Navigation Links
FDA approves trial for type 1 diabetes treatment by Ben-Gurion U. and U. Colorado

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 glucose levels to patients with diabetes.

According to Dr. Lewis, "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 literally modify the immune response, which facilitates transplant acceptance to treat diabetes."

The study protocol provides for AAT administration during an eight-week treatment period in an initial group of 15 individuals with recently diagnosed diabetes, potentially expanding to up to 50 patients. As in most other diabetes trials, enrolled patients will be monitored for two years.

"Dr. Lewis is at the forefront of research in his field to find a treatment for type 1 diabetes and we're very excited that BGU is exporting its pioneering research once again to the U.S.," says Doron Krakow, executive vice president of American Associates, Ben-Gurion University of the Negev. "We wish Eli success with the trials and hope that his findings lead to a cure for a disease that affects millions of people around the world."


Contact: Andrew Lavin
American Associates, Ben-Gurion University of the Negev

Related biology news :

1. Court Approves Scheme of Arrangement
2. Digimarc Board Approves $310 Million All-Cash Offer from L-1 Identity Solutions for Digimarcs ID Systems Business
3. FDA approves Vidaza label expansion
4. NSF approves $1.3M for OSU and OU microbes hunt
5. DFG approves funding for 17 new collaborative research centers
6. DFG approves 12 new collaborative research centers
7. U of M begins nations first clinical trial using T-reg cells from cord blood in leukemia treatment
8. Vitamin E trials fatally flawed
9. Research team says extraterrestrial impact to blame for Ice Age extinctions
10. Trial seeks genetic fingerprint for predicting drug effectiveness
11. The industrial space age
Post Your Comments:
(Date:6/22/2016)... ANGELES , June 22, 2016 /PRNewswire/ ... identity management and verification solutions, has partnered ... edge software solutions for Visitor Management, Self-Service ... provides products that add functional enhancements ... partnership provides corporations and venues with an ...
(Date:6/20/2016)... 20, 2016 Securus Technologies, a leading ... for public safety, investigation, corrections and monitoring announced ... it has secured the final acceptance by all ... Managed Access Systems (MAS) installed. Furthermore, Securus will ... be installed by October, 2016. MAS distinguishes between ...
(Date:6/9/2016)... , June 9, 2016  Perkotek an innovation leader in attendance control systems is ... log work hours, for employers to make sure the right employees are actually signing ... ... ... ...
Breaking Biology News(10 mins):
(Date:6/27/2016)... ... June 27, 2016 , ... Newly created 4Sight Medical ... to the healthcare market. The company's primary focus is on new product introductions, ... strategies that are necessary to help companies efficiently bring their products to market. ...
(Date:6/27/2016)...  Liquid Biotech USA , ... Sponsored Research Agreement with The University of Pennsylvania ... cancer patients.  The funding will be used to ... clinical outcomes in cancer patients undergoing a variety ... employed to support the design of a therapeutic, ...
(Date:6/24/2016)... 2016  Regular discussions on a range of subjects including ... two entities said Poloz. Speaking at a lecture ... , he pointed to the country,s inflation target, which is ... "In certain areas there ... common economic goals, why not sit down and address strategy ...
(Date:6/24/2016)... ... 24, 2016 , ... While the majority of commercial spectrophotometers and fluorometers use ... 6000i models are higher end machines that use the more unconventional z-dimension of 20mm. ... from the bottom of the cuvette holder. , FireflySci has developed several Agilent ...
Breaking Biology Technology: