Fast Track Designation for Refractory CMV After Transplant Treatment

The FDA has granted fast track designation to ViraCyte for Viralym-C, its T-cell immunotherapy product indicated to treat refractory cytomegalovirus after a patient has received a stem cell transplant.

Viralym-C is currently undergoing clinical trials with patients who have received a stem cell transplant. After a transplant, the body may be at risk of an infection due to a weakened immune system. Investigators are attempting to determine if they can use a type of white blood cell to treat infections that may occur in patients. The trial is expected to conclude by December 2017.

"Fast Track designation emphasizes the importance of new cell therapies, like Viralym-C, which hold unique promise in treating severe infections in patients with weakened immune systems such as adults and children following stem cell transplants," Brett Giroir, MD, President and CEO of ViraCyte, said in a press release. "ViraCyte looks forward to working with the FDA as we gather even more compelling data on the effectiveness and safety of our products."

In December, ViraCyte presented interim results from its phase 1 trial at the American Society of Hematology Annual Meeting. Seven patients who were treated with Viralym-C achieved a positive clinical response, and the drug was well tolerated, according to the release.