January 24, 2014

Little Orphan DiaVacs


orphanThe appeal of an orphan drug status makes investors drool. The enticing vixen is DiaVacs for the immune modifying treatment that won orphan status from the FDA.

For the sake of orphan diseases, big fishes like Pfizer, Amgen, and Gilead have no  interest in small fry diseases like T1D. However, when a company like DiaVacs steps onto the scene with a green light to Phase II trials, it grabs your attention.

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.

DV-0100 qualifies as a treatment for an orphan disease, Type 1 diabetes. Apparently because it’s the autoimmune type of diabetes, it is rare enough to win a status that only belongs to the minority. Fair enough. The shoe fits, and only 1 in 10 can wear it.

DiaVacs drug DV-0100 halts the autoimmune reaction against islet cells by modifying a patient’s own cells and injecting them back into the body.

Although this sounds a little unorthodox, there  were no safety issues in a phase I trial and some patients were able to produce insulin, so the drug has moved into phase II. Stay tuned for more exciting details in the T1D saga.

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