“Kylie Minogue's breast cancer drove sis Dannii to Botox - New Kerala” plus 4 more |
- Kylie Minogue's breast cancer drove sis Dannii to Botox - New Kerala
- Phase 3 Trial Shows Denosumab Delayed Skeletal Related Events in ... - Phramalive.com
- Hormone therapy tied to lung cancer deaths - San Francisco Chronicle
- Myrick speaks on health care - Digital Courier
- U.S. Rep.: Reform may usher in deadly delays - AZCentral.com
| Kylie Minogue's breast cancer drove sis Dannii to Botox - New Kerala Posted: 22 Sep 2009 07:43 AM PDT London, September 22 : Kylie Minogue's sister Dannii has revealed that after her sister was diagnosed with breast cancer, she became terribly depressed and got addicted to Botox.
'My sister was sick, then my best friend died soon after - I felt I'd been hit by a wave. I couldn't deal with the stress,' the Sun quoted Danni as saying Kylie was diagnosed with the disease in May 2005 but recovered. Danni said: 'I couldn't deal with having to look at my face. It was a personal thing of having to get through a lot of sadness. At first, it was something fun I tried, then it became a necessity.' However, the singer got rid of her addiction to the skin-tightening injections after she started dating Australian model Kris Smith. She said: 'I don't need Botox now and don't want it. Life is just so different now. I'm in such an incredible place.' Danni is also thinking of having babies with her lover. She said: 'I guess at my age I have to start thinking about babies at some time. But to be honest, I'm just enjoying being so wildly in love and being so happy. He is the one.' --ANI
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| Phase 3 Trial Shows Denosumab Delayed Skeletal Related Events in ... - Phramalive.com Posted: 22 Sep 2009 05:34 AM PDT
THOUSAND OAKS, Calif., Sept. 21 /PRNewswire-FirstCall/ -- Amgen (NASDAQ: AMGN) today announced detailed results from a Phase 3 trial evaluating denosumab administered subcutaneously versus Zometa (zoledronic acid) administered as an intravenous infusion in the treatment of bone metastases in 1,776 advanced cancer patients with solid tumors (not including breast and prostate cancer) or multiple myeloma. These results were presented today at the 2009 ECCO 15 - ESMO 34 European Multidisciplinary Congress in Berlin, Germany (Abstract Number: 20LBA). For the primary endpoint of this study, the median time to first on-study skeletal related event (SRE) (fracture, radiation to bone, surgery to bone, or spinal cord compression) was 20.6 months for those patients receiving denosumab and 16.3 months for those patients receiving Zometa (hazard ratio 0.84, 95 percent CI: 0.71-0.98), which is statistically significant for non-inferiority (p=0.0007). Although numerically greater, the delay in the time to first SRE associated with denosumab was not statistically superior compared to Zometa based upon the statistical testing strategy (adjusted p=0.06) (secondary endpoint). The time to first-and-subsequent SRE was also numerically greater but not statistically superior compared to Zometa (hazard ratio 0.90, 95 percent CI: 0.77-1.04, p=0.14) (secondary endpoint). "It is encouraging to see denosumab's efficacy in this broad cancer population. There is no need for renal monitoring or dose adjustments due to renal impairment," said David Henry, M.D., clinical professor of Medicine, Pennsylvania Hospital, Philadelphia, PA, United States of America. "Furthermore, the positive results of this study, combined with the convenience of a monthly subcutaneous injection and without the flu-like symptoms associated with Zometa administration, make this an exciting potential treatment option for advanced cancer patients." Bone metastases, the spread of tumors to the bone, are a serious concern for many advanced cancer patients. When cancer spreads to the bone, the growing cancer cells weaken and destroy the bone around the tumor. This damage can result in a number of serious bone complications, collectively called skeletal related events. Denosumab also delayed the median time to first on-study SRE or hypercalcemia of malignancy (HCM) compared to Zometa (hazard ratio 0.83, 95 percent CI: 0.71, 0.97; p=0.02). The median time to first on-study SRE or HCM was 19.0 months for denosumab and 14.4 months for Zometa. Bone destruction is a major cause of pain in approximately 70 percent of patients with metastatic disease. (1) In an exploratory analysis, patients on the denosumab arm reported worsening of pain later than those on the Zometa arm (57 days versus 36 days, respectively). Adverse events rates (96 percent denosumab, 96 percent Zometa) and serious adverse events (63 percent denosumab, 66 percent Zometa) were similar between groups and were consistent with what has previously been reported for these two agents. Rates of osteonecrosis of the jaw (ONJ) were balanced and infrequent in both treatment groups (10 patients receiving denosumab as compared with 11 patients receiving Zometa). Infectious adverse events were balanced between the two treatment arms, as was overall survival (hazard ratio 0.95, 95 percent CI: 0.83-1.08; p=0.43) and the time to cancer progression (hazard ratio 1.00, 95 percent CI: 0.89, 1.12; p=1.0). Detailed data from a second Phase 3, head-to-head trial evaluating denosumab versus Zometa will be presented Tuesday, Sept. 22, 2009 at 14:15 - 14:30 Central European Summer Time (CEST) in the Presidential Session of ECCO-ESMO (Abstract #2LBA; presentation embargoed until 12:15 CEST Sept. 22, 2009). In this study of 2,049 patients with advanced breast cancer, denosumab met all primary and secondary endpoints and demonstrated superior efficacy compared to Zometa in the treatment of bone metastases. Webcast Information Denosumab data presented at ECCO-ESMO today will be discussed by Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen at the UBS Global Life Sciences Conference in New York this morning at 8:30 a.m. Eastern Time (ET). Live audio of the presentation will be available over the Internet and can be accessed from Amgen's Web site at www.amgen.com, under Investors. An analyst/investor event will also be held from the Congress on September 24th, at 6:30 a.m. ET to discuss data presented at ECCO-ESMO. A webcast of the event can be found on Amgen's Web site at www.amgen.com, under Investors. The audio webcast will be archived and available for replay for at least 72 hours. Study Design This was an international, Phase 3, randomized, double-blind, active-comparator-controlled study comparing denosumab with Zometa in the treatment of bone metastases in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma. Patients enrolled in this event-driven study were randomized in a one-to-one ratio to receive either 120 mg of denosumab subcutaneously every four weeks (Q4W) or Zometa administered intravenously at a dose of 4 mg delivered as a single, 15-minute infusion every four weeks. In clinical trials thus far to test new medications for bone metastases, treatment success has been measured by whether the bone complications, or SREs, caused by the tumor are reduced or delayed. The primary and secondary endpoints of the denosumab bone metastases studies use a composite endpoint of four SREs - fracture, the need for radiation to bone, the need for bone surgery, and spinal cord compression - to measure the effectiveness of denosumab versus Zometa. The primary endpoint was to evaluate if denosumab is non-inferior to Zometa with respect to the first on-study SRE in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma and bone metastases. Secondary endpoints were to evaluate if denosumab is superior to Zometa with respect to the first on-study SRE, as well as first-and-subsequent on-study SREs, and to assess the safety and tolerability of denosumab compared with Zometa. About Denosumab and Amgen's Research in Bone Biology Denosumab is the first fully human monoclonal antibody in late stage clinical development that specifically targets RANK Ligand, the essential regulator of osteoclasts (the cells that break down bone). With more than 19,000 patients in trials across indications worldwide, the denosumab development program is the largest ever initiated by Amgen. This broad and deep development program demonstrates Amgen's commitment to researching and delivering pioneering medicines to patients with unmet medical needs. Amgen is studying denosumab in numerous tumor types across the spectrum of cancer-induced bone disease. Over 11,000 patients have been enrolled in the denosumab oncology clinical trials, testing the drug for the reduction of SREs in breast cancer patients, for the amelioration of treatment-induced bone loss in patients with breast or prostate cancers, for the prevention of SREs due to the spread of cancer to the bone in patients with multiple myeloma or those suffering from a variety of solid tumors, and for its potential to delay bone metastases in prostate cancer. Bone Metastases: Impact and Prevalence Bone metastases, cancer cells that separate from tumors and migrate to bone tissue where they settle and grow, occur in more than 1.5 million people worldwide.(2) With improvements in cancer care, including earlier diagnosis and new treatment options, leading to increases in survival rates(3), the number of patients developing metastatic disease secondary to a primary cancer is increasing. Bone metastases are a significant problem for patients with certain types of advanced cancer, with incidence rates of nearly 100 percent in myeloma patients and as high as 75 percent in solid tumor patients. With bone metastases the growing cancer cells weaken and destroy the bone around the tumor. The damage the tumor has caused to the bone can result in a number of serious complications, collectively called SREs. These include fracture of a bone, the need for radiation to bone, the need for bone surgery, or spinal cord compression. All are serious complications for advanced cancer patients. Regardless of the type of underlying cancer, the process by which cancers invade and destroy bones is fundamentally the same. At the center of this destructive process is a protein RANK Ligand that is stimulated by the presence of cancer in the bone. The economic burden of U.S. patients with bone metastases is significant and was estimated to be $12.6 billion last year.(4) Patients with bone metastases who experience an SRE incur significantly higher medical costs compared with those who do not experience an SRE.(5) About Amgen Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com. Forward-Looking Statements This news release contains forward-looking statements that are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen's most recent annual report on Form 10-K and most recent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen's most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of Sept. 21, 2009 and expressly disclaims any duty to update information contained in this news release. No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and products liability claims. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development. In addition, sales of our products are affected by the reimbursement policies imposed by third-party payors, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and health care cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government and others' regulations and reimbursement policies may affect the development, usage and pricing of our products. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. We believe that some of our newer products, product candidates or new indications for existing products, may face competition when and as they are approved and marketed. Our products may compete against products that have lower prices, established reimbursement, superior performance, are easier to administer, or that are otherwise competitive with our products. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors and there can be no guarantee of our ability to obtain or maintain patent protection for our products or product candidates. We cannot guarantee that we will be able to produce commercially successful products or maintain the commercial success of our existing products. Our stock price may be affected by actual or perceived market opportunity, competitive position, and success or failure of our products or product candidates. Further, the discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. The scientific information discussed in this news release relating to new indications for our products is preliminary and investigative and is not part of the labeling approved by the U.S. Food and Drug Administration (FDA) for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. Only the FDA can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this news release. ZOMETA is a registered trademark of Novartis Oncology. *Editors Note: The FDA has provisionally approved the trade name Prolia(TM) for the proposed indications of treatment and prevention of osteoporosis in postmenopausal women, and treatment and prevention of bone loss in patients undergoing hormone ablation for non-metastatic prostate or breast cancer, for which denosumab is administered twice yearly subcutaneously at a 60 mg dose. The Prolia(TM) trade name is only for these indications and may not apply for other indications of denosumab. CONTACT: Amgen, Thousand Oaks Sabeena Ahmad: +41 (0) 41 369 25 30 (media Europe/Australia) Lisa Rooney: +1 (805) 447-6437 (media U.S.) Arvind Sood: +1 (805) 447-1060 (investors) (Logo: http://www.newscom.com/cgi-bin/prnh/20081015/AMGENLOGO)
metastatic cancer. N Engl J Med. 1994: 330:592-596. 2. Capanna R, Coia LR, Coleman R. et al. eds. Textbook of Bone Metastases. Hoboken, NJ: Edition: John Wiley and Sons; 2005:105. 3. Mundy GR. Metastasis to bone: causes, consequences and therapeutic opportunities. Nat Rev Cancer. 2002 Aug;2(8):584-93. 4. Schulman K and Kohles J. Cancer. 2007;109:2334-2342 5. GVD/Barber ISPOR 2008 Poster; Schulman 2007; Delea et al. 2006 Photo: http://www.newscom.com/cgi-bin/prnh/20081015/AMGENLOGO Source: Amgen CONTACT: media Europe/Australia, Sabeena Ahmad, +41 (0) 41 369 25 30, or Web Site: http://www.amgen.com/  This posting includes an audio/video/photo media file: Download Now |
| Hormone therapy tied to lung cancer deaths - San Francisco Chronicle Posted: 18 Sep 2009 04:59 PM PDT The findings "seriously question whether hormone-replacement therapy has any role in medicine today," wrote Dr. Apar Kishor Ganti of the University of Nebraska Medical Center in an editorial accompanying the online publication of the report in the medical journal Lancet. The findings come from the Women's Health Initiative, a large study originally begun in 1991 to demonstrate, in part, that administration of a combination of estrogen and progestin could relieve debilitating symptoms of menopause and reduce the risk of heart attack and stroke. The hormone replacement arm, which enrolled more than 16,000 women, was halted prematurely after about 51/2 years when it was observed that the risks far outweighed any potential benefits. Treatment with estrogen has a deleterious effect on breast cancer patients because the hormone binds to estrogen receptors on tumor tissue, accelerating its growth. Recent laboratory studies have shown that lung tissue also has estrogen receptors and that the accelerated growth is even more dramatic in lung tumor cells, according to Dr. Richard Pietras of UCLA's Jonsson Comprehensive Cancer Center. The incidence of lung cancer in women has been growing and more women now die from it than from breast, ovarian and colon cancers combined. About 99,000 women are diagnosed with lung cancer each year, and 71,000 die. The first results from the Women's Health Initiative suggested that the hormones might have an effect on lung cancer. To further explore a link, Dr. Rowan Chlebowski of the Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center and his colleagues studied the women in the Women's Health Initiative for an additional 21/2 years. At the end of the eight-year period, they found that 109 women who received the estrogen and progestin treatments had been diagnosed with lung cancer, compared with 85 in the group that received a placebo - a modest 23 percent increase in incidence. The difference was more dramatic when they considered deaths. In the group receiving hormone therapy, 73 women died, compared with 40 in the placebo group, a 71 percent increase. The increase in lung cancer deaths accounted for half of the overall increase in deaths in the women receiving hormone therapy, Chlebowski said. The findings suggest that the hormones do not themselves cause lung cancer, but that they accelerate the growth of existing tumors, making them more aggressive and more likely to metastasize, Chlebowski said.
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| Myrick speaks on health care - Digital Courier Posted: 19 Sep 2009 05:19 PM PDT WASHINGTON — A GOP congresswoman grateful for quick detection of her breast cancer says Democratic health overhaul plans could mean life-threatening delays in treatment. Rep. Sue Myrick of North Carolina said in her party's weekly radio and Internet address that her diagnosis "took six doctors, three mammograms and one ultrasound before they finally they found my cancer. This process took only a few weeks." "Under the government-run health care system they have in Canada and the United Kingdom, I wouldn't have had the opportunity to get those tests so quickly," she said. "One international study found that three times as many citizens in those countries wait longer than a month to see a specialist. When it comes to life-threatening diseases like cancer, delay could mean death." Democrats are looking for competition to private insurance companies to help drive prices down: a government-run insurance option, a trigger to add that option later; or nonprofit insurance cooperatives, designed to compete with private industry and give consumers more choices. "These so-called health care reform bills have different names: a public option, a co-op, a trigger," Myrick said. "Make no mistake, these are all gateways to government-run health care." She said that the proposals mean higher taxes for small business owners "at a time when unemployment is nearing 10 percent and analysts are predicting that any kind of recovery will be a jobless one." Myrick ran an advertising and public relations business and was mayor of Charlotte, N.C., before coming to Congress in 1995. "I can tell you from experience that this is the worst possible time to be imposing new, job-killing taxes. In fact, the nation's largest small business association found the health care tax increases being proposed would lead to the elimination of more than 1.6 million jobs." She said seniors should expect massive cuts to Medicare. "Doing this now, without implementing significant reforms to make the program more efficient, would leave seniors susceptible to the rationing of care," she said. Obama has said eliminating "waste and abuse" in the Medicare and Medicaid programs will help the government find money to cover most of the Americans now without insurance. Myrick said the overhaul "comes at a price tag of roughly $1 trillion in the midst of a year in which the government continues to set new records for red ink." Obama has set a 10-year spending target of $900 billion for lawmakers considering various proposals.
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| U.S. Rep.: Reform may usher in deadly delays - AZCentral.com Posted: 20 Sep 2009 12:50 AM PDT WASHINGTON - A GOP congresswoman grateful for quick detection of her breast cancer says Democratic health overhaul plans could mean life-threatening delays in treatment. Rep. Sue Myrick of North Carolina said in her party's weekly radio and Internet address that her diagnosis "took six doctors, three mammograms and one ultrasound before they finally they found my cancer. This process took only a few weeks." "Under the government-run health-care system they have in Canada and the United Kingdom, I wouldn't have had the opportunity to get those tests so quickly," she said. "One international study found that three times as many citizens in those countries wait longer than a month to see a specialist. When it comes to life-threatening diseases like cancer, delay could mean death." Democrats are looking for competition to private insurance companies to help drive prices down: a government-run insurance option, a trigger to add that option later; or non-profit insurance cooperatives, designed to compete with private industry and give consumers more choices. "These so-called health care reform bills have different names: a public option, a co-op, a trigger," Myrick said. "Make no mistake, these are all gateways to government-run health care." She said that the proposals mean higher taxes for small-business owners.  This posting includes an audio/video/photo media file: Download Now |
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