Opaxio (XYOTAX) - New FDA Date for Cell Therapeutics: media item

Note: Lots of unanswered questions

"....Meantime, Cell Therapeutics also disclosed another setback for its experimental cancer drug Opaxio. The Gynecologic Oncology Group (GOG) turned down Cell Therapeutics' request to conduct an interim analysis of the phase III study of Opaxio in patients with advanced ovarian cancer,
according to Cell Therapeutics annual report.....Cell Therapeutics had been telling investors as late as the company's Feb. 11 conference call to expect the results from this interim analysis from the Opaxio study later this year. GOG did not provide a reason for why the interim analysis request was denied, said a spokesman for Cell Therapeutics. GOG now plans to conduct an interim analysis of overall survival from the study in 2011, according to Cell Therapeutics. Started five years ago, the phase III study of Opaxio in ovarian cancer has enrolled only 600 out of a planned 1,100 patients. A Cell Therapeutics' spokesman would not say if the company plans to halt enrollment in the Opaxio ovarian cancer study now that the early interim analysis off the table. By the way, last September, Cell Therapeutics trumpeted in a press release the news of the Opaxio ovarian cancer study reaching the 600-patient enrollment milestone and plans for the interim analysis with GOG. Yet Cell Therapeutics chose not to issue another press release disclosing GOG's vote to deny the company's request for an early interim analysis. Instead, Cell Therapeutics only disclosed the bad news in its annual report filed with the SEC."