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The U.S. Food and Drug Administration has granted fast track designation to Burlington biotech startup AlloCure Inc. for AC607, its potential treatment of acute kidney injury (AKI).
The treatment, AC607, is a bone marrow-derived mesenchymal stem cell treatment from adult stem cell donors that is meant as an alternative to dialysis. It is designed to stimulate organ repair, and it does so, AlloCure said in a news release, without needing to meet blood or tissue typing requirements.
The FDA fast track designation is intended to speed development and review of drug and treatment candidates for serious or life-threatening conditions currently without treatment.
AlloCure is planning to launch a Phase 2 clinical trial of AC607 in the first half of 2012.
Founded in 2008 as NephroGen, privately held AlloCure raised a $14.5 million Series A funding round from SV Lide Sciences and Novo A/S in 2008. The company has another location in Salt Lake City, Utah.
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