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Saturday June 2, 10:01 am Eastern Time New prostate cancer drug abarelix shows benefit By Toni Clarke NEW YORK, June 2 (Reuters) - Amgen Inc. (NasdaqNM:AMGN - news) and Praecis Pharmaceuticals Inc. (NasdaqNM:PRCS - news) said latest trials show their new, jointly developed prostate cancer treatment abarelix reduced levels of testosterone, a male hormone that fuels the growth of prostate cancer cells, faster than the standard treatment. Results from two Phase III trials, the final test of a drug before it is submitted to the Food and Drug Administration for approval, demonstrated that in patients treated with abarelix, testosterone levels were reduced to a targeted level in 72 percent of patients by the eighth day of treatment. In comparison, no patients taking the standard drug, Lupron, had testosterone levels reduced to the targeted goal within the eighth day. Lupron is made by Deerfield, Illinois-based Tap Pharmaceuticals, a joint venture between Abbott Laboratories Inc. (NYSE:ABT - news) and Takeda Chemical Industries Ltd. of Japan. The drug met its primary goals of reaching the targeted reduction of testosterone in the first week of treatment, and the rapidity of achieving and maintaining suppression of the hormone, an Amgen spokeswoman said. In addition, the study found that patients treated with abarelix, whose trade name, if approved, will be Plenaxis, did not experience a surge in testosterone levels at the beginning of treatment. By contrast, 82 percent of patients treated with Lupron experienced a testosterone surge that researchers say could stimulate tumor cell growth and potentially worsen the symptoms of cancer during the first weeks of treatment. By the 85th day of the trial, however, both Lupron and abarelix had achieved about the same reduction in testosterone levels. After 85 days both patient groups achieved about the same decrease in prostate specific antigen (PSA) levels, though those treated with abarelix saw their PSA levels drop faster. PSA levels are a measure of the amount of testosterone in the blood. A second trial measured the efficacy of abarelix against a combined therapy comprising Lupron and a drug called Casodex, which is made by Anglo-Swedish AstraZeneca Plc . Casodex is used in combination with Lupron to offset the testosterone surge that Lupron can cause at the beginning of treatment. Patients treated with abarelix saw the same level of reduction in testosterone and PSA levels as those treated with the combined therapy. Side effects in both groups included hot flashes, breast enlargement, breast pain and headaches. Abarelix is the first of a new class of drugs called gonadotropin releasing hormone (GnRH) antagonists that rapidly suppress the production of testosterone and other hormones at the beginning of therapy. If approved, it could be on the market as early as June 12. quelle:http://biz.yahoo.com/rf/010602/n31701867.html gruss tb 2 |
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