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

EDGEWATER, N.J. and SAN DIEGO, Feb. 12, 2014 /PRNewswire/ -- 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.

About DiaVacs, Inc.
DiaVacs, Inc. is a clinical stage biotechnology company focused on the audacious goal of curing auto-immune diseases. The proprietary technology we utilize is designed to re-induce tolerance into the patient's immune system so that the vicious cycle of auto-immunity is halted. Our goal is to demonstrate that once the autoimmune reaction is halted, early in the disease course, the remaining cells either regenerate or have enough cell mass and functionality remaining so that the disease progress is halted or cured.

Our first indication is type 1 diabetes mellitus (T1DM). T1DM, formerly known as juvenile onset diabetes, is a condition that can occur at any age but predominantly affects children and adolescents, requires lifelong insulin injections and regular glucose monitoring.  Precise insulin regulation and normalized glucose control remain elusive goals, and as a result, affected persons remain at risk for diabetes-related complications, including visual impairment, kidney disease, amputations, cardiovascular disease events and premature mortality. Historically, there are excess health care costs associated with this disease over the lifetime of affected persons, primarily due to management of late stage complications. T1DM disease is caused by the triggering of an autoimmune response against the beta cells of the pancreatic islets, which are destroyed over the course of several months, resulting in insulin dependency. For more information, visit the company's website at www.diavacs.com.

About Profil® Institute for Clinical Research, Inc.
Profil Institute for Clinical Research, Inc. is an early phase clinical research organization focused on diabetes and obesity.  The company is renowned as a center of excellence for metabolic clinical research and development based on its scientific expertise, end-to-end early phase services, and research methodologies.  Profil Institute has completed more than 200 phase I-IIa diabetes and obesity clinical programs involving every clinically relevant diabetes drug class and medical device in the last decade.  For more information about Profil Institute for Clinical Research, please visit www.profilinstitute.com.

SOURCE Profil Institute for Clinical Research, Inc.