DiaVacs Announces a Strategic Collaboration with Profil Institute to Conduct Phase IB/IIA Randomized Clinical Trial of New Cell-Based Therapy for Type 1 Diabetes

Published on: February 12, 2014

Company News Release

Clinical program focused on reversing type 1 diabetes symptoms in patients diagnosed within six months of trial initiation

DiaVacs, Inc., a clinical stage biotechnology company focused on developing cell-based therapy for treatment of type 1 diabetes, and Profil® Institute for Clinical Research, Inc., an early phase clinical research organization focused on diabetes and obesity, announced today a strategic collaboration to conduct DiaVacs' phase Ib/IIa clinical trial. This clinical trial will study the safety and preliminary efficacy of DiaVacs' novel dendritic cell therapy for treatment of type 1 diabetes in patients who are newly diagnosed.

DiaVacs' proprietary technology is based on dendritic cell therapy. DiaVacs has perfected the immunology and technology to take a patient's own dendritic cells from their blood, modify them through the use of small interfering oligonucleotides, and then vaccinate the patient by simple injection of these modified cells under the skin using a small needle. The cells are taken up and trafficked to the pancreatic lymph nodes where they take up residence and induce tolerance. This cell-based therapy has been shown to be safe in phase I human trials and effective at halting disease progression in preclinical models of disease.

The double-blind, placebo-controlled study will begin by first enrolling 10 subjects who are at least 18 years of age with newly diagnosed type 1 diabetes (< 6 months from diagnosis). A fifteen month commitment will be required of all study participants, including multiple visits to Profil Institute's San Diego clinical facility. Thereafter, the study will expand the inclusion criteria to include younger participants who are newly diagnosed. The primary efficacy endpoint of the study is evidence of the return of insulin secretion by the pancreas. Additionally, various immune markers will be assessed for evidence that the autoimmune process responsible for type 1 diabetes has been altered.