The Food and Drug Administration (FDA) has granted Fast Track designation to CX-01 (Cantex Pharmaceuticals), a treatment in development for patients over 60 years who are newly diagnosed with acute myeloid leukemia (AML). 

According to the Company, CX-01 is a polysaccharide that neutralizes the activity of proteins that play a role in the adhesion of leukemia stem cells to the protective bone marrow environment, and neutralizes the activity of platelet factor 4, a cytokine which suppresses and delays platelet recovery after chemotherapy. 

“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,” said Stephen Marcus, MD, CEO of Cantex Pharmaceuticals. 

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CX-01 was granted Orphan Drug designation for AML earlier this year; the treatment is also being evaluated in patients with myelodysplastic syndrome. 

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