2015 European Trial Set with Goal of Insulin Independence
Rome, Italy (December 18, 2014) – Perle Bioscience, Inc. announces the Insulin Independence Trial (IIT). The trial has a primary endpoint of insulin independence among recent onset type 1 diabetes patients.
The Perle Bioscience Team and trial’s lead investigator, Dr. Paolo Pozzilli, met with investigators from 10 potential trial sites across Europe to initiate the study in Rome, Italy on December 13th-14th 2014. Rome is the first European location to be announced to conduct the IIT. The multi-location trial is slated to begin patient enrollment in the early spring of 2015.
According to Dr. Claresa Levetan, Founder and Chief Medical Officer of Perle Bioscience, “This is Perle Bioscience’s first study utilizing a novel platform of combining a beta regeneration therapy with an immune therapy with the endpoint of insulin independence among patients with new onset type 1 diabetes who have remaining beta cells.”
The Insulin Independence Trial will also be the first of its kind to combine the usage of an immune tolerance agent and a therapy for beta cell regeneration, each of which are FDA (Federal Drug Administration) and EMA (European Medical Agency) approved. The trial uses a low dose of the immunosuppressant cyclosporine, which has the highest rates of insulin independence among more than 500 patients with new onset type 1 diabetes (Ref: Levetan et al. 2013). Cyclosporine will be used in combination with a proton pump inhibitor that increases gastrin. In separate clinical studies, gastrin has been shown to transform one’s own pancreatic ducts to new insulin-producing islets (Ref: Wang et al. 1993).
The kickoff meeting in Rome, led by Dr. Pozzilli, finalized the parameters for the study, as well as confirmed the initial trial locations. Six to eight locations will be at hospitals around Italy, the first to be in Rome, and two additional locations are scheduled outside of Italy.
“We are thrilled to have Dr. Pozzilli as the lead investigator in Europe,” says Dr. Ryan Fiorini, President & CEO of Perle Bioscience. “Dr. Pozzilli is considered a leading type 1 diabetes specialist in Europe, who has been a recipient of numerous diabetes research awards and been an investigator on almost every immune therapy trial among patients with type 1 diabetes.” Dr. Pozzilli is a Professor of Endocrinology & Metabolic Diseases and Head of the Department at Campus Bio-Medico University of Rome. He is also a Professor of Diabetes and Clinical Research at the Centre for Diabetes at Barts and The London School of Medicine & Dentistry.
The Insulin Independence Trial will launch in Europe, with the goal of U.S. patient enrollment in similar U.S. based trials upon future FDA approval. For more information on Perle Bioscience, please visit: http://www.PerleBioscience.com.
About Perle Bioscience:
Founded in 2013 by Dr. Claresa Levetan, Perle Bioscience is dedicated to finding original treatments for type 1 diabetes with the ultimate goal of eliminating the disease all together. Perle has discovered novel human beta regeneration peptides for which has been issued “composition of matter” patents. Perle’s total IP portfolio comprises 12 issued and pending patents all in the diabetes space. Perle’s intellectual property is established around the In Vivo use of proton pump inhibitors combined with immune tolerance agents, with the ultimate goal of eliminating any injections for the patients. To learn more, please visit us at www.PerleBioscience.com.
Dr. Ryan Fiorini
CEO & President
Perle Bioscience, Inc.