Cantex Pharmaceuticals’ CX-01 receives FDA fast track designation in acute myeloid leukemia

Cantex Pharmaceuticals, a Florida-based biotechnology company, has achieved a significant milestone by securing Fast Track designation from the US Food and Drug Administration (FDA) for its innovative acute myeloid leukemia (AML) drug, CX-01. This designation is specifically for the treatment of patients over 60 years old undergoing induction therapy for newly diagnosed AML.

CX-01 is a novel polysaccharide drug designed to disrupt the chemokine activity that contributes to blood cancer resistance and delays bone marrow recovery post-chemotherapy. By targeting the adhesion of leukemia cells within the bone marrow, CX-01 aims to enhance the efficacy of leukemia treatments significantly. The drug is currently in clinical development not only for AML but also for refractory myelodysplastic syndrome.

The FDA’s Fast Track designation is an important step in expediting the development and review of drugs that address significant unmet medical needs. For CX-01, this designation highlights its potential to improve outcomes for older AML patients, who typically have lower response rates to initial therapy, higher relapse rates, and shorter overall survival.

Stephen Marcus, CEO of Cantex Pharmaceuticals, expressed the company’s commitment to addressing the challenges faced by older AML patients. “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 Marcus. He also noted that the Fast Track Designation underscores the recognition of CX-01’s potential to enhance front-line AML chemotherapy efficacy.

Derived from heparinoids, known for their anticoagulant properties, CX-01 also showcases biological and potential therapeutic benefits in treating blood cancers. The drug had previously received orphan drug designation in January 2018, further emphasizing its importance in the treatment landscape for AML.

The FDA’s recognition of CX-01 through the Fast Track designation reflects its potential to change the standard of care in AML treatment, especially for older patients. This development is a hopeful advancement for those affected by this challenging condition, potentially leading to more effective and faster treatment options.