Type 1 Drug Wins Orphan Status

| Jan 16, 2014

DV-100, a drug designed to halt the body's autoimmune attack on pancreatic beta cells that leads to type 1 disease, has won orphan drug status from the U.S. Food and Drug Administration.

Designation as an orphan drug gives DV-100's manufacturer, New Jersey-based biotechnology company DiaVacs, Inc., seven years of exclusive marketing rights in the United States once DV-100 receives final FDA approval.

Currently, the drug has just entered Phase 2 trials on human test subjects.

The drug is based on using modified version of a type 1 patient's dendritic cells* as a vaccine. The cells are injected under the skin, absorbed into the body, and then circulated to the pancreatic lymph nodes where they combat the body's mistaken autoimmune attack on that organ's insulin-producing beta cells.

DiaVacs reports that in the Phase 1 human trial, beta cell protection afforded by DV-100 in some cases allowed type 1 patients to begin producing their own insulin as long as 10 years after their diagnosis.

*Dendritic cells are key immune system cells that produce the body's initial response to outside agents--antigens--by "presenting" them to the body's infection-fighting T cells in forms that they will recognize as they protect the body. By modifying T cells' mistaken aggressive response to the body's own benign pancreatic beta cells, DV-100 protects the cells from further attack.

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Categories: Dendritic Cells, DiaVacs, DV-100, FDA, Orphan Drug, Type 1


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