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news.Goodwin Biotechnology and Menarini Group say they have completed the manufacture of monoclonal antibody abagovomab, the active principle of the Menarini ovarian cancer vaccine, to be used in phase III clinical studies around the world.
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The monoclonal antibody, produced by GBI to standards fully compliant with both US and European requirements, will be used to kick off the initial phase of a multicenter trial.
Abagovomab will be administered as a maintenance therapy, after surgery and first line platinum and taxane chemotherapy with the aim of preventing the reappearance of tumors and prolong survival. Around 900 women will be enrolled in the study throughout the world (US, Germany, Italy, Poland, Czech Republic, Spain, Hungary and Belgium).
Andrew Slade, Menarini biotech managing director, said: “We now hope abagovomab will help the over 200,000 women attacked by ovarian cancer every year in the world.”