OXiGENE, Inc.
OXGN, a biopharmaceutical company developing novel cancer
therapeutics, today announced that the first patient has been enrolled in a
Phase 2 study to evaluate the safety and activity of fosbretabulin monotherapy
in patients with locally advanced, recurrent or metastatic gastrointestinal
neuroendocrine tumors, or GI-NETs, with elevated biomarkers. GI-NETs are
slow-growing, often invasive tumors that produce excessive amounts of hormones
and other peptides which enter the blood stream and cause debilitating
symptoms.
"Based on our preclinical NET study which showed a statistically significant
decrease in a relevant biomarker when treated with fosbretabulin, this study
of fosbretabulin in GI-NETs is a potentially meaningful advance, as these
tumors are increasing in incidence and very few treatment options exist beyond
surgery or radiation," said Steven K. Libutti, MD, FACS, Professor of Surgery
and Genetics, Albert Einstein College of Medicine, and Montefiore Medical
Center. "Fosbretabulin's unique mechanism of action specifically targets the
tumor vasculature in order to cut off the blood supply at the tumor's core,
which may result in reduction in biomarkers and symptoms for these patients.
We are hopeful that this novel approach may be effective in reducing the
debilitating symptomatology of this cancer."
The Phase 2 study will evaluate the safety and activity of fosbretabulin
monotherapy in approximately 20 GI-NET patients with increased biomarkers
and/or clinical symptoms. The study will evaluate the impact of fosbretabulin
on certain biological mediators over time, following the patient's baseline
measurements at the study start. The primary endpoint of the trial is the
reduction of biomarkers, and secondary endpoints include improvement in
symptoms and quality of life as assessed by validated measures. The study will
be conducted at five sites in the U.S.
"We are pleased to add GI-NET as a new tumor type that may benefit from
treatment with fosbretabulin given the significant need for alternative new
treatment options in patients with these tumors," said Dai Chaplin, president
and chief executive officer at OXiGENE. "We hope to build on the growing body
of evidence suggesting fosbretabulin's meaningful biological activity in
various indications. We look forward to enrolling this important study and
obtaining the data to evaluate the potential of this novel treatment approach
for patients with GI-NETs."
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