Seattle Genetics, Inc. (Nasdaq: SGEN) announced that it has initiated a phase I clinical trial of SGN-75 for metastatic renal cell carcinoma and relapsed and refractory non-Hodgkin lymphoma. SGN-75 is an antibody-drug conjugate (ADC) targeting CD70 that utilizes the company’s proprietary technology.

“Our compelling preclinical data demonstrate that SGN-75 possesses potent antitumor activity in models of both CD70-positive renal cell carcinoma and hematologic malignancies,” said Clay B. Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. “CD70 is expressed on a variety of solid tumors, including renal cell carcinoma, pancreatic, ovarian and lung cancers and glioblastoma as well as multiple myeloma and several types of lymphoma. This broad expression profile provides substantial and diverse therapeutic opportunities to address unmet needs for patients with these malignancies.”

The single-agent phase I study is designed to enroll up to 80 patients at multiple centers in the United States. The trial will evaluate the safety, tolerability, pharmacokinetic profile and antitumor activity of SGN-75 in order to identify a dose and schedule for future clinical trials.

SGN-75 is an ADC comprising an anti-CD70 antibody attached to a potent, synthetic drug payload, monomethyl auristatin F (MMAF), using Seattle Genetics’ proprietary technology. The ADC is designed to be stable in the bloodstream, but to release its payload upon internalization into CD70-expressing tumor cells, resulting in targeted cell-killing.

About Non-Hodgkin Lymphoma

Non-Hodgkin lymphoma represents a diverse group of cancers that develop in the lymphatic system and are characterized by uncontrolled growth and accumulation of abnormal lymphocytes. Lymphocytes are white blood cells that are responsible for defending the body against infection. The most common forms of non-Hodgkin lymphoma are follicular and diffuse large B-cell lymphoma. According to the American Cancer Society, approximately 66,000 cases of non-Hodgkin lymphoma are expected to be diagnosed in the United States during 2009 and approximately 19,500 patients will die from the disease.

About Renal Cell Carcinoma

Renal cell carcinoma (RCC) forms in the kidney, which filters and cleans the blood. Metastatic RCC occurs when the cancer has spread to other parts of the body. RCC is the most common type of kidney cancer in adults, representing approximately 90 percent of cases. The American Cancer Society estimates that there will be more than 57,700 new cases of kidney cancer in the United States during 2009, and about 13,000 people will die from the disease.

Source
Seattle Genetics Continue reading →

Amgen (Nasdaq: AMGN) announced it will present detailed data from four Phase 3 studies as well as other data at the ECCO 15 – ESMO 34 European Multidisciplinary Congress, September 20 24, 2009 in Berlin, Germany.

Researchers will present data from two Phase 3 head-to-head studies evaluating denosumab versus Zometa(R) (zoledronic acid) for the treatment of bone metastases in patients with advanced breast cancer (the ’136′ study) and the treatment of bone metastases in advanced cancer patients with solid tumors (not including breast and prostate cancer) or multiple myeloma (the ’244′ study).

Detailed data will also be presented from two Phase 3 studies evaluating Vectibix(R) (panitumumab) in combination with chemotherapy for the first-line and second-line treatment of metastatic colorectal cancer (the ’203′ and ’181′ trials, respectively).

“Amgen is very pleased to be presenting these important data from the denosumab and Vectibix development programs,” said Roger M. Perlmutter, M.D., Ph.D., executive vice president of Research and Development at Amgen. “The data from these trials demonstrate that both denosumab and Vectibix have the potential to improve outcomes in patients suffering from cancer.”

SELECTED ABSTRACTS OF INTEREST

Identified below are selected abstracts of interest on Amgen research. Updated data will be presented at the meeting.

Denosumab

– A double-blind, randomized study of denosumab versus zoledronic acid for the treatment of bone metastases in patients with advanced cancer (excluding breast and prostate cancer) or multiple myeloma

Lead Author: Henry, D

Abstract No. 20LBA (Monday, Sept. 21, 2009, 12:45 -13:00 CEST)

– Denosumab versus zoledronic acid for the treatment of breast cancer patients with bone metastases: Results of a randomized Phase 3 study

Lead Author: Stopeck, A.

Abstract No. 2LBA (Tuesday, Sept. 22, 2009, 14:15 – 14:30 CEST)

– Overall survival in men with and without prevalent vertebral fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer

Lead Author: Smith, M.

Abstract No. 7005 (Monday, Sept. 21, 2009, 12:15 -12:45 CEST)

Vectibix

– Randomized Phase 3 study of panitumumab with FOLFIRI vs FOLFIRI alone as second-line treatment (tx) in patients (pts) with metastatic colorectal cancer (mCRC)

Lead Author: Peeters, M.

Abstract No. 14LBA (Tuesday, Sept. 22, 2009, 10:45 – 11:00 CEST)

– Randomized Phase 3 study of panitumumab with FOLFOX compared to FOLFOX alone as first-line treatment (tx) for metastatic colorectal cancer (mCRC): The PRIME trial

Lead Author: Douillard, J.Y.

Abstract No. 10LBA (Thursday, Sept. 24, 2009, 11:00 – 11:15 CEST)

About Denosumab

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 bone loss and destruction associated with cancer treatment-induced bone loss in breast and prostate cancers, for the prevention of skeletal related events due to the spread of cancer to the bone in multiple myeloma and multiple solid tumors, and for its potential to delay bone metastases in prostate cancer.

In two phase 3 skeletal related events studies reported to date, the incidence of adverse events and serious adverse events was consistent with what has previously been reported for denosumab and Zometa. Osteonecrosis of the jaw (ONJ) was seen infrequently in both treatment groups.

About Vectibix

Vectibix is the first fully human anti-EGFR approved by the U.S. Food and Drug Administration (FDA) for the treatment of mCRC. Vectibix was approved in the United States in September 2006 as a monotherapy for the treatment of patients with EGFR expressing mCRC after disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.

In December 2007, the European Commission granted a conditional marketing authorization for Vectibix as monotherapy for the treatment of patients with EGFR-expressing mCRC with wild-type KRAS genes after failure of standard chemotherapy regimens. Vectibix has been launched in over 20 countries, including Switzerland, Australia and Canada. Applications in the rest of the world are pending.

The effectiveness of Vectibix as a single agent for the treatment of EGFR-expressing, metastatic colorectal carcinoma is based on progression-free survival. Currently no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Vectibix. Vectibix has not shown a treatment benefit for patients whose tumors had KRAS mutations in codon 12 or 13.

Important Product Safety Information

Dermatologic Toxicity: Dermatologic toxicities occurred in 89 percent of patients and were severe (NCI-CTC grade 3 and higher) in 12 percent of patients receiving Vectibix monotherapy. Withhold Vectibix for dermatologic toxicities that are grade 3 or higher or are considered intolerable. If toxicity does not improve to lesser than or equal to grade 2 within 1 month, permanently discontinue Vectibix. The clinical manifestations included, but were not limited to, dermatitis acneiform, pruritus, erythema, rash, skin exfoliation, paronychia, dry skin, and skin fissures. Subsequent to the development of severe dermatologic toxicities, infectious complications, including sepsis, septic death, and abscesses requiring incisions and drainage were reported.

Infusion Reactions: Severe infusion reactions occurred in approximately 1 percent of patients. Severe infusion reactions included anaphylactic reactions, bronchospasm, and hypotension. Although not reported with Vectibix, fatal infusion reactions have occurred with other monoclonal antibody products. Stop infusion if a severe infusion reaction occurs. Depending on the severity and/or persistence of the reaction, permanently discontinue Vectibix.

About Amgen

Amgen discovers, develops, manufactures 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.

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. 16, 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.

Continue reading →

The use of minimally invasive procedures to treat brain blood vessel diseases has made tremendous strides in the past decade along with advances in the field of catheter-based interventions. The American Heart Association/American Stroke Association is providing recommendations for their use based on the best available evidence.

The new statement, published in Circulation: Journal of the American Heart Association, addresses the use of stenting, coil embolization (using metal coils to close off abnormal blood vessels), in-artery delivery of clot busting drugs, and mechanical clot-removing devices for the treatment of:

– brain aneurysms,

– narrowed brain arteries,

– acute ischemic stroke, and

– arteriovenous malformations (abnormal connections between arteries and veins).

A summary of recommendations can be found in Table 2 of the statement:

Indications for the Performance of Intracranial Endovascular Neurointerventional Procedures

Authors of the statement are Philip M. Meyers, M.D., Chair; H. Christian Schumacher, M.D., Co-Chair; Randall T. Higashida, M.D., Co-Chair; Stanley L. Barnwell, M.D., Ph.D.; Mark A. Creager, M.D.; Rishi Gupta, M.D.; Cameron G. McDougall, M.D.; Dilip K. Pandey, M.D.; David Sacks, M.D.; and Lawrence R. Wechsler, M.D.

Continue reading →

HIV-positive head and neck cancer patients respond well to radiation therapy treatments and experience similar toxicity rates as non-HIV-positive patients, despite prior reports to the contrary, according to a study in the January issue of the International Journal of Radiation Oncology-Biology-Physics, an official journal of the American Society for Radiation Oncology (ASTRO).

Patients with HIV have a significantly higher risk of developing some types of cancers; however, since the use of highly active antiretroviral therapy (HAART) began in the mid-1990s, the instances of AIDS-related cancer have greatly decreased. This has alternately caused a higher incidence of these patients developing non-AIDS-related cancers, including those originating from the head and neck.

Radiation therapy constitutes a current standard treatment for head and neck cancer, but there has been very little investigation into how radiation therapy affects HIV-positive patients. Traditionally, aggressive treatment such as radiation therapy has been used sparingly in this population due to concerns regarding acute and late complications. This newly presented research sought to determine the feasibility of radiation therapy and the likelihood of cure for HIV-positive patients with head and neck cancer.

The three-year estimates of overall survival and local-regional control were 78 percent and 92 percent, respectively. Grade 3+ toxicity was reported by 58 percent of patients, but this did not appear worse than the standard rate seen in HIV-negative patients.

The researchers did note that 75 percent of patients studied were receiving HAART therapy at the time of treatment. Also, all patients underwent dental prophylaxis and gastrostomy tube placement before beginning therapy, which may have played a role in the toxicity levels remaining comparable to HIV-negative patients. Dental prophylaxis, gastrostomy tubes, and monitoring of CD4 counts are recommended in these patients to minimize treatment complications.

“It is clear that HIV-positive patients tolerated primary radiation therapy for head-and-neck cancer without excessive toxicity or exaggerated tissue reactions,” Allen Chen, M.D., senior author of the study and training program director at the University of California Davis Cancer Center in Sacramento, California, said. “With HIV-positive patients living longer than ever before and therefore developing cancers unrelated to their HIV, these studies are important to ensure that we are treating these patients for cancer in a way that provides them with the best possible outcomes.”

Continue reading →

Heart transplant recipients’ cardio-respiratory fitness is around 30 to 50 per cent lower than age-matched healthy sedentary individuals. As a result, exercise rehabilitation should be very important to these patients, and a University of Alberta study shows they can improve their overall physical fitness.

Mark Haykowsky, in the Faculty of Rehabilitation Medicine, led the largest randomized exercise intervention trial in heart-transplant patients, which was published in the April edition of American Journal of Transplantation. The study involved 43 participants, half sedentary, and the other half on a 12-week exercise program. He found that exercise improved cardio-respiratory fitness, muscle mass and maximal strength; surprisingly, however, exercise training didn’t improve heart or blood-vessel function. Those exercising improved the size of the muscle mass, but blood vessels were still hardened and the heart’s ability to fill and relax was not improved.

The study’s findings show that people who are classified as “long-term post-transplant” are trainable. The results also served as a springboard for Dwight Kroening, who went on to become the first heart-transplant recipient to complete an Ironman triathlon (2.4 mile swim, 112 mile bike and 26 mile run). And the inspiration goes both ways, as Haykowsky went on to train and complete his first marathon because of Kroening’s own determination.

Continue reading →

While chronic inflammation is widely believed to be a predisposing factor for colon cancer, the exact mechanisms linking these conditions have remained elusive. Scientists at the Melbourne Branch of the international Ludwig Institute for Cancer Research (LICR) and the Technical University Munich have jointly discovered a new piece of this puzzle by demonstrating how the Stat3 protein links inflammation to tumor development, a discovery that may well lead to the identification of new therapeutic targets for colon cancer.

Aberrant activation of the intracellular signaling protein, Stat3, has been associated with inflammation and several cancers, including those of the gastrointestinal tract. The results published on-line today in the journal Cancer Cell provide the first direct evidence confirming the role for Stat3 in inflammation-associated tumorigenesis. Using an inflammation-associated cancer model in genetically manipulated mice, the team identified a relationship between epithelial cell Stat3 activity and colonic tumor incidence, as well as tumor growth. They also determined that stimulation of Stat3 by the cytokines IL-6 and IL-11, chemicals produced by inflammatory and other tumor-associated cells, promotes both cell survival and growth of tumor cells.

The collaboration was sparked by discussions between Professors Matthias Ernst (LICR) and Florian Greten (Technical University Munich) at a scientific meeting, when they discovered they were both individually pursuing the mechanism by which Stat3 links inflammation to gastrointestinal cancers. Rather than compete, the two decided to join forces to discover the Stat3 connection between inflammation and colon cancer.

“Colon cancer is the second most frequent malignancy in the developed world so it was no surprise to find another group working on the Stat3 question and trying to find new ways to target colon cancer,” said LICR’s Professor Ernst, the joint senior author of the publication. “Together we’ve been able to learn how Stat3 bridges chronic inflammation and tumor promotion by mediating cell survival during an inflammatory event and enhancing tumor cell growth. Our new findings are very much in line with our previous work on the role of Stat3 in mediating inflammation- associated gastric cancer. We expect this knowledge to strengthen efforts for the development of therapeutics that target the link between inflammation and cancer to ultimately benefit the treatment of cancer patients.”

Incidentally, the group of Professor Michael Karin from the University of California at San Diego, has reached similar conclusions in paper published in the same issue of Cancer Cell.

About LICR

The Ludwig Institute for Cancer Research (LICR) is the largest international non-profit institute dedicated to understanding and controlling cancer. With operations at 73 sites in 17 countries, LICR’s research network quite literally spans the globe. LICR has developed an impressive portfolio of reagents, knowledge, expertise, and intellectual property, and has also assembled the personnel, facilities, and practices necessary to patent, clinically evaluate, license, and thus translate, the most promising aspects of its own laboratory research into cancer therapies.

Continue reading →

A patient with depression may find it harder to recover his/her heart rate variability after a heart attack, increasing his/her chances of coronary death. Patients who are successfully treated for depression tend to experience improvement in heart rate variability after acute coronary syndromes, compared to depressed patient’s who aren’t (treated for depression), says an article in Archives of General Psychiatry (JAMA/Archives), September issue.

The degree to which your heart rate changes from beat to beat in response to normal impulses is known as your heart rate variability.

The authors wrote “Low heart rate variability predicts death after myocardial infarction (heart attack). It is reduced in depressed compared with non-depressed patients after myocardial infarction and has been proposed to be a mediator of the increased mortality associated with depression.” Patients without depression who have an acute coronary episode experience a fall in heart rate variability – this recovers substantially in the months after an episode (not completely).

Alexander H. Glassman, M.D., of the Columbia University College of Physicians and Surgeons and the New York State Psychiatric Institute, New York, and team looked at 290 patients with depression three weeks after they had been hospitalized for acute coronary syndrome – their heart rate variability was measured. They were then randomly selected to either receive sertraline, which is an antidepressant, or just a placebo, for a period of 24 weeks. At 16 weeks they all had their heart rate variability measured again. The scientists also rated each patient’s depression (for severity) and their clinical response to treatment.

The researchers had found that previous episodes of depression were clearly linked to lower heart rate variability at the beginning of the study. At 16-weeks into the trial those patients who were still suffering from depression had slower heart rate variability recovery rates than those whose depression was either improving or had gone. In fact, some of the still-depressed patients had poorer heart rate variability readings at 16-weeks.

The writers explained “Both sertraline treatment and symptomatic recovery from depression were associated with increased heart rate variability compared with placebo-treated and non-recovered post – acute coronary syndrome control groups, respectively, but this results primarily from decreased heart rate variability in the comparison groups.”

Why there is a link between heart rate variability, depression and cardiac death is unclear, the researchers said. “What is clear is that depression is associated with biological changes involving increased heart rate, inflammatory response, plasma norepinephrine, platelet reactivity, decreased heart rate variability and now absent post – acute coronary syndrome heart rate variability recovery, all of which is associated with life-threatening consequences. Understanding why these characteristics so strongly associate with depression is crucial to understanding the nature of depression itself. From a clinician’s point of view, patients with depression after myocardial infarction, especially those with prior episodes, should be both carefully watched and aggressively treated, because they are at an elevated cardiac risk and less likely to get better spontaneously,” they concluded.

“Heart Rate Variability in Acute Coronary Syndrome Patients With Major Depression Influence of Sertraline and Mood Improvement”
Alexander H. Glassman, MD; J. Thomas Bigger, MD; Michael Gaffney, PhD; Louis T. Van Zyl, MB, ChB, MMed (Psych)
Arch Gen Psychiatry. 2007;64:1025-1031.

Click here to view article online

Continue reading →

Women taking GlaxoSmithKline’s experimental human papillomavirus vaccine, Cervarix — which has been shown in studies to be 100% effective in preventing infection with HPV strains 16 and 18 — have high levels of antibodies against the strains for up to four-and-a-half years after receiving the drug, according to a study published in the April 6 online edition of the journal Lancet, BBC News reports (BBC News, 4/5). The two HPV strains together cause about 70% of cervical cancer cases (Kaiser Daily Women’s Health Policy Report, 2/23). Diane Harper, director of the Gynecologic Cancer Prevention Research Group at Dartmouth Medical School, and colleagues also found that Cervarix has been shown to prevent HPV strains 31 and 45, which together with strains 16 and 18 cause more than 80% of cervical cancer cases (Hall, Toronto Star, 4/6). According to a GSK release, the study shows that protection against strains 31 and 45 also lasts up to four-and-a-half years. Harper and colleagues for up to 53 months followed 776 of the girls and women enrolled in an earlier study on the vaccine (GSK release, 4/6). The results of the previous study were published in the Nov. 13, 2004, issue of the Lancet. The earlier study tested the vaccine on 1,113 girls and women ages 15 to 25 in the U.S., Canada and Brazil. The women were given three doses of Cervarix or a placebo and followed for up to 27 months (Kaiser Daily Women’s Health Policy Report, 11/15/04).

Reaction
“These findings set the stage for widescale adoption of HPV vaccination for prevention of cervical cancer,” Harper said (Reuters, 4/5). GSK has submitted Cervarix for European approval and expects to file for FDA approval in the second half of 2006, Dow Jones reports (Berton, Dow Jones, 4/5). Gary Dubin, GSK vice president for HPV vaccine clinical development and co-author of the study, said the study indicates Cervarix could be a “broader” vaccine, protecting against 80% of cervical cancer cases, the Philadelphia Inquirer reports. However, Merck HPV researcher Eliav Barr said Dubin’s analysis is “unorthodox,” adding that Merck is testing its experimental HPV vaccine, Gardasil, for protection against additional HPV strains (Ginsberg, Philadelphia Inquirer, 4/6). Merck in October 2005 announced that Gardasil in clinical trials was 100% effective in preventing infection with strains 16 and 18. The company in February announced that FDA had granted priority review for Gardasil (Kaiser Daily Women’s Health Policy Report, 2/9). Merck said it expects FDA to act on its application by June 8. Although Merck’s and GSK’s vaccines are “moving closer to the U.S. market,” it will be “years” before researchers know if booster shots of the vaccines will be necessary, USA Today reports. “It’s not surprising that there’s still a strong immune response four years out, Christopher Crum — director of women’s and perinatal pathology at Brigham and Women’s Hospital in Boston who was not involved in the trials — said, adding, “The real question is whether that will be maintained decades later” (Rubin, USA Today, 4/6).

“Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

View drug information on Cervarix [Human Papillomavirus Bivalent; Gardasil. Continue reading →

Prion protein, a form of protein that triggers BSE, is associated with other brain diseases in cattle, raising the possibility of a significant increase in the range of prion disease. Publishing their findings in the open access journal BMC Veterinary Research, scientists have detected changes in the production and accumulation of the prion protein in the brains of cattle with a rare neurodegenerative disorder.

Martin Jeffrey of the Veterinary Laboratories Agency led a research team that tested 15 brains of cattle with idiopathic brainstem neuronal chromatolysis and hippocampal sclerosis (IBNC). They are the first group to show that the brains of animals with this disease accumulate prion protein (PrP), the protein that misfolds to cause BSE and which, when transmitted to humans through the food chain, can cause the deadly Variant Creutzfeldt-Jakob disease

IBNC is a rare neurological disease of adult cattle. It was first characterised in 1988 following laboratory tests from cattle suspected of having BSE. Although IBNC has some clinical similarities to BSE, the brains of affected cattle do not have the neuronal vacuolation (lesions) typical of BSE.

Further laboratory tests suggest that the misfolded form of PrP, which accumulates in the brains of BSE cases, is not present in IBNC cases. Commercial BSE testing kits did not detect the telltale, BSE-inducing form of PrP either. However, the presence of increased levels of PrP was detected.

“We’ve shown for the first time that prion protein is somehow involved in IBNC,” says Jeffrey, “In this disease, there is an association with abnormally high levels of a prion protein in the brain but clearly this PrP is in a different form to that involved in BSE and CJD. This may have implications for diagnosis and recognition of typical forms of BSE as well as the related diseases in sheep, deer and in man.

Notes:

1. Idiopathic Brainstem Neuronal Chromatolysis (IBNC): a novel prion protein related disorder of cattle?
Martin Jeffrey, Belinda Baquero-Perez, Stuart Martin, Linda Terry and Lorenzo Gonzalez
BMC Veterinary Research (in press)
Article available at the journal website: biomedcentral/bmcvetres/
All articles are available free of charge, according to BioMed Central’s open access policy.

2. BMC Veterinary Research is an open access journal publishing original peer-reviewed research articles in all aspects of veterinary science and medicine, including the epidemiology, diagnosis, prevention and treatment of medical conditions of domestic, companion, farm and wild animals, as well as the biomedical processes that underlie their health. BMC Veterinary Research (ISSN 1746-6148) is indexed/tracked/covered by PubMed, MEDLINE, CAS and Google Scholar.

3. BioMed Central (biomedcentral/) is an independent online publishing house committed to providing immediate access without charge to the peer-reviewed biological and medical research it publishes. This commitment is based on the view that open access to research is essential to the rapid and efficient communication of science.

Continue reading →

Thousands of
research studies have documented how the oils known as omega-3 fatty acids
can benefit the cardiovascular system, particularly among people diagnosed
with coronary artery disease. The incredible volume of research on this
topic creates difficulty for many physicians and patients to stay current
with findings and recommendations related to these oils.

In the March issue of Mayo Clinic Proceedings, contributors briefly
summarize current scientific data on omega-3 fatty acids and cardiovascular
health, focusing on who benefits most from their protective effects,
recommended guidelines for administration and dosing, and possible adverse
effects associated with their use.

Two omega-3 fatty acids that have been associated with cardiovascular
benefit, docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), are
found in fish oils. The best source for DHA and EPA are fatty coldwater
fish such as herring, mackerel, salmon and tuna. Fish oil supplements or
algae supplements also can provide omega-3 fatty acids.

Author James O’Keefe, M.D., a cardiologist from the Mid America Heart
Institute in Kansas City, Mo., cites the results of several large trials
that demonstrated the positive benefits associated with omega-3 fatty
acids, either from oily fish or fish oil capsules.

“The most comelling evidence for the cardiovascular benefit provided by
omega-3 fatty acids comes from three large controlled trials of 32,000
participants randomized to receive omega-3 fatty acid supplements
containing DHA and EPA or to act as controls,” explains Dr. O’Keefe. “These
trials showed reductions in cardiovascular events of 19 percent to 45
percent. Overall, these findings suggest that intake of omega-3 fatty
acids, whether from dietary sources or fish oil supplements, should be
increased, especially in those with or at risk for coronary artery
disease.”

How much fish oil should people attempt to incorporate into their
diets? According to Dr. O’Keefe, people with known coronary artery disease
should consume about 1 gram per day, while people without disease should
consume at least 500 milligrams (mg) per day.

“Patients with high triglyceride levels can benefit from treatment with
3 to 4 grams daily of DHA and EPA,” says Dr. O’Keefe. “Research shows that
this dosage lowers triglyceride levels by 20 to 50 percent.”

About two meals of oily fish can provide 400 to 500 mg of DHA and EPA,
so patients who need to consume higher levels of these fatty-acids may
choose to use fish oil supplements to reach these targets.

Dr. O’Keefe also notes that research supports the effectiveness of
combining the consumption of fish oil with the use of cholesterol-lowering
medications called statins. Combination therapy with omega-3 fatty acids
and a statin is a safe and effective way to improve lipid levels and
cardiovascular health beyond the benefits provided by statin therapy alone.
Blood DHA and EPA levels could one day be used to identify patients with
deficient levels and to individualize therapeutic recommendations.

Dr. O’Keefe found little evidence of serious adverse effects associated
with fish oil consumption. “In prospective placebo-controlled trials, no
adverse effects were observed to occur at a frequency of more than 5
percent, and no difference in frequency was noted between the placebo and
omega-3 fatty acid groups,” he says.

The most commonly observed side effects include nausea, upset stomach
and a “fishy burp.” Taking the supplement at bedtime or with meals, keeping
fish oil capsules in the freezer or using enteric-coated supplements may
help reduce burping and upset stomach symptoms.

A peer-review journal, Mayo Clinic Proceedings publishes original
articles, reviews and editorials dealing with clinical and laboratory
medicine, clinical research, basic science research and clinical
epidemiology. Mayo Clinic Proceedings is published monthly by Mayo
Foundation for Medical Education and Research as part of its commitment to
the medical education of physicians. The journal has been published for
more than 80 years and has a circulation of 130,000 nationally and
internationally. Articles are available online at
mayoclinicproceedings.

Mayo Clinic Proceedings
mayoclinic Continue reading →