(By Balaseshan) OXiGENE Inc. (NASDAQ: OXGN) said its product candidate OXi4503 has received orphan designation from the U.S. Food and Drug Administration to treat acute myelogenous leukemia (AML).
OXi4503 is a novel, second-generation anticancer agent that combines vascular disrupting activity with direct cytotoxicity. A Phase 1 study of OXi4503 for the treatment of patients with AML or myelodysplastic syndrome (MDS) is currently under way, with support from The Leukemia & Lymphoma Society's Therapy Acceleration Program.
"We believe that orphan designation in the US may increase the attractiveness of OXi4503 as a partnering asset, and we plan to seek orphan designation in the European Union as well. We look forward to having initial results from the ongoing Phase 1 trial in AML before the end of 2012," said Peter Langecker, chief executive of OXiGENE.
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Orphan drug designation qualifies a company for several benefits, including the potential for market exclusivity, development grants, and for certain tax credits.
OXi4503 (combretastatin A1 diphosphate /CA1P) is a dual-mechanism vascular disrupting agent that is being developed in clinical trials for the treatment of leukemias and solid tumors. Like its structural analog, ZYBRESTAT (fosbretabulin/CA4P), OXi4503 has been observed to block and destroy tumor vasculature, resulting in extensive tumor cell death and necrosis.
In addition, preclinical data indicate that OXi4503 is metabolized by oxidative enzymes (e.g., tyrosinase and peroxidases), which are elevated in many solid tumors and tumor white blood cell infiltrates, to an orthoquinone chemical species that has direct cytotoxic effects on tumor cells.
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Preclinical studies have shown that OXi4503 has single-agent activity against a range of xenograft tumor models, and synergistic or additive effects when incorporated in various combination regimens with chemotherapy, molecularly-targeted therapies (including tumor-angiogenesis inhibitors), and radiation therapy.
OXGN is trading up 8.05 percent at $0.411 on Wednesday. The stock has been trading between $0.31 and $1.37 for the past 52 weeks.