FDA Approves Trial for Diabetes Drug

As reported in Israel 21C: The US Food & Drug Administration (FDA) has granted Investigational New Drug 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 (BGU) of the Negev.

Recipient of a number of grants and awards, Lewis is at the forefront of research in his field to find a treatment for type 1 diabetes.

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.

Lewis conducted and published research studies using animal models to demonstrate that AAT may be effective in reversing type 1diabetes 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 treatment approach, developed by researchers from BGU and the University of Colorado, 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.

It can block inflammation so effectively that the immune response is modified, facilitating transplant acceptance to treat diabetes.

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