BEER-SHEVA, ISRAEL, June 29, 2010 - The U.S. Food & Drug Administration (FDA) has granted Investigational New Drug (IND) regulatory clearance to initiate a Phase I/II clinical trial evaluating Alpha-1 Antitrypsin (AAT) in type 1 diabetics, based on research by Dr. Eli Lewis of Israel's Ben-Gurion University of the Negev.
This is the first time AAT will be evaluated in humans with type 1 diabetes. AAT is an FDA-approved off-patent drug currently used to treat pulmonary emphysema among youngsters and adults with an AAT genetic deficiency.
"We designed the trial with the same dose of AAT that has been used safely and effectively for over 20 years," explains Dr. Lewis, who is the director of Israel's only Clinical Islet Laboratory and a senior lecturer in the Department of Clinical Biochemistry at BGU in Beer-Sheva, Israel.
Dr. Lewis received a generous five-year Young Scientist Career Development Award from the Juvenile Diabetes Research Foundation (JDRF). He has also received the prestigious Yigal Alon Scholarship, the Wolf Foundation Krill Award, a Marc Rich Foundation award and two Israel Science Foundation grants.
Dr. Lewis conducted and published research studies using animal models to demonstrate that AAT may be effective in reversing type 1 diabetes during his post-doctoral fellowship at the University of Colorado and later in his own lab at BGU. He determined that eliminating inflammation is the key to pancreatic islet beta cell survival and to restoring normal glucose levels.
This approach could potentially eliminate the need for daily insulin shots in recently diagnosed individuals, whose native circulating AAT molecules appear to be inactivated by high glucose. AAT is also potentially potent following pancreatic islet transplantation, sparing patients from intense immunosuppressive therapy. The procedure of islet transplantation is the only known approach today that affords continuous physiological glucos
|Contact: Andrew Lavin|
American Associates, Ben-Gurion University of the Negev