Mateon Therapeutics Receives FDA Fast Track Designation

Mateon Therapeutics, Inc. recently announced that the US FDA has granted Fast Track designation to the company’s product candidate OXi4503 for the treatment of acute myeloid leukemia (AML).

“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, MD, 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.”

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 US. 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 US. 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.

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 US and Europe.

Mateon Therapeutics, Inc. is a biopharmaceutical company seeking to realize the full potential of vascular targeted therapy (VTT) in oncology. VTT includes vascular disrupting agents (VDAs) such as the investigational drugs that Mateon is developing, and anti-angiogenic agents (AAs), a number of which are FDA-approved and widely used in cancer treatment. These two approaches have distinct yet complementary mechanisms of action. At Mateon, we believe that we can significantly improve cancer therapy by employing these two complementary approaches simultaneously. When utilized this way, VDAs obstruct existing blood vessels in the tumor leading to significant central tumor cell death while AAs prevent the formation of new tumor blood vessels. Mateon is committed to leveraging our intellectual property and the product development expertise of our highly skilled management team to enable VTT to realize its true potential and to bring much-needed new therapies to cancer patients worldwide. For more information, visit www.mateon.com.