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news.OxiGENE has unveiled initial data from a Phase 1b/2 study of its lead investigational drug, CA4P, in combination with the anti-angiogenic agent Votrient (pazopanib) in patients with advanced recurrent ovarian cancer.
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Under the PAZOFOS randomized, controlled clinical study, OxiGENE plans to enroll up to 128 patients at up to ten sites in the UK.
It includes a phase 1b dose escalation portion (CA4P plus pazopanib) and a phase 2 portion comparing CA4P plus pazopanib versus pazopanib alone.
The primary endpoint for the phase 2 part is progression-free survival. Secondary endpoints include safety, overall survival, objective response rate and relevant biomarkers.
The company enrolled 12 patients in the phase 1b portion of the study. Nine of them were evaluated for objective response using RECIST criteria, demonstrating two partial responses, five stable diseases and two progressive diseases.
Eight of the ten subjects with evaluable data showed decreases in the tumor marker CA125, with three achieving a response according to CGIC criteria.
Safety data indicated that the combination of CA4P and pazopanib was generally well tolerated with no Grade 4-5 adverse events (AEs). Hypertension, fatigue, and pain were the most commonly reported AEs
OXiGENE president and CEO William Schwieterman said: "The results seen thus far with CA4P combined with pazopanib broaden and strengthen the body of evidence indicating that CA4P can be effectively used as a component of combination therapy for patients with solid tumors.
"We look forward to the continued results from this trial, and to advancing CA4P in combination with Avastin in phase 2/3 studies in platinum-resistant ovarian cancer and glioblastoma multiforme in 2016."
CA4P targets an established tumor’s immature endothelial cells within the tumor’s blood vessels, consisting of the tumor vasculature. It results in the widespread ischemia and necrosis of the cells within the central core of the tumor.
OXiGENE plans to advance CA4P in clinical development in combination with approved anti-angiogenic agents which avoid the growth of new tumor blood vessels.
The company plans to start two late-stage clinical programs for CA4P in 2016.