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OXiGENE (OXGN) Begins Phase 2 Study of Fosbretabulin in GI-NETs

September 17, 2014 4:03 PM EDT

OXiGENE, Inc. (Nasdaq: 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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