OXiGENE starts phase 1b/2 clinical trial of OXi4503 in acute myeloid leukemia

OXi4503, which has shown significant activity in preclinical studies of AML, is a novel VDA that is designed to reduce blood flow to tumors and to prevent cancer cells from replicating.

Study OX1222 is a continuation and expansion of a phase 1 single site clinical trial of OXi4503 conducted by the University of Florida (UF) with support from the Leukemia & Lymphoma Society.

OXiGENE is expanding upon the UF study to speed collection of additional safety and efficacy data and to obtain clinical data for OXi4503 in combination with cytarabine, which is an approved treatment for AML.

University of Florida associate professor of medicine and the principal investigator of the study Christopher Cogle said: "OXi4503 is a promising new investigational drug for patients with Myelodysplastic Syndromes and Acute Myeloid Leukemia.

"Blood vessels are hiding spots for these diseases. OXi4503 is a first-in-class drug that rouses sleeping leukemia cells from vascular beds and primes leukemia cells to cytarabine chemotherapy."

The American Cancer Society estimates that there are approximately 21,000 patients diagnosed with AML each year.

About Study OX1222

Study OX1222 is currently enrolling patients with relapsed or refractory AML or with Myelodysplastic Syndromes (MDS), and will study the safety and efficacy of OXi4503 administered weekly. The study is designed to enroll up to 27 patients in phase 1b and up to 78 patients in phase 2 stage.

The objectives of the study are to determine the maximum tolerated dose of OXi4503 both as a single agent and as part of combination therapy with intermediate-dose cytarabine chemotherapy, and to collect efficacy data as determined by the overall response rate. Data from both the open-label monotherapy and combination stages of the study are expected in 2016.