OXiGENE, Inc., Waltham, Mass., a clinical-stage biopharmaceutical
company developing novel therapeutics to treat cancer and eye diseases,
announced that the company has begun dosing patients in a randomized,
double-blinded, controlled Phase II study of its potential
first-in-class vascular disrupting agent (VDA), ZYBRESTAT(tm)
(fosbretabulin), 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 (NSCLC).
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. "This study builds upon encouraging observations made in
preclinical and clinical studies suggesting that combination therapy
with ZYBRESTAT and bevacizumab results in enhanced anti-tumor activity
and prolonged tumor blood-flow inhibition," commented Patricia
Walicke, M.D., Chief Medical Officer of OXiGENE. "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 VDA and
anti-angiogenic agent combinations." Additional information
regarding the study design, enrollment criteria, and participating
centers will be available at http://www.clinicaltrials.gov (keyword:
non-small cell lung cancer).
About ZYBRESTAT (fosbretabulin)
OXiGENE believes that ZYBRESTAT is poised to become the first
therapeutic productin a novel class of small-molecule drug candidates
called vascular disrupting agents (VDAs). Through interaction with
vascular endothelial cell cytoskeletal proteins, ZYBRESTAT selectively
targets and collapses tumor vasculature, thereby depriving the tumor of
oxygen and causing death of tumor cells. In clinical studies in solid
tumors, ZYBRESTAT has demonstrated potent and selective activity against
tumor vasculature, as well as clinical activity against anaplastic
thyroid cancer, ovarian cancer, and various other solid tumors. In
clinical studies in patients with forms of macular degeneration,
intravenously-administered ZYBRESTAT has demonstrated clinical activity.
About Non-small Cell Lung Cancer
The American Cancer Society estimates that over 180,000 cancer
patients in the United States will be diagnosed with NSCLC in 2008. Lung
cancer deaths in Europe are estimated to be over 340,000 per year. Lung
cancer is the leading cause of cancer death among both men and women -
more than prostate, breast and colon cancer combined.
About OXiGENE, Inc.
OXiGENE is a clinical-stage biopharmaceutical company developing
novel small- molecule therapeutics to treat cancer and eye diseases. The
company's major focus is the clinical advancement of drug
candidates that selectively disrupt abnormal blood vessels associated
with solid tumor progression and visual impairment. OXiGENE is dedicated
to leveraging its intellectual property position and therapeutic
development expertise to bring life-saving and life-enhancing medicines
to patients.
For more information, visit http://www.oxigene.com or call call
781/547-5900.
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