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 P : 201 855 9792 F : 201 254 8095 W : www.DiaVacs.com DiaVacs’s Immunotherapy Product for Treatment
of Type 1 Diabetes Receives Orphan Drug Status
Designation from the FDA
Edgewater, NJ, January 6, 2014 - 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. DV0100 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.
About DiaVacs
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 reinduce tolerance into the patient's immune system so that the vicious cycle of autoimmunity is halted. The company’s goal is to demonstrate that once the autoimmune
401 Tower Drive, Edgewater, NJ 07020 P : 201 855 9792 F : 201 254 8095 W : www.DiaVacs.com 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.
Contact: Haro Hartounian, Ph.D.: 201 855 9792
401 Tower Drive, Edgewater, NJ 07020