OXiGENE has initiated a Phase Ib/IIa study of its dual-mechanism, second-generation vascular disrupting agent, 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 one, eight 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 Ib portion of the trial, a subsequent Phase IIa portion of the trial would evaluate overall response rate to OXi4503 in patients with hepatocellular carcinoma or other advanced cancers with hepatic tumor involvement.
Patricia Walicke, chief medical officer of OXiGENE, said: The trial is designed to build on the interesting data gathered from the Phase I 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.