On August 27, 2018 Cantex Pharmaceuticals, Inc., a clinical stage biopharmaceutical company developing proprietary pharmaceuticals for the treatment of cancer, reported that the U.S. Food and Drug Administration ("FDA") has granted Fast Track Designation for Cantex’s lead product candidate, CX-01, for the treatment of patients over age 60 receiving induction therapy for newly diagnosed acute myeloid leukemia ("AML") (Press release, Cantex, AUG 27, 2018, View Source [SID1234529084]). Earlier this year, the FDA had also granted Orphan Drug Designation to CX-01 for the treatment of AML.
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Fast Track Designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. A drug development program with Fast Track Designation is afforded greater access to FDA for the purpose of expediting the drug’s development, review and potential approval.
CX-01 is currently in clinical development for newly diagnosed AML, and refractory myelodysplastic syndrome ("MDS"). CX-01 is designed to block the activity of chemokines that support the resistance of blood cancers to treatment and that contribute to the delay of bone marrow recovery after chemotherapy. Among these chemokines are CXCR4 and CXCL12, which are critical to the attachment of blood cancer cells to the protective bone marrow environment, and platelet factor 4, which slows bone marrow recovery after chemotherapy.
Stephen Marcus, M.D., Chief Executive Officer of Cantex Pharmaceuticals, Inc., commented, "Acute myeloid leukemia (AML) is the most common form of acute leukemia in adults, with approximately 19,500 new cases, more than 60% of which are in people over age 60, estimated in the United States for 2018. 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." Dr. Marcus added, "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. We will work closely with major cancer treatment centers and with the FDA with the goal of bringing CX-01 to patients as quickly as possible."
About Fast Track Designation
Fast Track Designation is intended to facilitate development and expedite review of drugs to treat serious and life-threatening conditions. A drug that qualifies for Fast Track Designation must demonstrate the potential to treat a serious condition for which there is an unmet medical need for improved treatment.
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.