ViraCyte, LLC announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Viralym-C, ViraCyte's T cell immunotherapy product designed to treat refractory cytomegalovirus (CMV) infections in patients following a stem cell transplant.
Fast Track designation is designed to expedite the development and review of new therapies to treat serious conditions for which patients have a significant unmet medical need. Advantages of Fast Track designation include more frequent interactions with the FDA during all aspects of development of the therapy, and eligibility for priority review and accelerated approval. "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," said Brett Giroir, M.D, President and CEO of ViraCyte. "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 of its Phase 1 Trial of Viralym-C at the American Society of Hematology 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."