On June 7, 2017 Mateon Therapeutics, Inc. (OTCQX:MATN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of orphan oncology indications, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the company’s product candidate OXi4503 for the treatment of acute myeloid leukemia (AML) (Press release, Mateon Therapeutics, JUN 7, 2017, View Source [SID1234519457]). Schedule your 30 min Free 1stOncology Demo! Fast Track designation is a process designed to facilitate the development and expedite the review of drugs to treat serious or life-threatening conditions and address unmet medical need. Once an investigational agent receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication allows potential issues to be resolved quickly and as they arise, often leading to earlier drug approval and access by patients.
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"The receipt of Fast Track designation from the FDA represents an important milestone for our OXi4503 program and follows promising results, including three complete remissions, from the initial cohorts of our on-going OX1222 study in patients with relapsed/refractory AML," said William D. Schwieterman, M.D., President and Chief Executive Officer of Mateon. "This latest development provides further momentum for this groundbreaking study, and occurs in advance of the completion of the fifth patient cohort in OX1222 – which we expect by the end of this year."
About Acute Myeloid Leukemia
A devastating form of cancer of the blood and bone marrow, AML is the most common type of acute leukemia in adults and accounts for the greatest number of leukemia deaths in the United States. There is no standard regimen of care for patients who relapse following front-line treatment or have refractory disease. According to the NIH’s National Cancer Institute Surveillance, Epidemiology and End Results (SEER) program, there are an estimated 21,380 new cases and 10,590 deaths expected in 2017 in the United States. AML arises from a clonal hematopoietic stem cell and is characterized by accumulation of malignant myeloblasts in the bone marrow and resulting in ineffective hematopoiesis. AML often responds initially to front-line treatment of conventional cytotoxic chemotherapy, but it often relapses and long-term disease-free survival is low, posing a significant challenge to treat relapsed and/or refractory disease.
About OXi4503
OXi4503 (combretastatin A1-diphosphate or CA1P) is a dual-mechanism vascular disrupting agent. In preclinical and clinical studies, it has been observed to compromise the tumor vasculature, resulting in extensive tumor cell death and necrosis while also possibly affecting the cell shape and attachment of hematopoietic stem cells. OXi4503 is being evaluated for relapsed/refractory AML and myelodysplastic syndrome (MDS) in combination with cytarabine in OX1222, a phase 1b/2 study. In addition to Fast Track status, OXi4503 has been granted orphan drug designation for the treatment of AML in both the United States and Europe.