FALCON Study - Fosbretabulin Advanced Lung Combination for Oncology

OXiGENE is conducting a Phase II randomized, controlled study dosing patients with ZYBRESTAT™ (fosbretabulin) in combination with the anti-angiogenic drug, bevacizumab, and the chemotherapeutic agents carboplatin and paclitaxel, as a first-line therapy for patients with Stage IIIb/IV non-small cell lung cancer (NSCLC).

The FALCON study is expected to enroll approximately 60 patients at 14 sites in the US. Half of the study patients will receive ZYBRESTAT plus bevacizumab, carboplatin and paclitaxel administered intravenously; the other half will receive the standard first-line regimen of a combination of bevacizumab, carboplatin and paclitaxel.

The primary objective of the FALCON study is to compare the safety, overall survival and progression-free survival of the two treatments. The study will also include an analysis of tumor response rates as measured by RECIST criteria.

In November 2009, at the AACR-NCI-EORTC meeting, OXiGENE presented safety and early efficacy data from a planned interim analysis from this trial showing that the combination appeared to be well-tolerated, and that there were no significant overlapping toxicities with Avastin. Most notable and encouraging was the observation that 5 of the 6 patient deaths during the evaluation period were due to disease progression and occurred in the control arm. The company believes that these early signs of activity support previous data showing that ZYBRESTAT is an active antitumor agent.

The FALCON study marks the first time that a vascular disrupting agent, such as ZYBRESTAT, has been combined at full strength with an anti-angiogenic agent against a background of chemotherapy. OXiGENE anticipates presenting an analysis of the activity and tolerability of this novel combination at ASCO in June 2010.