TRIAL FAILURE

[RandyW]

Key trial of Cell Therapeutics lung cancer drug ends

By Luke Timmerman

Seattle Times business reporter

Cell Therapeutics said late Thursday it has shut down its most important clinical trial because patients who took its cancer drug were dying more quickly than those receiving a standard chemotherapy drug.

The Seattle biotech company, which suspended the trial a month ago, will submit a newly designed study to the Food and Drug Administration by year's end. The company said data from the 200 patients who were treated so far will not be used if it eventually seeks FDA approval for the drug, called Xyotax.

The trial, called Pioneer, had the unusual feature of being limited exclusively to women with lung cancer.

Cell Therapeutics originally planned to enroll 600 at 170 medical centers. Patients in the study had advanced lung cancer and a life expectancy of 8 to 10 weeks.

Dan Eramian, a company spokesman, said patients taking the company's drug lived about as long as expected based on earlier studies, but patients in the control group lived unusually long.

He said the company has ruled out the possibility that contamination or toxicity from its drug might be killing patients prematurely, and the difference remains unexplained.

The drug already has failed three major lung cancer trials that enrolled both men and women, but the company said it isn't giving up on Xyotax.

Eramian said the company plans to test the drug in 300 women, but only in women with normal estrogen levels.

The company said that the new design is based on experience in earlier studies. Xyotax, a polymer molecule that modifies chemotherapy to make it more tolerable, is believed to react positively with estrogen.

In the next study, the company hopes it will show its drug provides a survival advantage, so it can win approval for the market.

"You need to go to the FDA with something you can win with," Eramian said.

The trial shutdown will put the company at least six months behind its schedule for completing the trial, Eramian said.

That will cost the company precious time and money. In its last quarterly report, Cell Therapeutics said it had $68 million in cash at the end of September, and it subsequently received a $15 million payment from its partner Novartis.

Cell Therapeutics, which has never turned a profit in its 15-year history, is spending money at a rate of close to $10 million a month.

Xyotax isn't its only drug. Cell Therapeutics also expects to receive results in the first half of 2007 from a study of another drug, Pixantrone, for non-Hodgkin's lymphoma.

Cell Therapeutics stock closed down 7 cents Thursday to close at $1.82 a share.

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