Deaths lead to reduction in experimental lung cancer drug dosage
Tuesday, October 21st 2003, 12:00 am
By: News On 6
SEATTLE (AP) _ The maker of an experimental lung cancer drug said it lowered the dosage used in clinical trials after a few gravely ill patients taking the drug died earlier than expected.
In a news release and conference call with analysts Monday, Cell Therapeutics Inc. officials said fewer than 10 patients had died after their infection-fighting white blood cells were destroyed in the tests. Company officials would not give the exact number of deaths.
The patients who died had a median life expectancy of 10 weeks; the company did not say at what point in their treatment they died. It also would not say how many more patients died while being administered the experimental drug, Xyotax, compared with those who received standard chemotherapy.
CTI cut the dosage of its drug at the recommendation of an independent safety monitoring board.
``In ethical pharmaceutical drug development, you (lower the dose),'' CTI chief executive Dr. James A. Bianco told analysts. ``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.''
CTI is spending millions on trials intended to prove that Xyotax is safer and more effective than Taxol in fighting non-small cell lung cancer.
Following the announcement, CTI stock fell 15.6 percent to $9.06 on the Nasdaq Stock Market Monday.
Bianco said the trial may still be used as the basis for approval from the Food and Drug Administration if Xyotax is shown to prolong lives.
He said the company still expects to complete enrolling about 1,600 patients late this year and early next year for three Xyotax trials at more than 100 sites in the United States, Europe and Latin America.
Even at the lower dose, Xyotax should be potent enough to prolong lives, Bianco said. In a smaller trial, severely ill patients on the lower dose survived for a median of 22 weeks, compared with 10 weeks on Taxol.
Dr. Scott Stromatt, CTI vice president of clinical development, said the deaths were not confined to any particular trial location but blamed some on problems in Latin America.
Some patients in Latin America traveled long distances to receive Xyotax, returned home, became ill and visited local doctors who did not provide proper treatment for their dwindling white blood cell counts, Stromatt said.