WALTHAM, Mass., April 6, 2009 (GLOBE NEWSWIRE) -- OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, announced that the company has initiated a Phase 1b/2a study of its dual-mechanism, second-generation vascular disrupting agent (VDA), OXi4503, in patients with solid tumors with hepatic involvement.
The multi-center study is being conducted in Australia and is expected to enroll approximately 63 patients at up to 11 sites. The study is open to patients with primary hepatocellular carcinoma, as well as patients with secondary hepatic tumor involvement. Patients participating in this dose-escalating study will be administered intravenous OXi4503 on days 1, 8 and 15 of a 28-day cycle. The open-label, dose-escalation study is designed to evaluate safety, tolerability and maximum tolerated dose (MTD), and is expected to conclude in the fourth quarter of 2009. The company expects to announce top-line data in the first half of 2010. Once MTD is determined, and depending upon the results of the Phase 1b portion of the trial, a subsequent Phase 2a portion of the trial would evaluate overall response rate to OXi4503 in patients with hepatocellular carcinoma or other advanced cancers with hepatic tumor involvement.
"We believe that Vascular Disrupting Agents are a promising new weapon in the fight against cancer. Based on preclinical animal models evaluating OXi4503 in hepatocellular carcinoma and liver metastases, and initial data from the ongoing Phase 1 study of OXi4503 in patients with advanced solid tumors, tumors in the liver may be particularly responsive to OXi4503's combination of vascular disruption and cytotoxic therapy to effect tumor death. I am pleased to be working with OXiGENE in the clinical evaluation of OXi4503, which may one day be an important therapy for patients with liver cancers," said Christopher Sweeney, M.B.B.S., Director of Cancer Clinical Department of Medical Oncology, Royal Adelaide Hospital Cancer Centre, Professor of Medicine, Discipline of Medicine, Faculty of Health Sciences, University of Adelaide and the principal investigator for this study.
"Initiating this Phase 1b/2a trial of OXi4503 represents an important step for vascular disrupting agents, and for OXiGENE," said Patricia Walicke, M.D., Ph.D., Chief Medical Officer for OXiGENE, Inc. "The trial is designed to build on the interesting data gathered from the Phase 1 study of OXi4503 in patients with advanced solid tumors, as well as from preclinical studies that demonstrated OXi4503's single-agent activity in xenograft tumor models and synergistic or additive effects in combination with chemotherapy and other treatment modalities. We expect that additional patient data will help us to further elucidate the safety and activity profile of OXi4503 and significantly advance our understanding of this promising new compound."
Clinicians and other medical professionals who would like more information about this study may contact OXiGENE at 781-547-7900.
About OXi4503
OXi4503 (combretastatin A1 di-phosphate / CA1P) is a dual-mechanism vascular disrupting agent (VDA) that is being developed in clinical trials for the treatment of solid tumors. Like its structural analog, ZYBRESTAT(TM) (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. Preclinical studies have shown that OXi4503 has (i) single-agent activity against a range of xenograft tumor models; and (ii) synergistic or additive effects when incorporated in various combination regimens with chemotherapy, molecularly-targeted therapies (including tumor-angiogenesis inhibitors), and radiation therapy. OXi4503 is currently being evaluated as a monotherapy in a Phase 1 dose-escalation trial in patients with advanced solid tumors and in a Phase 1b/2a study in patients with solid tumors with hepatic involvement. OXiGENE is developing OXi4503 under the strategic drug development partnership it established with Symphony Capital in October 2008.
About OXiGENE
OXiGENE is a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases. The Company's major focus is developing vascular disrupting agents (VDAs) that selectively disrupt abnormal blood vessels associated with solid tumor progression and visual impairment. OXiGENE is dedicated to leveraging its intellectual property and therapeutic development expertise to bring life-extending and life-enhancing medicines to patients.
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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 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, timing for results from the Phase 1b/2a study of OXi4503 in patients with solid tumors with hepatic involvement, and timing or execution of a potential strategic collaboration on any product or indication or any other transaction. 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, 2008.