Cantex Pharmaceuticals, a Florida-based biotech company, has secured the fast track designation for its acute myeloid leukemia drug CX-01 from the US Food and Drug Administration (FDA).
The FDA fast track designation for CX-01 is for the treatment of patients, aged over 60, who are being subjected to induction therapy for newly diagnosed acute myeloid leukemia.
CX-01 is a polysaccharide that has been designed to inhibit the activity of chemokines that make blood cancers resistant to treatment apart from causing delay of bone marrow recovery after chemotherapy.
The acute myeloid leukemia drug is believed to have the potential to improve the effectiveness of leukemia treatments by destroying the adhesion of leukemia cells in the protective bone marrow environment.
According to Cantex Pharmaceuticals, CX-01 is derived from heparinoids, which are considered to have biologic and potential therapeutic properties separate from their popular use as anticoagulants.
Currently, CX-01 is in clinical development for newly diagnosed acute myeloid leukemia and also refractory myelodysplastic syndrome.
Stephen Marcus – CEO of Cantex Pharmaceuticals, commenting on the FDA fast track designation of its acute myeloid leukemia drug CX-01, said: “Over age 60, the response to initial ‘induction’ therapy is lower, the risk of relapse is higher, and the overall survival is generally shorter, creating a significant unmet medical need for improvement in the effectiveness of this induction therapy.”
“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 front-line AML chemotherapy.
Prior to its fast track designation, Cantex Pharmaceuticals’ acute myeloid leukemia drug CX-01 was granted orphan drug designation in January 2018 from the FDA for the same condition.
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