DiaVacs's Immunotherapy Product for Treatment of Type 1 Diabetes Receives Orphan Drug Status Designation from the FDA
06 Jan, 2014, 06:00 ET
EDGEWATER, N.J., Jan. 6, 2014 /PRNewswire/ -- DiaVacs, Inc. announced today that the Office of Orphan Products Development of the Food and Drug Administration (FDA) has granted orphan drug designation for the company's type 1 diabetes mellitus (T1DM) therapy. DV-0100 is proprietary, novel and safe. The therapy halt's the body's autoimmune reaction against the pancreatic islet cells which are responsible for producing insulin, thus allowing them to produce insulin normally and reversing the trajectory of the disease. Orphan designation qualifies DV-0100 for seven years of marketing exclusivity in the U.S. if the company is the first to obtain marketing approval for this product in T1DM and also qualifies the company for certain tax credits and waivers for prescription drug user fees.
"The granting of this orphan drug designation represents a key milestone for the company," commented Dr. Haro Hartounian, CEO of DiaVacs. "We are excited by the promise that DV-0100 showed in our Phase 1 clinical trial and look forward to assessing its therapeutic potential in the ongoing Phase 2 clinical trial for this indication."
The proprietary DiaVacs technology is derived from a deep understanding of the human immune system. The company has perfected the immunology and technology to take a patient's own dendritic cells (DC) from their blood, modify the cells through the use of small interfering oligonucleotides, and vaccinate the patient by injection of these modified cells under the skin with a small needle. The cells are absorbed, trafficked to the pancreatic lymph nodes, and thereby induce tolerance. This therapy has been shown to be safe and effective in animal models of T1DM, and evidenced no safety signals in human Phase 1 trials in patients with established type 1 diabetes for five years or longer. In some patients in our Phase 1 human trial, production of endogenous insulin was measured, even after 10 years of disease. The FDA has approved, and the company has initiated, a Phase 2 human trial.
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. The company's 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
SOURCE DiaVacs, Inc.
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