To: SPSEIFERT who wrote (19380 ) 4/22/1998 8:03:00 AM From: Henry Niman Respond to of 32384
This article may shed some light on SERM-3: Raloxifene May Cut Breast Cancer Risk NEW YORK (Reuters) -- Preliminary reports suggest that raloxifene, a drug used to prevent osteoporosis in postmenopausal women, may also prevent breast cancer. These reports come 2 weeks after researchers announced that tamoxifen, a drug used in breast cancer patients, appeared to reduce the risk of breast cancer in women at high risk by 45%. But tamoxifen carries risks of serious side effects, including endometrial cancer. According to the reports on raloxifene, it is as effective as tamoxifen in preventing breast cancer, but has not been linked to an increased risk of endometrial cancer. The data were supposed to be kept under wraps until the second week in May when the full study is scheduled to be presented during the 34th annual meeting of the American Society of Clinical Oncology (ASCO), due to be held in Los Angeles, California. However, reports linking the drug to reduced risk of breast cancer were published in The Wall Street Journal on Monday and in the Tuesday edition of The New York Times. Raloxifene, a selective estrogen receptor modulator (SERM), is marketed under the name Evista. The drug's manufacturer, Eli Lilly and Company, is telling the media that they will not comment on the studies until they are officially presented at ASCO in May. ''We cannot talk specifically about these data due to ASCO's embargo limitations,'' according to a statement from Lilly. Angela Sekston, a spokesperson for Lilly told Reuters Tuesday, ''We are encouraged by the data we have to date (and) we look forward to presenting the information in the appropriate forum at (ASCO).'' In the statement, Lilly revealed that nine studies involving over 10,000 postmenopausal women have shown that those taking the drug ''had significant reductions in the incidence of newly-diagnosed breast cancers.'' ''The ASCO presentations will provide scientific data to support the possible role of Evista in preventing breast cancer among postmenopausal women. Proof of this concept will await the development of more long-term data on Evista,'' according to the press release from the Indianapolis-based pharmaceutical company. As reported by Reuters in March, a Lilly researcher has said that fewer breast cancer cases have been noted in women taking raloxifene compared with those taking placebo. Speaking at the American Cancer Society's Science Writers Seminar in Newport Beach, Dr. Kapil Dhingra also discussed an experimental drug called LY353381.HC1. In animal studies, this drug has been shown to bind to estrogen receptors 10 times more strongly than raloxifene, and appears to be even more effective in preventing cancer. More studies of this drug are underway, but results on its role in preventing cancer may take 5 to 10 years. Lilly is also about to begin a large study to assess if Evista can prevent heart attacks or heart-related deaths in postmenopausal women. The Raloxifene Use for the Heart (RUTH) trial is set to begin enrolling 10,000 women worldwide in May and June. Evista was approved in December 1997 for the prevention of osteoporosis in postmenopausal women. It was the first drug in the SERM class to win approval from the US Food and Drug Administration. According to a Lilly statement issued at that time, Evista ''is being studied for its selective ability to act like estrogen in some tissues but not in others.'' Reut13:38 04-21-98 (21 Apr 1998 13:37 EDT)