Posted by Michael Wonder on 11 Jan 2017
ViraCyte granted U.S. FDA fast track designation for Viralym-C
10 January 2017 - ViraCyte today announced that the U.S. FDA has granted fast track designation for Viralym-C, ViraCyte’s T cell immunotherapy product designed to treat refractory cytomegalovirus infections in patients following a stem cell transplant.
In December, ViraCyte presented interim results of its Phase 1 Trial of Viralym-C at the American Society of Haematology Annual Meeting. In the 7 patients treated, all of whom failed conventional treatment, Viralym-C was well tolerated, safe, and achieved a positive clinical response in all 7 patients. In 6 of the 7 patients, the viral infection was completely eliminated. ViraCyte expects this Phase 1 study to conclude in early 2017, with advanced clinical trials to immediately follow. Dr. Ann Leen, Cofounder and Chief Scientific Officer stated, “These results, combined with results achieved in patients with other viral infections including BK virus and Adenovirus, attest to the game-changing, potentially life-saving nature of T cell therapy for otherwise untreatable diseases.”
