Archive for Mayo, 2009
Mayo 23, 2009
Filed Under (pharma industry) by admin
Bayer HealthCare Pharmaceuticals, Inc. announced that new data on Bayers novel anticancer development candidate BAY 734506 (DASTInhibitor) will be presented at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Orlando, Florida, May 29 June 2. “Bayer is committed to expanding our oncology franchise, and the oral multikinase inhibitor BAY 734506 is one of the promising compounds in the companys pipeline,” said Kemal Malik, MD, member of the Board of Management and Chief Medical Officer and Head of Global Development at Bayer HealthCare. “We look forward to determining the role of BAY 734506, along with other compounds in our franchise, in creating potential treatment options for patients afflicted with various cancers.” The BAY 734506 data being presented are BAY 734506 Phase I study of BAY 734506, an inhibitor of oncogenic and angiogenic kinases, in patients with advanced refractory colorectal carcinoma Dirk Strumberg, MD, Department of Hematology and Medical Oncology, Marienhospital Herne, University Medical School of Bochum, Germany Abstract 3560, Poster, Saturday, May 30, 2009, 8001100 a.m., Level 2, West Hall C Phase II study of BAY 734506, a multikinase inhibitor, in previously untreated patients with metastatic or unresectable renal cell cancer Professor Tim Eisen, PhD, Addenbrookes Hospital and the University of Cambridge, UK Abstract 5033, Poster Discussion, Friday, May 29, 2009, 200600 p.m., Level 2, W230A About BAY 734506 (DASTInhibitor) BAY 734506 is a novel oral multikinase inhibitor with a kinase inhibition profile targeting angiogenic, stromal and oncogenic receptor tyrosine kinases (TK). BAY 734506 has been shown to inhibit tumor growth in preclinical models by hitting targets along a spectrum of angiogenic pathways, including VEGFR and TIE2. BAY 734506 has also been shown to prevent the proliferation of tumor cell lines while promoting apoptosis (cell death) by directly targeting several oncogenic TK receptors. The mechanism may offer promise to treat a broad spectrum of tumors. About Bayer HealthCare Pharmaceuticals Inc. Bayer HealthCare Pharmaceuticals Inc. is the U.S.based pharmaceuticals unit of Bayer HealthCare LLC, a subsidiary of Bayer Corporation. One of the worlds leading, innovative companies in the healthcare and medical products industry, Bayer HealthCare combines the global activities of the Animal Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the U.S., Bayer HealthCare Pharmaceuticals comprises the following business units Diagnostic Imaging, General Medicine, Specialty Medicine and Womens Healthcare. The companys aim is to provide products that will improve human health worldwide by diagnosing, preventing and treating diseases. ForwardLooking Statements This release may contain forwardlooking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here.
Mayo 22, 2009
Filed Under (womens health) by admin
The Louisiana House on Tuesday voted 8213 to approve legislation (HB 517) that would allow some health professionals to refuse to provide certain medical services that they object to on religious or moral grounds, the New Orleans TimesPicayune reports. Reprinted with kind permission from nationalpartnership.org. You can view the entire Daily Womens Health Policy Report, search the archives, or sign up for email delivery here. The Daily Womens Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company. © 2009 The Advisory Board Company. All rights reserved.
Mayo 21, 2009
Filed Under (diabetes) by admin
Surgical Review Corporation (SRC), an independent, nonprofit organization that advances the efficacy, efficiency and safety of bariatric and metabolic surgery, announced that the number of registered patients entered into its Bariatric Outcomes Longitudinal Database™ (BOLD™) has now surpassed 120,000. BOLD, the worlds largest dedicated repository of bariatric surgery patient information, provides the mechanism for identifying risk factors and quality indicators, developing risk stratification guidelines, and enabling continuous quality improvement for bariatric surgery. All participants in the Bariatric Surgery Center of Excellence® (BSCOE®) program, which SRC administers on behalf of the American Society for Metabolic and Bariatric Surgery, are required to enter information into BOLD for every bariatric surgical procedure and patient encounter, including complications and comorbidities. “Nearly 900 surgeons and more than 500 hospitals are now entering data into BOLD,” said Neil Hutcher, M.D., FACS, Chairman of the SRC Board of Directors and a practicing BSCOE bariatric surgeon in Richmond, Va. “Im also pleased to announce that 100 percent of BSCOE designees are BOLD users. A remarkable accomplishment when compared to a recent study reporting that only 7.6 percent of U.S. hospitals use an electronic health record. This level of participation demonstrates that bariatric surgeons are truly dedicated to determining the best care for their patients.” In June, SRC will provide aggregate benchmark data to BOLD users so that they can compare their own data to the entire research dataset. The organization also plans to publish national aggregate data reports, establishing a basis for best practices. “BOLD provides a unique platform for evidencebased medicine,” said Deborah Winegar, Ph.D., Director of Research at SRC. “The large volume of data it contains supports indepth analysis of the value and efficacy of different surgical procedures. BOLD will shape the future of bariatric surgery and guide the care of those suffering with obesity and diabetes.” Source
Mayo 20, 2009
Filed Under (dermatology) by admin
Blacks and others with darker skin might be at greater risk for tobacco addiction than whites and those with lighter skin because the greater the amount of melanin, the coloring pigment in skin, the more nicotine appears to be stored, according to preliminary findings published in the journal Pharmacology, Biochemistry and Behavior, the New York Times reports. For the study, lead researcher Gary King, a professor of biobehavioral health at Pennsylvania State University, looked at 150 black smokers and measured their levels of melanin and cotinine, a byproduct of nicotine. They also surveyed the participants to determine the level of their smoking habit. Reprinted with kind permission from kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation. © 2009 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
Mayo 20, 2009
Filed Under (dermatology) by admin
Skin from a factory this has long been the dream of pharmacologists, chemists and doctors. Research has an urgent need for large quantities of skin models, which can be used to determine if products such as creams and soaps, cleaning agents, medicines and adhesive bandages are compatible with skin, or if they instead will lead to irritation or allergic reactions for the consumer. Such test results are seen as more meaningful than those from animal experiments, and can even make such experiments largely superfluous. But artificial skin is rare. “The production is complex and involves a great deal of manual work. At this time, even the markets established international companies cannot produce more than 2,000 tiny skinpieces a month. With annual requirements of more than 6.5 million units in the EU area alone, however, the industrial demand far exceeds all currently available production capacities,” reports Jörg Saxler. Together with Prof. Heike Mertsching, he is coordinating the “Automated Tissue Engineering on Demand” project within the FraunhoferGesellschaft. Tissue engineering is still in its infancy. “Until now, the offer was limited predominantly to singlelayer skin models that consist of a single cell type,” explains Mertsching, who heads the Cell Systems Department at the Fraunhofer Institute for Interfacial Engineering and Biotechnology IGB. “Thanks to developments at our institute, the project team has access to a patentprotected skin model that consists of two layers with different cell types. This gives us an almost perfect copy of human skin, and one that provides more information than any system currently available on the market.” An interdisciplinary team of Fraunhofer researchers is currently developing the first fully automatic production system for twolayer skin models. “Our engineers and biologists are the only ones who have succeeded in fully automating the entire process chain for manufacturing twolayer skin models,” explains Saxler, who is from the Fraunhofer Institute for Production Technology IPT where he is responsible for technology management and heads the “Life Science Engineering” business unit. In a multistage process, first small pieces of skin are sterilized. Then they are cut into small pieces, modified with specific enzymes, and isolated into two cell fractions, which are then propagated separately on cell culture surfaces. The next step in the process combines the two cell types into a twolayer model, with collagen added to the cells that are to form the flexible lower layer, or dermis. This gives the tissue natural elasticity. In a humid incubator kept at body temperature, it takes the cell fractions less than three weeks to grow together and form a finished skin model with a diameter of roughly one centimeter. The technique has already proven its use in practice, but until now it has been too expensive and complicated for mass production. Mertsching explains, “The production is associated with a great deal of manual work, and this reduces the methods efficiency.” The project team, in which engineers, scientists and technicians from four Fraunhofer institutes are cooperating, is currently working at full speed to automate the work steps. The researchers at the IGB and the Fraunhofer Institute for Cell Therapy and Immunology IZI are handling the development of the biological fundamentals and validation of the machine and its submodules. Experts from the Fraunhofer Institute for Manufacturing and Automation IPA and the Fraunhofer Institute for Production Technology IPT are taking care of prototype development, automation and integration of the machine into a complete functional system. “At the beginning, our greatest challenge was to overcome existing barriers, because each discipline had its own very different approach,” Saxler remembers. “Meanwhile, the four institutes are working together very smoothly everyone knows that progress is impossible without input from the others.” After working together for one year, the project team has already initiated eight patent procedures. At a collective FraunhoferGesellschaft booth at the 2009 BIO in Atlanta, the researchers are presenting a computer model of the overall system, along with the three fundamental submodules. The first module prepares the tissue samples and isolates the two cell types; the second proliferates them. The finished skin models are built up and cultivated in the third, and then packed by a robot. The researchers still have a lot of meticulous work ahead before the machine will be finished. The difference between success and failure often depends on details, such as the quality of the skin pieces, processing times of enzymes, and liquid viscosities. Furthermore, the cell cultures must be monitored throughout the entire manufacturing process in order to provide optimal process control and to allow timely detection of any contamination with fungi or bacteria. The skin factory is expected to be finished in two years. “Our goal is a monthly production of 5,000 skin models with perfect quality, and a unit price under 34 euros. These are levels that are attractive for industry,” Saxler continues. But chemical, cosmetic, pharmaceutical, and medical technology companies who have to test the reaction of skin to their products are not the only ones interested in Automated Tissue Engineering. In transplantation medicine, surgeons require healthy tissue in order to replace destroyed skin sections when burn injuries cover large portions of the body. The twolayer models that the new machine is intended to produce are not yet suitable for this purpose, however. “They dont have a blood supply, and are consequently rejected by the body after some time,” Saxler explains. But IGB researchers are already working on a fullskin model that will even include blood vessels. Once the research has been completed, fully automatic production of the transplants should also be possible. “We have designed the production system in such a way that it satisfies the high standards for good manufacturing practices (GMP) for the manufacture of products used in medicine,” Mertsching explains. “And so they are also suitable for producing artificial skin for transplants.” This release is available in German. Source
Mayo 19, 2009
Filed Under (womens health) by admin
Seventysix percent of U.S. residents believe that abortion should be legal, a finding in keeping with public opinion over the past three decades, according to a Gallup poll released on Saturday, the AP/Boston Globe reports (AP/Boston Globe, 5/16). However, 51% of respondents identified themselves as “prolife,” while 42% said they are “prochoice” (Gallup poll, 5/16). The finding marks the first time since Gallup began asking about abortion rights in 1995 that a majority of respondents said they consider themselves “prolife” (Nadeau, Boston Herald, 5/16). Last years poll showed that 50% of respondents consider themselves “prochoice,” compared with 44% who said they are “prolife” (Abcarian, Los Angeles Times, 5/16). Reprinted with kind permission from nationalpartnership.org. You can view the entire Daily Womens Health Policy Report, search the archives, or sign up for email delivery here. The Daily Womens Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company. © 2009 The Advisory Board Company. All rights reserved.
Mayo 18, 2009
Filed Under (prostate) by admin
Fox Chase Cancer Center researchers have identified a genetic marker that is associated with an earlier onset of prostate cancer in Caucasian men who have a family history of prostate cancer. If the data are confirmed, the marker may help clinicians personalize prostate cancer screening. Veda Giri, M.D., a medical oncologist and director of the Prostate Cancer Risk Assessment Program at Fox Chase, presented the data at the annual meeting of the American Society of Clinical Oncology on May 30. “Genetic testing for prostate cancer is not yet clinically well characterized as it is for breast, ovarian cancer and colon cancer,” Giri says. “Markers such as this one are useful because they may help clinicians distinguish between men who are at risk for earlier onset of disease where intensive screening approaches can be discussed. Men who do not carry genetic markers of risk may not need such screening measures.” More than half of all prostate tumors carry a fusion gene called, TMPRSS2ERG, which may have a role in prostate cancer formation. Recently, scientists reported that a single nucleotide polymorphism, called the Met160Val SNP (also referred to as rs12329760), is associated with the gene fusion. Specifically, prostate cancer patients who carry the T allele of Met160Val are more likely to have a prostate tumor with the gene fusion than patients who have the C allele. To find out if the T allele is clinically relevant in men who are at high risk of developing prostate cancer but do not yet have the disease, Giri and colleagues genotyped 631 men enrolled in the Prostate Cancer Risk Assessment Program at Fox Chase. Overall, while there were differences in the distribution of the alleles by race, the risk allele did not have a major contribution to disease in 400 African American men or in 231 Caucasian men with a family history of prostate cancer. They then evaluated this marker in 183 Caucasian men who have a family history of prostate cancer undergoing followup in the Prostate Cancer Risk Assessment Program. They found that the high risk allele was associated with a 2.5fold increased risk of developing prostate cancer, relative to the low risk allele. Additionally, more men carrying the high risk allele developed prostate cancer earlier than men not carrying the risk allele. “We need longer followup to know the precise time frame for cancer development, but we have learned some information on the difference in time to diagnosis from this study,” Giri says. According to Giri, a similar association between the T allele and disease may exist in African American men with a family history of prostate cancer, however, there were not enough of these men in the study to test the possibility. “This was a pilot study,” Giri says. “We are expanding the study to see if the association holds up in a larger Caucasian patient population. We are also planning collaborations with investigators at other institutions to test if this marker would be informative in African American men with a family history.” Abstract #5000 Source
Mayo 17, 2009
Filed Under (pharma industry) by admin
Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA CTIC) announced that data from CTIs pivotal phase III EXTEND (PIX301) trial of pixantrone in patients with advanced, relapsed aggressive nonHodgkins lymphoma (NHL) will be presented at the 2009 American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held from May 29 to June 2, 2009 in Orlando, Florida. Ruth Pettengell, M.D. of St. Georges Hospital, University of London, an investigator on the study, is scheduled to present the data on Monday, June 1, 2009 during the Lymphoma and Plasma Cell Disorders session that will be held from 200 PM600 PM Eastern Time. The presentation, abstract #8523, is titled, “Randomized Phase III trial of pixantrone compared with other chemotherapeutic agents for thirdline singleagent treatment of relapsed aggressive nonHodgkins lymphoma.” CTI expects to complete the submission of a New Drug Application (”NDA”) for pixantrone this quarter and will request priority review which if granted could lead to an approval decision from the U.S. Food and Drug Administration (”FDA”) during the fourth quarter of 2009. About Pixantrone Pixantrone (BBR 2778), is a novel major groove binder with an azaanthracenedione molecular structure that differentiates it from the anthracyclines and other related chemotherapy agents. Anthracyclines are the cornerstone therapeutic for the treatment of lymphoma, leukemia, and breast cancer. Although they are sufficiently effective to be used as firstline (initial) treatment, they cause cumulative heart damage that may result in congestive heart failure many years later. As a result, there is a lifetime limit of anthracycline doses and most patients who previously have been treated with an anthracycline are not able to receive further anthracycline treatment if their disease returns. Pixantrone has been designed to reduce the potential for these severe cardiotoxicities without sacrificing anticancer activity. It also can be administered through a peripheral vein rather than a central implanted catheter as required for other drugs in this class. About Cell Therapeutics, Inc. Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. About Pixantrone Pixantrone (BBR 2778), is a novel major groove binder with an azaanthracenedione molecular structure that differentiates it from the anthracyclines and other related chemotherapy agents. Anthracyclines are the cornerstone therapeutic for the treatment of lymphoma, leukemia, and breast cancer. Although they are sufficiently effective to be used as firstline (initial) treatment, they cause cumulative heart damage that may result in congestive heart failure many years later. As a result, there is a lifetime limit of anthracycline doses and most patients who previously have been treated with an anthracycline are not able to receive further anthracycline treatment if their disease returns. Pixantrone has been designed to reduce the potential for these severe cardiotoxicities without sacrificing anticancer activity. It also can be administered through a peripheral vein rather than a central implanted catheter as required for other drugs in this class. About Cell Therapeutics, Inc. Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. This press release includes forwardlooking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results. Specifically, the risks and uncertainties that could affect the development of pixantrone include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general and with pixantrone in particular including, without limitation, the potential failure of pixantrone to prove safe and effective for treatment of relapsed aggressive NHL as determined by the FDA, the possibility that the New Drug Application submission will not be completed in the second quarter of 2009, that priority review will not be granted by the FDA and that a decision by the FDA is not rendered in late 2009, the companys ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, costs of developing, producing and selling pixantrone, and the risk factors listed or described from time to time in the Companys filings with the Securities and Exchange Commission including, without limitation, the Companys most recent filings on Forms 10K, 8K, and 10Q. Except as may be required by law, CTI does not intend to update or alter its forwardlooking statements whether as a result of new information, future events, or otherwise. Source Cell Therapeutics, Inc
Mayo 17, 2009
Filed Under (urology nephrology) by admin
Researchers are zeroing in on the genetic abnormalities predisposing to vesicoureteric reflux (VUR), one of the most common causes of urinary tract infections and kidney failure in children, reports a study in an upcoming issue of the Journal of the American Society of Nephrology (JASN). “In this study, we accomplished a very critical step towards the identification of the VUR gene,” says Ali G. Gharavi, MD (Columbia University, New York). Led by Patricia L. Weng, MD (Mount Sinai School of Medicine), and Simone SannCherchi, MD (Columbia University), the researchers, including Gharavi, performed genetic studies in 16 large families affected by VUR. “In VUR, a faulty valve in the bladder allows urine to flow back, or reflux, up to the kidneys,” Gharavi explains. If VUR persists, it can lead to repeated urinary tract infections and kidney failure. It affects about one percent of children and runs in families. A method called linkage analysis was used to pinpoint the location of the abnormal genes associated with VUR. “We narrowed down the location of the VUR susceptibility gene to a region on chromosome 12 that is less than one percent of the entire genome,” says Gharavi. In contrast to previous studies, the VUR susceptibility gene appeared to be inherited in autosomal recessive fashion affected children inherit one copy of the faulty gene from each parent. According to Gharavi, “This means that there are many different inherited forms of VUR, some with dominant and some with recessive inheritance.” The next step will be conducting studies to identify the exact gene predisposing to VUR. “We plan to study more families and other patients with VUR so that we can better understand how the kidney and urinary tract develop and then create better diagnostic tests and treatments,” Gharavi adds. Although the study does not identify the gene causing VUR, it represents the initial, critical step towards achieving that goal. The study was limited to a specific group of Caucasian patients; more research will be needed to determine whether the results apply to other populations and ethnicities. The authors reported no financial disclosures. The research was supported by the National Institute of Diabetes and Digestive and Kidney Diseases, the National Kidney Foundation, and the Telethon Institute. Founded in 1966, the American Society of Nephrology (ASN) is the worlds largest professional society devoted to the study of kidney disease. Comprised of 11,000 physicians and scientists, ASN continues to promote expert patient care, to advance medical research, and to educate the renal community. ASN also informs policymakers about issues of importance to kidney doctors and their patients. ASN funds research, and through its worldrenowned meetings and firstclass publications, disseminates information and educational tools that empower physicians. Source American Society of Nephrology (ASN)
Mayo 16, 2009
Filed Under (prostate) by admin
Tiny bubbles of fat in urine hold molecules that could predict whether prostate cancer is aggressive, according to research published in the British Journal of Cancer. Molecules called RNA that are carried directly from the tumour out of the body in fatty capsules called exosomes can be used to figure out which genes are turned on and off in an individuals cancer. Exosomes are found in urine from people with and without cancer, but seem to be excreted in large quantities by some cancer cells. For the first time, scientists have discovered that tumourderived genetic information inside urinary exosomes can be used for tumour detection and biomarker discovery. This information could help doctors decide which prostate cancers are aggressive and require rapid treatment. Many cases do not progress and can be left untreated. Invasive treatment can leave men with longterm side effects, including incontinence and impotence, so distinguishing between the aggressive and dormant tumours is one of the biggest challenges for researchers in the field. Up until now, researchers have used levels of proteins, like prostate specific antigen (PSA), produced by cancer cells to try to spot the aggressive tumours. This new approach analyses RNA which is involved in the production of proteins like PSA — to take a step further back and find out which genes have gone wrong inside the cancer. Different genes are switched on and off in aggressive and dormant prostate cancers. Dr Jonas Nilsson, lead author based at the VU University Medical Centre in Amsterdam, said “We hope that this innovative approach to studying prostate cancer will reveal new biomarkers for aggressive tumours. “Tumourderived RNA is preserved in these capsules and gives us an insight into the genetics of an individuals tumour.” Prostate cancer is the most common cancer in men in the UK, with around 34,000 new cases diagnosed each year. Around 10,000 men die from the disease each year in the UK. Dr Lesley Walker, director of cancer information at Cancer Research UK, said “This technique is a fresh view on an old problem and could really help scientists find that elusive biomarker. “Its still unclear what the best treatment approach is for early prostate cancer, so its important we find answers to this as soon as possible. “Distinguishing the aggressive tumours that must be treated from those that dont need treatment will go a long way towards resolving this issue.” Notes |
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