US-based biopharmaceutical firm OXiGENE has started enrolling patients in a Phase Ib/II clinical trial designed to assess fosbretabulin in combination with Votrient (pazopanib) to treat patients with recurrent ovarian cancer.
Fosbretabulin is a vascular disrupting agent (VDA), which blocks blood flow to established tumour blood vessels and it currently being assessed as a potential treatment for solid tumours.
The randomised, controlled clinical trial includes a Phase Ib dose escalation portion with the combination of fosbretabulin and pazopanib and a Phase II portion, which compares fosbretabulin and pazopanib versus pazopanib alone.
Around 128 patients will be enrolled in the trial, whose primary endpoint is progression-free survival and secondary endpoints include safety, overall survival, objective response rate and relevant biomarkers.
Mount Vernon Cancer Centre Medical Oncology director and chief investigator for the trial Gordon Rustin said: "This study is an important first step to evaluate the potential combination of a vascular disrupting agent (VDA) with an oral anti-angiogenic agent.
"Recent clinical data suggest that combining fosbretabulin with the anti-angiogenic agent bevacizumab may provide a complementary effect in ovarian cancer patients, and we are hopeful to see a positive result in this new study that would further advance non-chemotherapeutic treatment approaches for patients with relapsed ovarian cancer."
The trial is sponsored by The Christie Hospital NHS Foundation Trust and coordinated by the Manchester Academic Health Science Centre, Trials Coordination Unit (MAHSC-CTU) with additional support from The University of Manchester, the Royal Marsden NHS Foundation Trust and Mount Vernon Cancer Centre.
Fosbretabulin and pazopanib are being provided by OXiGENE and GlaxoSmithKline (GSK), respectively.
OXiGENE CEO Dai Chaplin said: "We are delighted to support this important study, along with others, as it provides OXiGENE an important development opportunity in Europe and delivers on our strategy to leverage collaborations that advance the clinical knowledge about fosbretabulin."
Image: Intermediate magnification micrograph of a low malignant potential (LMP) mucinous ovarian tumour. H&E stain. Photo: courtesy of Nephron.