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news.OXiGENE has started dosing patients in a randomized, double-blinded, controlled Phase II study of its potential first-in-class vascular disrupting agent Zybrestat, in combination with the anti-angiogenic drug, bevacizumab, and the chemotherapeutic agents carboplatin and paclitaxel as first-line therapy for patients with Stage IIIb/IV non-small cell lung cancer.
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The multi-center study is being conducted in the US and India and is expected to enroll approximately 60 patients at 14 sites. Half of the patients will be administered intravenous Zybrestat plus bevacizumab, carboplatin and paclitaxel, and half will receive the standard first-line regimen of a combination of bevacizumab, carboplatin and paclitaxel.
The primary outcome of the trial will be a comparison of safety and progression-free survival between the two treatment arms. The study design also includes analysis of tumor response rate as measured by Recist criteria. The anticipated duration of the study is 24 months, and the company expects to announce top-line data in the second half of 2009.
Patricia Walicke, chief medical officer of OXiGENE, said: “We’re optimistic that this study will provide further support for this combination in the treatment of non-small cell lung cancer, and more generally for the paradigm of anti-vascular therapy with vascular disrupting agent and anti-angiogenic agent combinations.”