HOUSTON, Jan. 24, 2017 /PRNewswire/ -- ViraCyte, LLC, a clinical stage biopharmaceutical company developing immunotherapies for life threatening infections, announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug designation to Viralym-C, a ready to administer T cell immunotherapy product for the treatment of cytomegalovirus (CMV) in severely immunocompromised patients. On January 10, 2017, ViraCyte announced that Viralym-C also was granted FDA Fast Track Designation for the same indication.
For patients with weakened immune systems, CMV causes severe disease manifestations, including pneumonia, and can be fatal. "The FDA's decision to grant both Orphan Drug and Fast Track status for Viralym-C emphasizes the pressing, unmet medical needs of immunocompromised patients following stem cell transplantation," stated Dr. Sunitha Kakarla, Ph.D., Program Manager at ViraCyte. "In our Phase I clinical trial, all 8 patients who previously failed conventional therapy had positive clinical responses to Viralym-C, including 6 patients who were completely cleared of the virus."
The FDA Orphan Drug designation program provides incentives to sponsors who are developing therapies for rare diseases that affect fewer than 200,000 people in the United States. ViraCyte is now qualified to receive significant benefits throughout its orphan drug development program, including tax credits for clinical research costs, frequent FDA interactions, and protocol assistance. Also included is a waiver of Biologic Licensing Application (BLA) filing and user fees, and a seven-year term of market exclusivity upon FDA approval of the orphan drug.
"I am confident that ViraCyte will achieve additional important clinical and regulatory milestones in 2017, all of which enhance our ability to provide ViraCyte's unique T cell therapies to critically-ill patients," stated Dr. Brett Giroir, ViraCyte's Chief Executive Officer. "Our success continues to reflect our collaborative research and clinical relationships with many of the world's leading health care institutions in the Texas Medical Center."
About ViraCyte, LLC
ViraCyte's current products restore natural immunity against life threatening viruses in patients with severely weakened immune systems, such as adults and children who have recently undergone a hematopoietic stem cell transplant (HSCT). ViraCyte's lead T cell products are in Phase 1 and Phase 2 clinical trials, with effectiveness rates of greater than 90% in patients who have failed conventional therapy. More information can be found at www.viracyte.com
ViraCyte is a resident company at JLABS @ TMC, Houston, Texas.
SOURCE ViraCyte, LLC