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Biotech / Medical : Ligand (LGND) Breakout! -- Ignore unavailable to you. Want to Upgrade?

To: John O'Neill who wrote (21067)	5/18/1998 6:13:00 PM
From: Henry Niman	Read Replies (1) \| Respond to of 32384

I think that tomorrows breast cancer combo treatment (Panretin and Tamoxifen) could generate some interest, especially if there is any efficacy data. If only safety data is presented, there may not be much excitement unless the news is tied into the chemoprevention studies.

To: John O'Neill who wrote (21067)	5/18/1998 8:10:00 PM
From: Henry Niman	Respond to of 32384

Here's what Reuter's had to say about Evista: Monday May 18 6:00 PM EDT Raloxifene cuts breast cancer risk LOS ANGELES (Reuters) -- The drug raloxifene (sold under the name Evista), prescribed to prevent osteoporosis in postmenopausal women, may also reduce their risk of breast cancer by almost 70%, according to preliminary results presented here at the American Society of Clinical Oncology (ASCO) annual meeting. Raloxifene is a selective estrogen receptor modulator (SERM), a class of estrogen-like drugs developed to maximize the health benefits of the female hormone for the heart and bone, but minimize the risk of cancer in the uterine lining and the breast. In a study of 7,705 postmenopausal women with osteoporosis, 0.21% of women taking raloxifene (either 60 milligrams or 120 milligrams) developed breast cancer during a 30-month period compared with 0.82% of women taking a placebo ("dummy pill"). Overall, this represents nearly a 70% reduction in breast cancer incidence , according to the report. In the study there was no increase in the risk of endometrial cancer, or cancer of the uterine lining, among women taking the drug, said Dr. Steven R. Cummings of the University of California at San Francisco who presented the 2-year findings from the study. The women receiving raloxifene actually had a 50% lower rate of endometrial cancer, in contrast to tamoxifen, which increases endometrial cancer risk 2- or 3-fold. However, Cummings noted that the number of women who developed endometrial cancer was too small to achieve statistical significance. Unpublished data suggest that raloxifene raises the risk of blood clots by about the same amount as tamoxifen or hormone replacement therapy. "For invasive breast cancer," Cummings said, "we've seen 22 cases in the placebo group, which is smaller (in number of patients enrolled), and 13 cases in the raloxifene group, which is twice as large, and that means we are seeing a 70% reduction in the risk of invasive breast cancer in this study." Osteoporosis patients in the study had a lower rate of breast cancer overall than the general population. The researchers also note that the patients in their study differ from the high-risk women included in a recent study that found tamoxifen may prevent breast cancer in women who are breast cancer-free but still at high risk for the disease. "I think that the physician needs to take the information about the benefits and the risks and sit it down in front of the patient and help her make the decision," Cummings said. "I'm not going to tell you that raloxifene should be chosen above tamoxifen in every case." The raloxifene study will continue for another 4 or 5 years. "This is a very exciting beginning. It means that for the first 2 or 3 years there's a reduction. What will happen after 5 years is something that we need to continue to study," Cummings said. Meanwhile, researchers with the National Surgical Breast and Bowel Project say that this fall they are planning to begin enrolling up to 22,000 women at high risk for breast cancer in a trial that will directly compare tamoxifen with raloxifene. The potential benefits of raloxifene in relation to preventing breast cancer were leaked in newspaper reports last month. As reported at the time by Reuters Health, the drug's manufacturer elected to wait until the ASCO meeting to make public the details of clinical studies on the drug's effect in reducing breast cancer risk. In a company statement released Monday, Dr. August M. Watanabe, president of Lilly Research Laboratories, said, "We are committed to conducting additional research -- including long-term breast cancer prevention trials and cardiovascular trials -- that will tell us conclusively if Evista can provide multiple, preventive benefits for postmenopausal women."

To: John O'Neill who wrote (21067)	5/19/1998 6:01:00 AM
From: Henry Niman	Read Replies (1) \| Respond to of 32384

Here's more on SERMs: Monday May 18 11:29 PM EDT Two drugs may prevent breast cancer By Mark Egan LOS ANGELES (Reuters) - Women who have a high risk of breast cancer may have two drugs to choose from to prevent the disease -- one a cancer drug and one a drug originally designed for osteoporosis, researchers said Monday. They said both tamoxifen and raloxifene work to prevent breast cancer in certain woman. The news about raloxifene leaked out ahead of the annual meeting of the American Society of Clinical Oncology, but this was the first presentation of the details. Researchers said they were planning another trial that will pit the two drugs against each other to determine which of the two is more effective in preventing breast cancer. Dr. Steven Cummings of the University of California San Francisco said the osteoporosis drug raloxifene reduced the risk of developing breast cancer by 68 percent in post-menopausal women with osteoporosis. The trial of raloxifene, sold under the name Evista for treating osteoporosis by Eli Lilly & Co., began with the aim of determining the rate of fractures among women with osteoporosis and produced the breast cancer data as a bonus benefit. The study of almost 8,000 women found that raloxifene reduced the incidence of breast cancer in post-menopausal women by as much as 70 percent. Results indicated the drug did not increase the incidence of endometrial, or uterine, cancer. "These results for 33 months are very good news for women who are concerned about breast cancer and osteoporosis," Cummings told reporters. "Our trial is continuing so we can learn how well Evista prevents breast cancer over the longer term." Dr. Donald Wickerham of the National Surgical Adjuvant Breast and Bowel Project at Four Allegheny Center in Pittsburgh and colleagues did a separate study on tamoxifen. They found tamoxifen reduced the risk of breast cancer in 45 percent of women at high risk of the disease. "(This data) represents the first step in making the hope of breast cancer prevention a reality," Wickerham said. Wickerham said the comparison trial of the two drugs would begin this fall in post-menopausal women at high risk of breast cancer. Breast cancer is the most prevalent form of cancer in women, with about 180,000 cases diagnosed each year in the United States. It is expected that 43,500 women will die from the disease this year in the United States. Tamoxifen is marketed as a cancer drug under the name Nolvadex by Zeneca Group Plc. The two trials were not easily comparable given their different patients, hence the need for a comparison study. The tamoxifen trial followed 13,388 healthy women whose risk of contracting cancer was about five times greater than the average woman. High risk was determined by family history, age, pregnancy history, age at time of menstruation and other factors. The study found a small risk of some major complications. Patients taking tamoxifen increased their risk of developing endometrial cancer, cancer of the lining of the uterus. Of those who took tamoxifen in the trial, 33 developed endometrial cancer as compared to 14 in the placebo group. The risk of blood clots was also higher. Women under 50 had no excess risk of side effects, the report said. It was not a great surprise to doctors that raloxifene can work an an anti-cancer drug. Both tamoxifen and raloxifene are drugs called selective estrogen receptor modulators, which block the negative actions of estrogen in some tissues such as the breast and mimic estrogen's benefits in other tissues such as bones. In other cancer news, researchers said too many women with early stage breast cancer have their breasts removed even though many could be treated without having a mastectomy. A study of almost 18,000 women found that fewer than half, 44 percent, were treated in a way that would save their breasts -- despite guidelines from the National Cancer Institute stating that 75 percent of women with early stage breast cancer do not need mastectomies. Results of the study, which tracked the treatment of breast cancer patients in more than 800 U.S. hospitals in 1994, were presented by Dr. Monica Morrow of Northwestern University Medical School in Chicago. "If a woman is told she needs removal she should ask why," Morrow told reporters. "By seeking a second opinion ... we will see more decreases (in the number of mastectomies performed) over time." The study, sponsored by the American College of Surgeons and the American College of Radiology, found that women over 60 were less likely to receive breastbone therapy despite the fact that age is not supposed to be a factor in deciding whether to perform a mastectomy. The likelihood of a woman undergoing a mastectomy increased by 11 percent for each decade older she was, the study found. Breastbone therapy involves the removal of the tumor in the breast, called a lumpectomy, followed by radiation therapy. The NCI guidelines state that age, prognosis and tumor type should not be used to choose mastectomy over breast conserving therapy in early stage breast cancer. Breast cancer is deemed early stage in the period before the cancer becomes metastatic -- when it spreads to other sites in the body. The only factors that should be used in choosing mastectomy are large tumor size, small breast size, small breast size in comparison to tumor size, early pregnancy and multiple tumors in various sites of the breast, the NCI guidelines state. Morrow said patients without private medical insurance were more likely to have a breast removed that those with private insurance. Patients in the eastern and western sections of the United States were more likely to receive breast conservation therapy than those elsewhere in the country. In the East 58 percent of women were given breast conserving therapy, compared to 48 percent on the West Coast and just 33 percent in the South. The study also found that almost one quarter of women who underwent breast conservation therapy did not receive the needed radiation therapy -- because doctors failed to tell them about it and refer them for it. Morrow said the low rates of breast conservation therapy were a result of a poor understanding among doctors of the National Cancer Institute guidelines. Breast cancer is the most common form of cancer in women, with about 180,000 cases diagnosed each year in the United States and 43,500 deaths from it expected this year. About half of all cancer patients do not survive. Around 1.2 million cases of cancer are diagnosed annually in the United States and about 565,000 Americans are expected to die of the various forms of the disease in 1998.