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AMGEN'S CANCER DRUG TESTING WELL.

Byline: Jason Z. Cohen Staff Writer

THOUSAND OAKS - Amgen Inc. presented promising new data from trials of its prostate cancer drug to doctors attending the American Society of Clinical Oncology on Tuesday.

The company has completed Phase III clinical trials for Abarelix, a drug it developed in partnership with Praecis Pharmaceuticals.

Phase III is the final phase of studies before it prepares to submit the drug for Food and Drug Administration review.

Jay Silverman, an analyst for FleetBoston Robertson Stephens Inc., predicts Amgen will submit to the FDA its application for approval of Abarelix by the end of the year.

The market for hormone-suppressing drugs such as Abarelix is believed to be $2 billion annually, said Amgen spokesman David Kaye.

The drug also is being tested as a treatment for endometriosis, a hormone-induced condition in which cysts form in the uterus.

Abarelix suppresses the release of the hormone testosterone, which helps prostate cancer tumors grow. Current drugs for testosterone suppression cause an initial surge in the level of testosterone, which can cause tumors to grow, Dr. David McLeod, one of the physicians conducting trials on Abarelix, said in a company statement.

``Physicians are concerned about the risk that cancer of the prostate could worsen during the surge in testosterone that accompanies currently available hormonal drugs,'' said McLeod, director of urologic oncology at Walter Reed Medical Center in Washington.

The company presented the results of two Phase III studies comparing Abarelix to existing prostate cancer drugs. The first study, conducted by McLeod on 255 patients, compared Abarelix with the combination of leuprolide and bicalutamide, the current hormonal therapy.

In the study, 68 percent of the Abarelix patients showed significant drops in their testosterone levels after a week of treatment, compared with none under the existing treatment.

In the second study, conducted by Dr. John Trachtenberg of Princess Margaret Hospital in Toronto, 72 percent of the Abarelix patients had lowered testosterone compared with none of those being treated with leuprolide.

``Testosterone is the male hormone, and it's known to be involved in the spread of prostate cancer,'' Kaye said. ``In patients who have hormone-responsive prostate cancer, meaning the type that's spread by testosterone, what you want to do is shut off the hormone.''
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Title Annotation:Business
Publication:Daily News (Los Angeles, CA)
Geographic Code:1USA
Date:May 24, 2000
Words:371
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