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Cell Therapeutics Looks to Pick up the Pieces After FDA Smacks Down Lymphoma Drug

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at least as long to review applications as their U.S. counterparts, meaning that even in a best-case scenario, in which the EU looks favorably on data that the FDA advisory panel shot down, pixantrone wouldn’t likely start generating sales in Europe until mid-2011.

Paclitaxel poliglumex (Opaxio). This was once Cell Therapeutics’ lead treatment in development, formerly known as Xyotax. The drug is designed to combine a common chemotherapy drug with a polymer that’s supposed to keep it stable in the bloodstream so it minimizes side effects, then gets absorbed into tumors, where it drops its toxic cell-killing payload. This drug failed to show it could help lung cancer patients live any longer in a string of three pivotal clinical trials that enrolled 1,700 patients combined.

Anyone who invested back in the Xyotax days will remember the pain when the stock rose to more than $10 in anticipation of positive results, and then collapsed when the first pivotal trial failed. Here’s a story I wrote for The Seattle Times in May 2005 when this data underwhelmed researchers during a presentation at the American Society of Clinical Oncology. When the company tried to resurrect the drug a year later, it fell flat again. By November 2006, Cell Therapeutics halted enrollment of female patients in a trial called Pioneer after patients on the drug appeared to be dying at a faster rate than those in the control group.

Despite that string of failures, the polymerized paclitaxel isn’t completely finished. It is now being tested in a pivotal trial that’s outside the control of the company, under the purview of the Gynecologic Oncology Group, a physician-based collaborative. This trial, called GOG0212, has enrolled 600 out of a planned 1,100 patients, the company said in its annual report.

Whether this trial can ever generate statistically valid results is unclear. This study began back in March 2005 and was supposed to be completed by April 2008, according to a posting on clinicaltrials.gov. The slow pace of enrollment in the pixantrone trial, and its ultimate inability to recruit enough patients, was one of the major objections the FDA and its advisory panel raised to pixantrone. The company has asked the physician group to speed things up by performing an interim analysis to see if the drug had a decent chance of hitting its goal of helping patients live longer, but the request was denied, according to the annual report. Cell Therapeutics has also planned to discuss the parameters of a pivotal trial of the polymer paclitaxel in esophageal cancer patients in 2010.

None of that sounded promising to Miller.

“That’s a dead drug,” he says.

Brostacillin. This is a small-molecule chemotherapy drug developed by a Cell Therapeutics subsidiary, Systems Medicine, based on a genomics approach. It has been studied in 230 patients to date, the company said in its annual report. One mid-stage study of the drug in patients with relapsed forms of sarcoma met its goals, and led to another mid-stage study being conducted by a European physician group. Results from that second trial are expected sometime in 2010.

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