Promising Clinical Trial of Type 1 Diabetes Treatment
Promising Clinical Trial of Type 1 Diabetes Treatment
February 20, 2014
Medical Research, Press Releases
DENVER, Colorado, February 20, 2014 – A clinical study on a promising treatment for Type 1 diabetes developed by a Ben-Gurion University of the Negev (BGU) researcher in collaboration with the University of Colorado Health Science Center had an “exceptional outcome” after an eight week treatment of Alpha1-Antitrypsin (AAT).
According to the study published in the Journal of Clinical Endocrinology and Metabolism, the goal was to evaluate safety and effect of a novel therapy using the anti-inflammatory serum protein Alpha1-Antitrypsin (AAT) in Type 1 diabetes patients in the first of three published Phase 1 open trials.
“Following treatment of eight to 12 weeks with AAT, in several patients, it allowed proper glucose levels to be controlled without the need for any insulin injections for more than two years,” said Dr. Lewis, who is director of the BGU Clinical Islet Laboratory and a lecturer in clinical biochemistry, pharmacology and immunology for the faculty of Health Sciences at BGU.
In addition, diabetes patients, even youngsters and adolescents, showed no adverse affects and a remarkable safety profile.”
“This is an excellent beginning in our mission to determine the exciting possibilities of a safe therapy for autoimmune diabetes,” Dr. Lewis explains.
“We believe we will see similar results in a number of U.S. patients who recently received this treatment outside the trials within several months of diagnosis and are still completely insulin free.”
The researchers are now recruiting for three more extension trials. However, it will still be a minimum of two years for AAT to receive FDA approval as an on-label treatment for Type 1 diabetes.
The treatment course was comprised of a weekly infusion-drip of AAT, then a yearlong follow-up with 12 patients.
“Patient compliance was maximal, an impressive achievement when one considers several ongoing trials in Type 1 Diabetes that offer poorly tolerated approaches,” Dr. Lewis explains.
The Study was funded by Omni Bio Pharmaceutical Inc. Dr. Dinarello has received research support from National Institutes of Health, grant AI 15614.
ABOUT AMERICANS FOR BEN-GURION UNIVERSITY
By supporting a world-class academic institution that not only nurtures the Negev, but also shares its expertise locally and globally, Americans for Ben-Gurion University engages a community of Americans who are committed to improving the world. David Ben-Gurion envisioned that Israel’s future would be forged in the Negev. The cutting-edge research carried out at Ben-Gurion University drives that vision by sustaining a desert Silicon Valley, with the “Stanford of the Negev” at its center. The Americans for Ben-Gurion University movement supports a 21st century unifying vision for Israel by rallying around BGU’s remarkable work and role as an apolitical beacon of light in the Negev desert.
About Ben-Gurion University of the Negev
Ben-Gurion University of the Negev embraces the endless potential we have as individuals and as a commonality to adapt and to thrive in changing environments. Inspired by our location in the desert, we aim to discover, to create, and to develop solutions to dynamic challenges, to pose questions that have yet to be asked, and to push beyond the boundaries of the commonly accepted and possible.
We are proud to be a central force for inclusion, diversity and innovation in Israel, and we strive to extend the Negev’s potential and our entrepreneurial spirit throughout the world. For example, the multi-disciplinary School for Sustainability and Climate Change at BGU leverages over 50 years of expertise on living and thriving in the desert into scalable solutions for people everywhere.
BGU at a glance:
20,000 students | 800 senior faculty | 3 campuses | 6 faculties: humanities & social sciences, health sciences, engineering sciences, natural sciences, business & management, and desert research.
For all press inquiries, please contact:
James Fattal, J Cubed Communications
516.289.1496
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