LONDON - Antisoma plc received a strong recommendation that it should recommence recruitment into its Phase III study of Theragyn in ovarian cancer, from the independent safety committee overseeing the trial.
Recruitment was halted following a poster presentation at the American Society of Clinical Oncology meeting of a study that hinted at a survival benefit among the control group. The study, by Steven Nicholson, a registrar at St. George's Hospital, Tooting, London, was not part of Antisoma's development program, but it used the same radiolabeled antibody. The company, based in London, was unaware of the Nicholson study until it was published.
At its regular quarterly meeting last Wednesday, the safety committee reviewed all currently available data from Antisoma's study and from the Nicholson study. The committee recommended the conduct of the study should not be changed and that recruitment be resumed.
Shares in Alizyme fell 60.5 pence to 90 pence when the company announced it was suspending recruitment to the trial on May 22. The price drifted further down to close at 72 pence on Thursday, but was up 23 percent at 88.5 when the safety committee's recommendation was announced Friday.
Antisoma has asked the charity, the Imperial Cancer Research Fund (ICRF), to organize an independent review of the Nicholson study. The ICRF licensed Theragyn to Antisoma, and also provided the radiolabeled HMFG1 murine monoclonal antibody to Nicholson.
While Antisoma was cheered by the recommendation of the safety committee, it said it would not recommence recruitment until it had the findings of the Nicholson study review.