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.