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Pharmacyclics cancer drug fails to prove effective (Reuters Securities) Drug developer Pharmacyclics Inc. on Thursday said its lead cancer drug, Xcytrin, failed to prove effective in the treatment of brain metastases, cancer that has spread to the brain from another part of the body. - Dec 13 8:26 PM ET


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Website: http://biz.yahoo.com/rf/011213/n13131062_1.html

Posted on: 12/14/2001

Pharmacyclics cancer drug fails to prove effective

LOS ANGELES, Dec 13 (Reuters) - Drug developer Pharmacyclics Inc. (NasdaqNM:PCYC - news) on Thursday said its lead cancer drug, Xcytrin, failed to prove effective in the treatment of brain metastases, cancer that has spread to the brain from another part of the body.

The company's shares, which lost $1.33 to close at $21.70 on Nasdaq before the trial results were announced, fell to $10.20 in after hours trading on Instinet.

The pivotal-stage trial of 401 patients at more than 50 cancer centers in the United States, Canada and Europe was designed to compare the safety and effectiveness of standard whole brain radiation therapy to standard radiation plus Xcytrin.

Xcytrin is the first in a new class of experimental drugs called texaphyrins that are believed to work by disrupting cellular metabolism in cancer cells, making the diseased cells more responsive to cancer-killing radiation and chemotherapy.

Pharmacyclics, based in Sunnydale, California, said the drug did not have a statistically significant impact on the study's main goals of increased survival and time to neurologic progression of the cancer, but it did show that the drug was clinically active, especially in lung cancer patients.

"Median survival was 5.2 months for all patients treated with Xcytrin plus radiation therapy compared to 4.9 months for control patients receiving radiation alone. Median time to neurologic progression for all patients treated with Xcytrin plus radiation therapy was 9.5 months compared to 8.3 months for those patients receiving radiation alone. Neither of these endpoints reached statistical significance," the company said.

"Although the study did not achieve statistical significance on the primary endpoints, the effect in the largest predefined subgroup of patients, those with lung cancer, supports the activity of the drug and indicates that Xcytrin may increase the local control of radiation therapy," Dr. Richard Miller, Pharmacyclics chief executive, said on a conference call.

Miller said that if the complete findings, including analysis of the trial's secondary goals, are consistent with initial study results, Pharmacyclics intends to talk with the U.S. Food and Drug Administration about filing a new drug application.

The company is also studying Xcytrin for other potential indications, including primary brain tumors and non-small cell lung cancer.

Results from a mid-stage trial of the drug in patients with primary brain cancer will be available in the first part of next year, Miller said.



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