FDA Grants Orphan Drug Status to DiaVacs’s Type 1 Diabetes Reversal Drug

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DiaVacsThe FDA has granted orphan drug designation for the DiaVacs’s type 1 diabetes therapy, DV-0100. 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.

DiaVacs, Inc. is a clinical stage biotechnology company focused on the goal of curing autoimmune diseases. The proprietary technology utilized 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 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.

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 type 1 diabetes, 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 the 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.

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 type 1 diabetes and also qualifies the company for certain tax credits and waivers for prescription drug user fees.

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