CytoAgents Announces FDA Acceptance of IND Application for CTO1681 to Treat Cytokine Release Syndrome in Oncology
CytoAgents, Inc., a clinical-stage biotechnology company developing a safe, effective treatment for Cytokine Release Syndrome (CRS), today announced that it has received a Study May Proceed letter from the U.S. Food and Drug Administration (FDA). This clearance enables the initiation of a U.S. Phase 1b/2a clinical trial under its Investigational New Drug (IND) application for the therapeutic, CTO1681, to treat CRS in lymphoma patients receiving CAR T-Cell Therapy. This is an area of great unmet medical need as the majority of patients undergoing CAR T treatment for their cancer experience CRS and associated neurotoxicity. “We are thrilled to advance CTO1681 into the clinic and excited about how our novel therapeutic will potentially prevent and/or treat CRS,” said Teresa Whalen, RPh, CEO of CytoAgents. Read more >>