually diagnosed in children and young adults. In Type 1 diabetes, the pancreas does not produce enough insulin to control blood sugar levels.
The Barbara Davis Center for Childhood Diabetes at the University of Colorado School of Medicine is one of the world’s largest diabetes programs specializing in Type 1 diabetes research and care.
Charles A. Dinarello, acting CEO of OMNI, said, “Although this is the first time AAT (alpha-1 protein) will be evaluated in humans with Type 1 diabetes, AAT already has an excellent safety track record as an FDA-approved biological. We are confident that this outstanding safety profile was a significant factor in the FDA’s IND clearance.”
Alpha-1 antitrypsin protein is the standard augmentation treatment for lung disease due to Alpha-1 Antitrypsin Deficiency (Alpha-1).
Dinarello said preclinical studies demonstrate that AAT may be effective in treating a variety of medical disorders. The decision to pursue a clinical trial of AAT in Type 1 diabetics was based on promising animal study data, he said.
“If AAT’s efficacy in humans is similar to that observed in our animal studies,” said Dinarello, “it could become a method of treatment for qualifying Type 1 diabetics. Despite the prevalence of Type 1 diabetes in the juvenile population, patients and their parents are still waiting for a solution that can stop this debilitating disease in its tracks.”
