OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, announced today that it presented updated safety and clinical activity data from the FALCON trial, a randomized, controlled Phase 2 study of ZYBRESTAT(TM) (CA4P) in patients with non-small cell lung cancer (NSCLC). The updated analysis showed that the median time to progression for patients receiving ZYBRESTAT plus bevacizumab and chemotherapy was 9.5 months, compared with a median time to progression of 8.8 months for patients receiving bevacizumab and chemotherapy alone. Of the patients in the study arm (ZYBRESTAT combined with bevacizumab and carboplatin/paclitaxel chemotherapy), 50% achieved a partial response, compared with the control arm (bevacizumab and chemotherapy) of the trial, where only 38% of patients achieved a partial response. The combination regimen including ZYBRESTAT was observed to be well-tolerated with no significant cumulative toxicities when compared with the control arm of the study.
The data were presented in a poster session at the 22nd EORTC-NCI-AACR symposium on "Molecular Targets and Cancer Therapeutics" in Berlin, Germany. The poster was titled, " Randomized Phase 2 Trial of a Vascular Disrupting Agent (VDA) Fosbretabulin Tromethamine (CA4P) with Carboplatin, Paclitaxel and Bevacizumab in Stage IIIB/IV Non-Squamous Non Small Cell Lung Cancer (NSCLC): Analyses of Safety and Efficacy," by Edward Garon, M.D., Assistant Professor of Medicine at the University of California, Los Angeles and principal investigator of the study.
"The FALCON study interim data continues to be encouraging, suggesting that ZYBRESTAT is a well-tolerated drug that has the potential to result in better patient outcomes than standard therapy," commented Dr. Garon. "This updated data provides additional support for a possible registration study investigating ZYBRESTAT as a treatment for patients with NSCLC."
"The results from the FALCON study continue to show that ZYBRESTAT appears well-tolerated and suggest improved progression free survival and response rate in NSCLC patients," commented Peter Langecker, M.D., Chief Executive Officer at OXiGENE. "While these data must accrue for several more months before we can truly analyze the overall survival benefit to patients, we believe that the continued trends of the FALCON study, which come on the heels of our positive data from a study of patients with anaplastic thyroid cancer, shows that ZYBRESTAT may hold promise as a future treatment for cancer patients."
FALCON is a randomized controlled study investigating the addition of ZYBRESTAT (fosbretabulin tromethamine, or CA4P) to standard therapy (carboplatin, paclitaxel, and bevacizumab) in patients with Stage IIIb or IV non-squamous NSCLC. A total of 60 patients were treated with study medication, including 29 in the standard therapy arm and 31 in the CA4P + standard therapy arm. The treatment arms were well balanced with respect to baseline characteristics, except for a greater percentage of males in the CA4P arm. Disease was predominately Stage IV in both arms. Patients received CA4P plus standard therapy or standard therapy alone every 21 days for up to 6 cycles (treatment phase). Patients without disease progression after 6 cycles could continue to receive bevacizumab with or without CA4P (depending on treatment arm) until disease progression (maintenance phase).
Key data points from the ongoing FALCON trial are as follows.
Progression-free survival (PFS)
- PFS determined by RECIST criteria
- Median PFS was 9.5 months in the CA4P arm versus 8.8 months in the standard therapy arm (hazard ratio (95%CI) = 0.73 (0.33, 1.62))
- PFS represents a 27% reduction in the odds of progression for patients receiving CA4P vs. standard therapy
Best Overall Tumor response
- Partial Response (PR) was 50% in the CA4P arm and 38% in the standard therapy arm
A copy of the EORTC-NCI-AACR presentations will be available on OXiGENE's website at www.oxigene.com.