This article is more than 5 years old. Information may no longer be current.
FDA grants fast track designation to CX-01 for acute myeloid leukemia
Click Here to Manage Email Alerts
The FDA granted CX-01 fast track designation for the treatment of adults aged older than 60 years with newly diagnosed acute myeloid leukemia, according to the agent’s manufacturer.
CX-01 (Cantex) is designed to block the activity of chemokines, such as CXCR4, CXCL12 and platelet factor 4, which promote resistance to treatment among blood cancers and delay bone marrow recovery after chemotherapy.
“We believe that the award of fast track designation represents recognition of CX-01’s potential to address a significant unmet need in the treatment of AML by enhancing the efficacy of frontline AML chemotherapy,” Stephen Marcus, MD, CEO of Cantex Pharmaceuticals, said in a company-issued press release. “We will work closely with major cancer treatment centers and with the FDA with the goal of bringing CX-01 to patients as quickly as possible."
The FDA also granted CX-01 orphan drug designation.
The agent is in clinical development for AML and refractory myelodysplastic syndrome.