Cantex Pharmaceuticals, Inc. Announces FDA Orphan Drug Designation Has Been Granted to CX-01 for Treatment of Acute Myeloid Leukemia
WESTON, Fla., January 3, 2018 -- Cantex Pharmaceuticals, Inc., a clinical stage biopharmaceutical company developing proprietary pharmaceuticals that improve the treatment of cancers and other life-threatening disorders, today announced that the U.S. Food and Drug Administration (“FDA”) has granted Orphan Drug Designation to CX-01 for the treatment of acute myeloid leukemia (“AML”). 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. This 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.
Stephen Marcus, M.D., Chief Executive Officer of Cantex Pharmaceuticals, Inc., stated, “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. 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.”
About Orphan Drug Designation
The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. Orphan Drug Designation provides important incentives, including seven-year marketing exclusivity upon FDA approval, tax credits for qualified clinical testing, and prescription drug user fee exemption.
About Cantex Pharmaceuticals, Inc.
Cantex is a clinical stage biopharmaceutical company focused on developing and commercializing proprietary compounds that enhance the efficacy and safety of the treatment of cancer and other life-threatening disorders. Cantex’s product candidate, CX-01, is a multi-targeted new chemical entity in development for the treatment of acute myeloid leukemia and myelodysplastic syndrome. Cantex's other clinical stage product, Dicopp™, a proprietary combination of disulfiram + copper, is currently in clinical trials for recurrent glioblastoma and metastatic castration-resistant prostate cancer. For more information, please visit www.cantex.com.
Source: Cantex Pharmaceuticals, Inc.
Posted: January 2018
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