Cantex Pharmaceuticals, Inc. announces FDA orphan drug designation has been granted to CX-01 for treatment of acute myeloid leukemia.
Cantex Pharmaceuticals, Inc., a clinical stage biopharmaceutical company developing proprietary pharmaceuticals for the treatment of cancers and other life-threatening disorders, announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation to CX-01 for the treatment of acute myeloid leukemia.
CX-01 is an investigational agent that has the potential to enhance the effectiveness of leukemia treatments by disrupting the adhesion of leukemia cells in the protective bone marrow environment.
Cantex is currently conducting a 75-patient randomized phase IIb study in more than 20 U.S. medical centers to determine whether CX-01 can improve the efficacy of front-line chemotherapy of acute myeloid leukemia.
The study builds upon a previously completed open-label, non-randomized phase IIa clinical trial in AML where CX-01 was administered in combination with induction chemotherapy to 11 patients with newly diagnosed primary AML. Results from the phase IIa study indicated that all 11 patients achieved a complete remission following a single cycle of chemotherapy treatment.
“We are pleased to have been granted FDA Orphan Drug Designation for CX-01 in AML, which follows the receipt of FDA Orphan Drug Designation for our second product candidate, Dicopp (previously known as CX-02), for glioblastoma,” Stephen Marcus, M.D., chief executive officer of Cantex Pharmaceuticals, Inc., said. “In addition to our randomized study of CX-01 in front-line treatment of acute myeloid leukemia, we are also supporting an investigator-initiated study of CX-01 in refractory myelodysplastic syndrome and refractory acute myeloid leukemia”.
(Source: Cantex Pharmaceuticals, Inc.)
Filed Under: Drug Discovery