OXiGENE (OXGN) Offers Results Showing Median, One-Year Survival Improvement in Thyroid Cancer Patients Using ZYBRESTAT and Chemo

April 30, 2012 12:35 PM EDT
OXiGENE, Inc. (Nasdaq: OXGN) announced today that data were presented from a pre-specified subgroup analysis of the FACT trial, a randomized, controlled Phase 2/3 study of ZYBRESTAT® (fosbretabulin tromethamine, CA4P) in patients with anaplastic thyroid cancer (ATC), at the 2012 Annual Meeting of the American Association of Endocrine Surgeons (AAES). A subgroup analysis compared patients on the FACT study who underwent prior cancer-related surgery (thyroidectomy) followed by fosbretabulin and chemotherapy to patients without surgery who received chemotherapy alone. The results showed that improvements were observed in median survival and one-year survival for patients with prior thyroidectomy followed by fosbretabulin and chemotherapy.

This subgroup analysis of the FACT trial compared patients with prior cancer-related surgery (thyroidectomy) to patients without prior cancer-related surgery. Key data points from this analysis are as follows.
  • Patients who had prior surgery and then received ZYBRESTAT tended to live longer than patients who had prior surgery without receiving ZYBRESTAT.
  • Median survival for patients without surgery was similar for patients on both arms of the study.
  • The percentage of patients without surgery who survived at one year was greater in the ZYBRESTAT arm (16.7%) than in the control arm (10.0%).
  • Patients with more extensive surgery (total/near-total thyroidectomy) who received ZYBRESTAT tended to live longer than those who did not have surgery and received ZYBRESTAT, and lived longer than all patients on the control arm of the trial regardless of the extent of surgery.
  • Median survival for patients with total/near-total thyroidectomy was 10.0 months on the ZYBRESTAT arm and 4.0 months on the control arm.
  • Survival at one year was 35.0% on the ZYBRESTAT arm and 10.0% on the control arm.
  • Younger patients (≤ 60 years) who had cancer-related surgery and received ZYBRESTAT tended to survive longer than younger patients on the control arm (10.9 months vs. 6.8 months) respectively.
OXiGENE is planning to conduct a pivotal Phase 3 registration study of ZYBRESTAT in patients with ATC. The Company is in the process of pursuing a Special Protocol Assessment with the US Food and Drug Administration (FDA) for this planned trial. The Company is also pursuing strategies to obtain funding with which to conduct this trial. OXiGENE's goal is to be in position to initiate the FACT 2 trial in late 2012.


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