- First patient dosed in OXiGENE-sponsored expansion of investigator trial
- Phase 1b/2 dose-escalation study of OXi4503 as a single agent and in combination with cytarabine
SOUTH SAN FRANCISCO, Calif., Oct. 21, 2015 (GLOBE NEWSWIRE) -- OXiGENE, Inc. (Nasdaq:OXGN), a biopharmaceutical company developing vascular disrupting agents (VDAs) for the treatment of cancer, today announced that it has initiated a phase 1b/2 clinical trial (Study OX1222) of its investigational drug OXi4503 for treatment of acute myeloid leukemia (AML). 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.
"OXi4503 is a promising new investigational drug for patients with Myelodysplastic Syndromes and Acute Myeloid Leukemia," stated Christopher R. Cogle, M.D., Associate Professor of Medicine, University of Florida, and the principal investigator of the study. "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.
About OXiGENE
OXiGENE is a clinical-stage biopharmaceutical company developing vascular disrupting agents (VDAs) to treat cancer. VDAs selectively disrupt abnormal blood vessels that sustain tumors. The company's investigational drugs include CA4P (fosbretabulin), which is in development as a treatment for solid tumors, and OXi4503, which is in development for acute myeloid leukemia (AML). OXiGENE is dedicated to leveraging its intellectual property and therapeutic development expertise to bring life-extending and life-enhancing medicines to patients.
Safe Harbor Statement
This news release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Any or all of the forward-looking statements in this press release, which include the timing of advancement, outcomes, data and regulatory guidance relative to our clinical programs and achievement of our business and financing objectives may turn out to be wrong. Forward-looking statements can be affected by inaccurate assumptions OXiGENE might make or by known or unknown risks and uncertainties, including, but not limited to, the inherent risks of drug development, manufacturing and regulatory review, and the availability of additional financing to pursue and continue development of our programs. Additional information concerning factors that could cause actual results to materially differ from those in the forward-looking statements is contained in OXiGENE's reports to the Securities and Exchange Commission, including OXiGENE's reports on Form 10-K, 10-Q and 8-K. However, OXiGENE undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise. Please refer to our Annual Report on Form 10-K for the fiscal year ended December 31, 2014.