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Local Link to Diabetes Treatment Trials
For many individuals, a diagnosis of Type 1 diabetes means a life sentence of ongoing health issues and dependence on insulin injections. However, the outlook and fortunes for many of these patients may soon change, thanks to the efforts of Ben-Gurion University researcher and physician Dr. Eli Lewis.
After years of research, the innovative application established by Lewis — boosting the presence of illness-fighting alpha1-antitrypsin protein (or alpha1 for short) in diabetes patients — is proving a success in medical trials across the United States and in Israel.
The results of the first trial, funded by Colorado-based Omni Bio Pharmaceutical, Inc. (where Lewis is a member of the scientific board) — which included Philadelphia as a trial site — were published just a few months ago.
Lewis was in Philadelphia in April as a guest of the local branch of the American Associates, Ben Gurion University of the Negev. Among his topics of discussion was working with the physicians here on the project.
“We just formed a collaboration between the Philadelphia team and my team in Israel at BGU to see if our materials and theories could actually synergize,” he said.
“Both of our teams are working on molecules that the body produces naturally, so there is nothing synthetic or artificial. If the synergy between our teams work, then that’s a powerful combination.”
At one of the Ben-Gurion Association meetings scheduled while Lewis was here, Dana Heffernan-Green, a Texan whose son, Zach, was diagnosed with the disease, talked about her involvement in using the drug. She had heard about Lewis’ work and talked to her endocrinologist about her son taking the drug.
She did not participate in the trials but, instead, through the teamwork of Lewis and her own physician, got access to the drug, which she said led to remarkable results when her son took it under the guidance of the two doctors.
He is now insulin-free, she told the audience.
Lewis himself is heartened by the recent progress. “What we have been working on over the past several years is a prototype of a biologic drug form of alpha1 optimized for Type 1 diabetes, so that it can be more accessible, mass-produced, and not human-derived,” he explained of the drug now taken by infusion. But the hope, he said, is that rather than going through infusion — which can take an hour for the drug to be introduced totally into the body — there may be better options such as an injection, which might “make the intake of the material much easier for patients.”
As a result of this early success, more trials are being staged across the United States. Lewis is also in talks with Dr. Claresa Levetan, an endocrinologist with expertise spanning diverse areas of diabetes, about future collaborations.
Levetan is also the founder and chief scientific officer of Perle Bioscience, Inc., headquartered in South Carolina. She is noted for her recent discovery of BRAD, or Beta Regeneration Agents for Diabetes, four new gene peptides that bind directly to the pancreatic receptor in ductal tissue.
Currently, the natural anti-inflammatory alpha1 is FDA-approved for treatment in emphysema patients, a treatment available for the past 30 years or so. While approval for its use in treating diabetes is still anywhere from several months to years away, Lewis is excited about the findings on alpha1 successfully mitigating the effects of Type 1 diabetes.
“The bottom line is that we’re basically giving a naturally occurring healing molecule to somebody who has less of it, at a time that we choose, and for a duration that we choose. In many of these cases, the beta cells of the pancreas benefit greatly and recover,” said Lewis.
“Unlike many other proposed trials, alpha1 will offer families with diagnosed children an option for a treatment that is safe, and doesn’t present a dilemma between standard insulin injections and trying the treatment in the context of a trial.”