- The Washington Times - Tuesday, February 11, 2003

ABBOTT PARK, Ill., Feb. 11 (UPI) — Abbott Laboratories said Tuesday it has ended a clinical trial for its experimental end-stage prostate cancer drug, atrasentan, because it failed to slow progress of the disease.

Atrasentan is one of the next generation drugs considered more targeted than chemotherapy, which kills healthy cells along with cancerous ones. The drug, which was in its Phase III clinical trial, was seen as more convenient than conventional chemotherapy injections since it is taken daily in pill form. It had been considered a linchpin in the company's anti-cancer arsenal.

Atrasentan works by blocking the effects of the protein endothelin, which can stimulate the growth of cancer cells. Early results indicated the drug did not interfere with testosterone production as some other cancer drugs do although some patients complained of headaches, swelling and sinus trouble.

The trial, which involved more than 800 patients in a double-blind study, was the last major step before seeking Food and Drug Administration approval. Abbott had hoped for FDA approval by late next year.

"The study did not meet its primary endpoint of time-to-disease progression, and therefore will be stopped," Abbott said. "The majority of patients who completed the trial did so within three months of starting treatment. These results in both the placebo and atrasentan arms are consistent with the rapid progression of bone disease in this end-stage patient population."

Progression of the disease to the bone leads to almost certain death.

"We entered these trials knowing there is no effective therapy for these very sick, end-stage prostate cancer patients," said Dr. Perry Nisen, Abbott vice president of global oncology development.

Abbott said it's still possible Atrasentan could be effective in treating prostate cancer at an earlier stage or as a treatment for other cancers, including renal cell carcinoma, ovarian, breast, brain, colorectal and non-small-cell lung cancers.

"We learned a great deal from this study," Nisen said. "The effects on PSA (prostate-specific antigen) levels and bone markers strengthen our belief about Atrasentan's potential benefit in prostate cancer and other tumor types, which are the focus of our other ongoing and future studies."

More than 1 million men have been diagnosed with prostate cancer, with about 30 percent developing incurable metastatic cancer, making prostate cancer the second leading cause of death in men.

Abbott said the end of the trial would have no effect on 2003 and 2004 earnings.

In a related announcement, Democratic presidential hopeful, Sen. John Kerry of Massachusetts, said Tuesday he will undergo surgery for prostate cancer on Wednesday.

Dr. Patrick Walsh, a urologist at Johns Hopkins Hospital in Baltimore, told CNN Kerry, 59, has "a very early, curable" form of cancer. Kerry's father died of prostate cancer.




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