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Tuesday, October 21, 2003 - Page updated at 12:00 A.M.

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Cancer-drug trial reports deaths; Cell Therapeutics cuts dose

By Luke Timmerman
Seattle Times business reporter

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Cell Therapeutics is switching several hundred severely ill patients to a lower dose of its experimental drug for lung cancer after it said it saw "a handful" of early deaths in patients whose infection-fighting white blood cells were wiped out.

The Seattle biotech company would not disclose the exact number of early deaths, saying only that it was fewer than 10. It would not say how many more patients died on its drug, Xyotax, compared with the arm of the study in which patients took a form of standard chemotherapy.

The company said it made the decision after an independent safety monitoring board recommended it reduce the dose.

The news was a setback for a company that is spending millions on trials in which it hopes to prove that Xyotax is safer and more effective than Taxol, a blockbuster cancer drug. After the news yesterday, the company's stock fell $1.67, or 15.6 percent, to $9.06.

Despite the deaths, which the company described vaguely as "neutropenic-related toxicities" in its news release, Chief Executive James Bianco included more positive information during a conference call with analysts.

Bianco said the trial can still be used as the basis for approval from the Food and Drug Administration if the drug can prolong lives.

He said the company's three pivotal Xyotax trials are still on track to finish enrolling about 1,600 patients late this year and early next year.

The fatally low white-blood-cell counts, Bianco said, occurred among the sickest of those with lung cancer, a patient group expected to live a median of 10 weeks.

"In ethical pharmaceutical drug development, you (lower the dose)," Bianco said. "You don't care what the stock market thinks. You don't care what reporters think. You do what's right for the patient. We did the right thing."

Even at the lower dose, Bianco said the company still believes its drug is potent enough to prolong lives. In a smaller trial, severely ill patients on the lower dose survived for a median of 22 weeks, compared with 10 weeks on Taxol.

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Xyotax also has shown fewer side effects, with patients seeing less nerve damage and hair loss.

The drug works by attaching a polymer to the active ingredient in Taxol that helps the toxic load reach tumors.

The FDA has given the drug a "fast track" designation, which helps speed up the regulatory review process.

"We're more bullish than ever," Bianco said on the conference call.

Dr. Jack Singer, head of research, said company officials talked extensively about whether to try the higher dose of Xyotax in its largest trial. They chose to proceed because it had been shown to be safe in an earlier trial, and some leading oncologists encouraged it as a way to boost the drug's effectiveness rate, Singer said.

Dr. Scott Stromatt, vice president of clinical development, said the deaths were not confined to any particular place in the company's trials, which are spread among more than 100 sites in the United States, Europe and Latin America. He attributed the deaths of some patients in Latin America to substandard care.

Specifically, Stromatt said, some patients in Latin America traveled long distances to receive Xyotax. When they became ill and visited their local doctors, they were not properly treated for their plummeting white-blood-cell count.

The company has suspended enrollment at several trial sites to make sure they strictly follow the study protocol, Stromatt said.

Chemotherapy patients in the U.S. rarely die of complications from low white-blood-cell counts because they are tested and treated for that side effect.

Stromatt said one of the problems was that patients' low white-blood-cell counts weren't being detected. To solve that, the trial will test patients one week after they receive treatment, when counts typically are at their lowest.

Quynh Pham, an analyst with Delafield Hambrecht, said the market over-reacted, because the deaths were not seen in all three of the Xyotax lung-cancer trials. Pham does not own the stock and rates the company a "buy."

"In theory, you'd think they'd want to use the highest dose levels because, in theory, the patients should do better," Pham said.

Luke Timmerman: 206-515-5644 or ltimmerman@seattletimes.com

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