Dr. Eli Lewis Secures Approval to Start Human Clinical Trial of AAT
Just a few days ago, the FDA gave it's clearance for phase I/II human clinical trials evaluating Apha-1 Antitrypsin, also known as AAT in type 1 diabetics, based on the research of Dr. Eli Lewis and his team at Ben-Gurion University of the Negev.
In April, Dr. Lewis shared his research and how it could be used for both type 1 and type 2. Many people left comments on this post, and Dr. Lewis has continued to post updates to his blog on the FDA process, and I was delighted to see the good news! Please be assured that you may leave Dr. Lewis comments here as well regarding your questions, and we will be sure to ask for updates as the trial moves into action.
To recap, AAT is a drug that has been in the marketplace for over 20 years, primarily used to treat emphysema and for people who had a genetic deficiency of AAT. What Dr. Lewis' team found was that they could reverse the inflammatory response, which allows the islet beta cells, or insulin producing cells, to survive and restore normal glucose levels!
Dr. Lewis' studies theorize that when high levels of glucose are circulating in the blood, the AAT molecules are inactivated. By bringing the AAT levels back up to normal levels, the body could, in theory, protect the insulin producing beta cells and shots would be unnecessary (wow!), I say "in theory" because the protocol has only worked in mice thus far. Now comes the real test - the human body!
The other application of AAT is for transplants. Dr. Lewis said, "We found that targeting multiple inflammatory molecules by using a safe, non-toxic and non-steroidal drug, we can block inflammation so effectively that we can literally modify the immune response, which facilitates transplant acceptance to treat diabetes."
The study protocol provides AAT administration during an eight-week treatment period for an initial group of 15 individuals that have been recently diagnosed diabetes, potentially expanding to 50 patients. After acceptance into the trial, the eight-week protocol patients will be monitored for two years. Trials are set to begin soon.
The phase I/II clinical trial is being sponsored by Omni Biopharma at the Barbara Davis Center for Childhood Diabetes as well as other units at Anschutz Medical Campus of the University of Colorado in Denver.
In all the years I've lived with diabetes, I feel like we are getting to the point where we will knock this disease down, not with a silver bullet, but with baby steps. The easiest step is to start with newly diagnosed patients; I have tremendous hope for the newly diagnosed to live a life with diabetes without suffering. With many trials for newly diagnosed in phase I/II/III, something is bound to change type 1 diabetes' role in today's world.