Trilipix With Statin No Better Than Statin Alone? FDA Panel Meets This Week



Abbot's blockbuster cholesterol drug, Trilipix (fenofibrate), which is taken in combination with a statin was found to be no better at reducing heart attack risk than taking the statin alone, in a trial involving diabetic patients. An FDA Advisory Committee will meet this week to decide whether the FDA should alter the drug's key indication.

Trilipix lowers LDL (low-density lipoprotein) as well as VLDL (very low density lipoprotein), and increases HDL (high-density lipoprotein). It also reduces triglyceride levels. The drug is a fibrate.

It is approved by the FDA to be used in combination with statins.

A government-funded study involving 5,000 patients with diabetes divided participants into two groups. One group received both Trilipix plus a statin, while those in the other group were given just the statin. The researchers reported that heart attack rates were the same in both groups - adding the Trilipix to the medication mix did not appear to reduce heart attack risk.

The FDA Advisory Committee has been asked by the FDA to review data on Trilipix and decide whether the labeling should be updated and whether its approval for use with statins should be rescinded.

The Advisory Committee can only recommend, whatever it says is not binding. However, the FDA usually goes along with its advice.

The study also revealed that females who took the combination Trilipix plus a statin had a higher heart attack risk than female patients on statins alone. The FDA has asked the Committee to discuss those data.

May 19, 2011: Endocrinologic and Metabolic Drugs Advisory Committee Meeting Announcement

Abbott Laboratories points out that two-thirds of the participating patients in the study would not have been eligible for Trilipix according to prescribing guidelines.

Written by Christian Nordqvist View drug information on Fenofibrate; Trilipix.

Regular Coffee Reduces Lethal Prostate Cancer Risk




A man who drinks either caffeinated or decaffeinated coffee regularly has a significantly lower chance of developing a more aggressive from of prostate cancer, researchers from the Harvard School of Public Health revealed in the Journal of the National Cancer Institute. This study follows another one last week that linked regular coffee drinking with a lower risk of a particular type of breast cancer.

The aggressive (lethal) cancer referred to here is the one that spreads to the bones.

Senior author, Lorelei Mucci wrote:"Few studies have specifically studied the association of coffee intake and the risk of lethal prostate cancer, the form of the disease that is the most critical to prevent. Our study is the largest to date to examine whether coffee could lower the risk of lethal prostate cancer."

Prostate cancer is the most commonly diagnosed male cancer in the USA, and the country's second biggest cancer killer, after lung cancer. 16 million males worldwide are cancer survivors; 2 million are American.

Lead author, Kathryn Wilson said:"At present we lack an understanding of risk factors that can be changed or controlled to lower the risk of lethal prostate cancer. If our findings are validated, coffee could represent one modifiable factor that may lower the risk of developing the most harmful form of prostate cancer."

Coffee contains several compounds which regulate insulin, reduce swelling (inflammation), and act as antioxidants - all considered beneficial regarding prostate cancer risk. Hence, the scientists chose to study it.

Apart from the breast cancer protecting qualities revealed last week, previous studies have also shown that coffee reduces the risk of developing diabetes type 2, gallstone disease, Parkinson's disease, liver cancer, and cirrhosis of the liver.

The researchers set out to determine whether prostate cancer might help protect against prostate cancer, especially its aggressive form. They gathered data on 47,911 American adult males from the Health Professionals Follow-Up Study. This database included coffee consumption habits from 1986 to 2008. 5,035 prostate cancer cases were reported during this period, of which 642 were aggressive (metastatic) or fatal cases.

The authors found that: Adult males who drank at least six cups of coffee a day had an almost 20% lower chance of developing any type of prostate cancer.Those drinking at least six cups of coffee a day had a 60% lower chance of developing the aggressive/lethal form of prostate cancer.The risk reduction was seen equally among both drinkers of caffeinated and decaffeinated coffee.Moderate coffee drinkers (1 to 3 cups per day) had a 30% lower chance of developing lethal prostate cancerThe authors add that further validation studies in other populations are needed to confirm their findings. If confirmed, then prostate cancer protection should be added to the benefits of regular coffee drinking.

"Coffee Consumption and Prostate Cancer Risk and Progression in the Health Professionals Follow-up Study"
Kathryn M. Wilson, Julie L. Kasperzyk, Jennifer R. Stark, Stacey Kenfield, Rob M. van Dam, Meir J. Stampfer, Edward Giovannucci, Lorelei A. Mucci
Journal of the National Cancer Institute, online May 17, 2011. doi: 10.1093/jnci/djr151

Written by Christian Nordqvist

Too Posh To Push? The Increasing Trend For Caesarean Section

During the last thirty years there has been an increase in the number of babies born by Caesarean section. New research published in BioMed Central's open access journal BMC Public Health shows that there has also been a change in the social and economic status of the mothers involved and that advantaged mothers are more likely to have their babies by Caesarean section than mothers living in more difficult circumstances.

Birth by Caesarean section can be a lifesaver for both mum and baby, however there are risks involved in such a major abdominal surgery and increased costs due to extended hospital stays for both mother and child. Researchers from the Medical Research Council/Chief Scientist Office Social and Public Health Sciences Unit (MRC/CSO SPHSU) looked at the mother's social class, and the level of deprivation of the area each mother lived in. This data was compared to patient records describing hospital births and patient records covering details about the pregnancy and delivery. Social class was obtained from the parent's occupation listed on the child's birth certificates and level of deprivation was calculated for each mother's postcode from the relevant census.

Ruth Dundas from the MRC/CSO SPHSU, said, "Thirty years ago mothers having Caesarean sections were more likely to come from deprived areas and/or from a lower social background. This was true for both elective and emergency sections. Ten years later the rates had changed so that, although women from a lower social background were more likely to have emergency sections, there was no difference between them and women from a higher social background in elective surgery rates. By 1999-2000 the rates had equalized for emergency section, but babies born by elective surgery were more likely to belong to mothers from the higher of the social classes measured."

She continued, "The disappearance of social trends for emergency Caesarean section reflects increased equality in health care. However this does not explain the differences seen for elective section nor the differences seen between health boards. It is important to ensure that the clinical decision making process is the same for all women, regardless of their background, so that they all have equal chance of the best medical care."

"The influence of both individual and area based socioeconomic status on temporal trends in Caesarean sections in Scotland 1980-2000"
Lesley Fairley, Ruth Dundas and Alastair H Leyland
BMC Public Health

National Osteoporosis Society Issues Comment On RCP Audit Findings On Fracture Preventative Care

An audit carried out by the Royal College of Physicians' has revealed that too many NHS Trusts are failing to prevent recurrent falls and fractures. The audit, commissioned by the Healthcare Quality Improvement Partnership (HQIP), also found that many patients who could benefit from treatment to prevent broken bones are missing out.

Juliette Brown, Director of Communications and Public Affairs for the National Osteoporosis Society said:

"Whilst it is encouraging to see that there has been some improvement, these findings show unacceptable gaps in the provision of care that will result in needless pain, disability and premature deaths. As well as the human cost, we know that dedicated services to assess fracture patients for fragile bones can save the NHS money. By assessing people early, the huge cost of treating further fractures can be avoided. It's an obvious solution to a huge problem that could be tackled by including osteoporosis in the UK-wide GP contract, through the Quality and Outcomes Framework.

2/3 of older people who had fractured a wrist, arm, pelvis or spine were missing out on the opportunity to access treatment to prevent more broken bones.

40% of hip fracture patients were also missing out on treatment.

Every year there are 300,000 fractures due to fragile bones, many of which could be prevented.

Every month, 1,150 people are dying prematurely as a result of hip fractures.

The cost to the NHS is huge too, the combined cost of hospital and social care for patients with a hip fracture amounts to more than £2.3billion per year in the UK - that's approximately £6 million a day.

Source
The National Osteoporosis Society

'Blueprint' For Blocking MMP May Unlock New Treatments For Deadly Blood Infection

Researchers studying the life threatening infectious disease sepsis have discovered how the infection can lead to a fatal inflammatory response through blood vessel cells. The research, which is published in EMBO Molecular Medicine, focuses on blocking crucial Matrix Metalloprotease enzymes (MMP) which activate the response.
Sepsis, and the associated systemic inflammatory response syndrome (SIRS), is a deadly condition caused by an infection of the blood which leads to whole-body inflammation. The condition is a major cause of death in intensive care wards worldwide and is most common in elderly and critically ill patients, as well as patients who are immunocompromised.
"Sepsis is a deadly disease, yet the underlying mechanisms which allow it to change body functions remains poorly understood and this has blocked the advancement of potential treatments," said lead author Athan Kuliopulos, from Tufts Medical Center and Tufts University School of Medicine, Boston. "One such mechanism is the inability of the body to regulate the inflammatory-coagulation response to the infection, which can seriously damage the patient."
The team focused their research on Matrix Metalloprotease-1 (MMP-1) which plays a key role in the immune systems response to invading pathogens and infectious diseases, but can cause uncontrolled tissue damage, which threatens the life of patients.

The study revealed how human sepsis patients have been found to have elevated levels of proMMP-1 and active MMP-1 in blood plasma which predicted both early and late death at 7 and 28 days after diagnosis.

By studying infected mice the team examined how MMP-1 was released from endothelial cells, the thin layer of cells which cover the interior surface of blood vessels. The team found that the blocking of MMP-1 activity suppressed endothelial barrier disruption, helped prevent lung failure, and improved survival in mice.

"We made the discovery that MMP-1, and its mouse equivalent MMP-1a, activates protease-activated receptors which contribute to the pro-inflammatory response of the body to sepsis through endothelial cells," said Kuliopulos. "By blocking the mouse MMP-1 we significantly improved the survival of the mice thus demonstrating a dependence on MMP-1."

The findings reveal MMP-1 to be an important early activator and suggest that therapeutics which target MMPs may prove beneficial in the treatment of sepsis.
"Sepsis remains a common, difficult to manage and stubbornly persistent syndrome when caring for critically ill patients," said Kuliopulos. "This discovery that MMP-1 acts as an activator provides us with a blueprint to investigate entirely new types of treatment for sepsis patients."
Citation
"A matrix metalloprotease-PAR1 system regulates vascular integrity, systemic inflammation and death in sepsis"
Tressel. S, Kaneider. N, Kasuda. S, Foley. C, Koukos. G, Austin. K, Agarwal. A, Covic. L, Opal. S, Kuliopulos. A,
EMBO Molecular Medicine, Wiley-Blackwell, May 2011, DOI: 10.1002/emmm.201100145

States Sign On With Text4baby To Deliver Mobile Health Information Into The Hands Of New & Expecting Moms

Text4baby, the free mobile health service, is making it much easier for pregnant women and new moms to connect with the care they need. By simply texting "BABY" (or "BEBE" for information in Spanish) to 511411, women can register to receive weekly text messages, timed to their individual due dates or their baby's birth date throughout their pregnancy and baby's first year. The tips and messages, which have been developed in collaboration with government and nonprofit health experts, deal with nutrition, immunization and birth defect prevention, among other topics.

Each day in America:

- 11,686 babies are born
-1,487 babies are born preterm
- 964 babies are born with low birthweight
- Only 63% of mothers under age 20 get adequate pre-natal care.

From May until October 2011, states around the nation will be looking for innovative ways to encourage moms to engage with the text4baby program, as part of a recently launched national competition to get moms to sign up and join the movement. The State Enrollment Contest brings together over 500 text4baby partners to help spread the word about maternal and infant health. The top three states to enroll the most users in text4baby between now and the end of October 2011 will be announced at the American Public Health Association Annual Meeting in Washington, DC in November.

An updated text4baby website will help track state-by-state enrollment and partners will be able to access hyper-local statistics by ZIP code. Participants across the country will be able to check in with the site (http://www.text4baby.org), which re-launched today in English to learn more about the contest and activities in their area. The website will also be available in Spanish later this year.

"Every day there is a new group of women who find out they are pregnant, and there is so much that moms need to know. Text4baby is free service that makes motherhood a little easier," said Judy Meehan, CEO National Healthy Mothers Healthy Babies Coalition. "The State Enrollment Contest is an exciting opportunity to reach as many users as possible through healthy competition among the states and the over 500 text4baby partners."

Here are some ways to support your state and be part of the text4baby movement:

- Sign up for text4baby
- Share text4baby on Twitter (@mytext4baby) along with the hashtag #T4B2011
- Become a fan of text4baby on Facebook
- Talk to your local healthcare provider about the text4baby service
- Share text4baby with friends and family

About the State Enrollment Contest:

This state contest grew out of the enthusiasm of text4baby partners and their support for promoting text4baby as a valuable tool for improving maternal and infant health. All fifty states have a chance to join the contest. Enrollment is weighted by pregnancy and birth rates in each state. The State Enrollment Contest is supported by the U.S. Department of Agriculture, National WIC Association, Association of Maternal and Child Health Programs (AMCHP), National Healthy Start Association (NHSA), March of Dimes, National Association of County and City Health Officials (NACCHO), National Alliance for Hispanic Health, and CityMatCH.

Source:
National Healthy Mothers, Healthy Babies Coalition
text4baby

DBV Demonstrates Ability Of VIASKIN(R) To Administer Allergen Via Intact Skin Bytargeting Dendritic Cells For Safe Treatment Of Allergic Disease

DBV Technologies, an emerging biotechnology company, announced today that a study1-"Epicutaneous Immunotherapy (EPIT) Results in Rapid Allergen Uptake by Dendritic Cells through Intact Skin and Downregulates the Allergen-Specific Response in Mice"-published in the Journal of Immunology confirms the safety of the Company's VIASKIN® epicutaneous immunotherapy (EPIT) approach to desensitizing against peanut allergy via a novel and patented skin patch.

DBV is the only company in the world whose products are designed to epicutaneously (via a skin patch) deliver allergens for Epicutaneous Immunotherapy (EPIT) against food allergies such as peanut and milk. Allergen-specific immunotherapy is the only strategy that treats the underlying cause of an allergic disorder. DBV's proprietary epicutaneous patch technology - VIASKIN® - involves maintaining an allergen on the intact skin of an allergic subject for repeated and prolonged periods in order to obtain clinical desensitization to the targeted allergen.

"Since there are no known treatments for food allergies, many children and their families live with the constant fear of ingesting a life-threatening food," said Pierre-Henri Benhamou, M.D., co-founder and CEO of DBV Technologies. "VIASKIN® is designed to trigger the desired immune response while avoiding the risk of a systemic, life-threatening reaction. The evidence published in the esteemed peer-reviewed Journal of Immunology fortifies our ongoing development efforts for VIASKIN®."

About VIASKIN® Technology

When the VIASKIN® patch containing a specific allergen is applied to the skin of a patient with an IgE-mediated allergy - such as peanuts or milk - the allergens are deposited locally on the skin and are captured specifically by the skin's immuno-competent cells. This triggers the modulations of the immune responses. The epicutaneous exposure is non-invasive: the skin naturally prevents the allergen from entering the bloodstream and thereby dramatically reduces the risk of inducing anaphylaxis. The VIASKIN® patch is designed to be easily and painlessly applied by healthcare professionals and also by the patient or his/her parents at home, which facilitates compliance with the treatment.

About VIASKIN® Peanut Immunotherapy

A phase 1b clinical study of VIASKIN® Peanut is underway at five centers in the U.S. - Duke University Medical Center, National Jewish Medical Research Center, Arkansas Children's Hospital, CRI Worldwide, and Aspen Clinical Research. VIASKIN® Peanut's development is also supported by the NIH-funded Consortium of Food Allergy Research (CoFAR) and other opinion leaders in allergy in the United States.

About DBV Technologies

DBV Technologies is the only company in the world whose products are designed to epicutaneously deliver on intact skin - via an epicutaneous patch - allergens for Epicutaneous Immunotherapy (EPIT) against food allergies. Allergen-specific immunotherapy is the only strategy that treats the underlying cause of an allergic disorder. DBV's proprietary epicutaneous patch technology - VIASKIN® - involves maintaining an allergen on the skin of an allergic subject for repeated and prolonged periods in order to obtain clinical desensitization.

1. "Epicutaneous Immunotherapy (EPIT) Results in Rapid Allergen Uptake by Dendritic Cells through Intact Skin and Downregulates the Allergen-Specific Response in Mice", J Immunol; 14 April 2011; V. Dioszeghy et al.

Note: VIASKIN® Peanut is only for investigational use at the moment in the USA and in Europe.

Source:
DBV demonstrates

EnVivo Announces Positive Phase 2b Clinical Data In Schizophrenia


EnVivo Pharmaceuticals announced today positive topline results of its randomized, placebo-controlled Phase 2b clinical trial of EVP-6124, its potent, orally bioavailable and selective alpha-7 agonist, in patients with schizophrenia. The data showed that EVP-6124 had a clinically meaningful and statistically significant impact on patients' overall cognition - the trial's pre-specified primary endpoint - when taken in combination with second-generation antipsychotics and as measured by the full CogState overall cognitive index, or "OCI" (p=0.05 for all patients treated with EVP-6124 versus placebo.) This positive effect on the OCI was supported by a strong positive trend for improved cognition on the MCCB Battery of cognition tests, which were conducted on all U.S. patients in the trial.

Additionally, results from this Phase 2b trial demonstrated that patients treated with EVP-6124 showed clinically meaningful and statistically significant effects in key secondary endpoints: improvement in clinical function (as assessed by the Schizophrenia Cognition Rating Scale (SCoRS)) and reduction of the negative symptoms of schizophrenia (as measured by the Negative Symptom Scale of the Positive and Negative Symptoms Scale (PANSS)). Importantly, EVP-6124 was generally safe and well-tolerated over the trial's three-month dosing period.

"The often devastating effect of schizophrenia on the vocational and social function of patients, and the toll it takes on their families and society is undeniable. Much evidence points towards cognitive dysfunction as the principal cause of the functional decline in most patients. Hallucinations and delusions impact function to a lesser extent than does cognition. Present therapies address these symptoms but have a significantly weaker effect on the cognitive deficit. Thus, the effort to improve outcomes in schizophrenia has focused on developing safe and effective treatments for cognitive impairment, expecting them to lead to improved function and quality of life," said Herbert Y. Meltzer, M.D., Ph.D., the Bixler/May/Johnson professor of psychiatry at Vanderbilt University. "EVP-6124 represents a novel, rational approach, supported by extensive basic research, to improve cognition in schizophrenia. This initial clinical trial is highly encouraging that this novel approach has the potential to address what many consider the greatest unmet pharmacologic need for schizophrenia."

Schizophrenia is a psychiatric disorder that affects approximately 2.4 million Americans, or about one percent of the adult population, and is usually diagnosed between the ages of 15 and 35 years old. Symptoms of schizophrenia include positive and negative symptoms as well as cognitive impairment. "Positive" symptoms include hallucinations, delusions and paranoia. "Negative" symptoms include loss of motivation and interest in everyday activities, blunting of emotion, decrease in speech, and social withdrawal. Increasingly, cognitive impairments such as difficulty paying attention, memory loss and problems processing information and making decisions are also recognized as core disabling symptoms of the disease. The overall annual cost of schizophrenia in the U.S. is more than $62 billion according to a study published in the Journal of Clinical Psychiatry.

Cell Phones Can Help Under-Developed Countries Manage Diabetes And Other Diseases

A new study by the Veterans Affairs Ann Arbor Healthcare System and University of Michigan suggests that mobile phones could help low-income patients across the globe manage diabetes and other chronic diseases.

"Telehealth programs have been shown to be very helpful in a variety of contexts, but one of the main limitations for delivering these services in the developing world has been a lack of infrastructure," says lead study author John D. Piette, Ph.D., a senior research scientist with the VA and professor of internal medicine at the U-M Medical School.

For this study, researchers took advantage of the broad penetration of cell phones in Latin America and paired them with low-cost internet-based phone calls. The service used a cloud computing approach so that the program can be provided from a central location to low income countries around the globe that lack a strong technological infrastructure.

To test the service, the researchers enrolled patients with diabetes from a clinic in a semi-rural area of Honduras. Patients received weekly, automated, interactive phone calls and overwhelmingly reported that the program helped them to improve their diabetes management and general health.

Over the six-week study, researchers saw a clinically important improvement in patients' hemoglobin A1C, a measure of blood sugar control. The results are forthcoming in the June issue of the American Journal of Preventive Medicine.

"We wanted to demonstrate that it was possible to deliver a high-tech program from U-M to very vulnerable patients with diabetes in Honduras who only have local cell phone service," Piette says.

The developing world faces a cardiovascular disease crisis as fast food becomes ubiquitous and people shift to urban centers and less active modern lifestyles. Worldwide, the number of people with diabetes is expected grow from 285 million to 439 million by 2030.

The patients who used the program the most were the ones who had higher blood pressure at the outset, had more severe diabetes and lived farther away from the clinic, says Piette, who is also associate director for global health communications at the U-M Center for Global Health. On average, the patients in the study had only five years of formal education and annual household incomes of $2,500.

Patients also had the option of enrolling in the program with an informal caregiver or CarePartner, who also received calls to their cell phones informing them of how the patient was doing and providing suggestions for how they could help support the patient's self-care.

The research builds on previous work by Piette and co-author Milton Mendoza, M.D., president of Yojoa International Medical Center in Santa Cruz de Yojoa, Honduras. They found that despite poverty and high levels of unemployment, 78 percent of 624 chronically ill primary care patients surveyed had access to cell phones. More than 80 percent of patients expressed interest in receiving automated calls reminding them about appointments, making sure they were taking their medicine, providing educational information and helping them to self-monitor their health.

Those findings were echoed in their new research: 92 percent of patients who completed follow-up surveys said they would use the service again.

"We believe the work of Dr. Piette and his colleagues represents an important and sustainable milestone in innovative global health strategies for the prevention, diagnosis, and management of non-communicable diseases," says U-M Global Health Director Sofia D. Merajver, M.D., Ph.D. "This work truly stands the chance to improve the health of millions of people in a relatively short time."

Piette says future research will examine the program's success against a control group and extend the study period over a longer time period.

Additional authors: Martha Ganser, M.S., Muhima Mohamed, Nicolle Marinec, M.P.H., Sheila Krishnan, M.P.H., all of U-M.

Funding: U-M School of Public Health Global Health Summer Internship Program, and National Institutes of Health grants via the Michigan Diabetes Research and Training Center, and the Michigan Institute for Clinical and Health Research.

Disclosures: None.

Citation: "A Preliminary Study of a Cloud-Computing Model for Chronic Illness Self-Care Support in an Underdeveloped Country," American Journal of Preventive Medicine, June 2011.

Source:
University of Michigan Health System

That Anxiety May Be In Your Gut, Not In Your Head


For the first time, researchers at McMaster University have conclusive evidence that bacteria residing in the gut influence brain chemistry and behaviour.

The findings are important because several common types of gastrointestinal disease, including irritable bowel syndrome, are frequently associated with anxiety or depression. In addition there has been speculation that some psychiatric disorders, such as late onset autism, may be associated with an abnormal bacterial content in the gut.

"The exciting results provide stimulus for further investigating a microbial component to the causation of behavioural illnesses," said Stephen Collins, professor of medicine and associate dean research, Michael G. DeGroote School of Medicine. Collins and Premysl Bercik, assistant professor of medicine, undertook the research in the Farncombe Family Digestive Health Research Institute.

The research appears in the online edition of the journal Gastroenterology.

For each person, the gut is home to about 1,000 trillium bacteria with which we live in harmony. These bacteria perform a number of functions vital to health: They harvest energy from the diet, protect against infections and provide nutrition to cells in the gut. Any disruption can result in life-threatening conditions, such as antibiotic-induced colitis from infection with the "superbug" Clostridium difficile.

Working with healthy adult mice, the researchers showed that disrupting the normal bacterial content of the gut with antibiotics produced changes in behaviour; the mice became less cautious or anxious. This change was accompanied by an increase in brain derived neurotrophic factor (BDNF), which has been linked, to depression and anxiety.

When oral antibiotics were discontinued, bacteria in the gut returned to normal. "This was accompanied by restoration of normal behaviour and brain chemistry," Collins said.

To confirm that bacteria can influence behaviour, the researchers colonized germ-free mice with bacteria taken from mice with a different behavioural pattern. They found that when germ-free mice with a genetic background associated with passive behaviour were colonized with bacteria from mice with higher exploratory behaviour, they became more active and daring. Similarly, normally active mice became more passive after receiving bacteria from mice whose genetic background is associated with passive behaviour.

While previous research has focused on the role bacteria play in brain development early in life, Collins said this latest research indicates that while many factors determine behaviour, the nature and stability of bacteria in the gut appear to influence behaviour and any disruption , from antibiotics or infection, might produce changes in behaviour.

Bercik said that these results lay the foundation for investigating the therapeutic potential of probiotic bacteria and their products in the treatment of behavioural disorders, particularly those associated with gastrointestinal conditions such as irritable bowel syndrome.

The research was funded by grants from the Canadian Institutes of Health Research (CIHR) and the Crohn's and Colitis Foundation of Canada (CCFC).

Source:
McMaster University

Potentially Disruptive Polymer-Based Bioresorbable Stent Data To Be Presented At EuroPCR 2011


Arterial Remodeling Technologies ("ART") announced today that details of the state-of-the-art design of its potentially disruptive polymer-based bioresorbable stent platform will be revealed, for the first time, at EuroPCR 2011 from the podium tomorrow (Wednesday, May 18). The disclosure will be presented by Antoine LaFont, M.D., Ph.D., Professor of Medicine, Head Interventional Cardiology Department, Georges Pompidou Hospital (Paris); and, Past Chairman, Interventional Cardiology Group, European Society of Cardiology (ESC). Dr. LaFont is a co-founder of ART.

Additionally, on Thursday, May 19, also at EuroPCR, Dr. LaFont will make a second presentation from the podium, disclosing additional data that further validates ART's innovative approach to simultaneously balance biocompatibility, biomechanics and bioresorption in a bioresorbable PLA (polylactic acid) stent. These data will show that ART's PLA-based stent can be overexpanded by up to 25% without any problems, thus avoiding the serious medical issues caused by cracking or malapposition.

"We will debunk the myth that polymer based stents are not optimal as a bioresorbable scaffold. Indeed, we have proven that overexpansion limitations are technology related and most definitely not related to the use of polymers in bioresorbable stents. Indeed, this represents a seminal truth, that precise vessel-sizing at implantation is not necessary with our bioresorbale stent due to its crack- and malapposition-free overexpansion features," said Machiel van der Leest, CEO, who previously was a co-founder and Chief Technology Officer of Minvasys. During his career he has developed and successfully introduced 15 Class III medical devices, which required pre-market approval and a scientific review to ensure safety and effectiveness.

"ART's stent is designed to have several critically important competitive advantages over currently marketed and in-development bioresorbable stents, including that our stent is designed to have (1) faster and smoother resorption, and (2) crack- and crazing-free expansion-which are very significant competitive advantage for our bioresorbable stent," explained van der Leest.

ART's novel biopolymers have been developed in conjunction with one of the world's leading authorities in polymer chemistry, Professor Michel Vert, who is Former Director of the Research Center for Artificial Biopolymers at France's National Center for Scientific Research (Centre National de Recherche Scientifique/CNRS).

Source:
Arterial Remodeling Technologies

Missing DNA 'Mechanic' Key Driver In Lymphomas





Cancer Research UK scientists have discovered how a protein in immune cells plays an essential role in their development by repairing DNA damage - and if this protein is missing lymphomas can form. The research, published online in Cancer Cell today1, showed that the protein, called ATMIN, acts as a cell's 'mechanic' looking out for damage in DNA. When it spots damage, ATMIN prompts the cell to repair the DNA by recruiting another protein called ATM.

But without ATMIN, B cells2 do not recognise DNA damage and are unable to activate ATM to begin repairs. Instead the cell attempts to use different repair processes not designed to mend this damage.

This botched repair results in mistakes, causing parts of the DNA structure to be permanently damaged through deletions, gaps and breaks in the sequence. And as these cancer causing changes to the DNA structure accumulate, B cell lymphomas form.

Lead researcher, Dr Axel Behrens from Cancer Research UK's London Research Institute, said: "Our findings reveal more about how this cellular 'mechanic' keeps DNA damage in check in the cell. ATM normally responds to changes in chromatin - the structure that packages the DNA into the cell - by repairing damage. Or if the damage can't be repaired, ATM prevents the cell from replicating and 'scraps' the cell. But, critically ATM can only work if switched on by ATMIN."

The researchers also found that ATMIN appears to play a role in human B cell acute lymphoblastic leukaemia (B-ALL). It is present only at very low levels in B-ALL cells compared to normal cells, suggesting that these findings could have a real impact on understanding the disease.

Dr Julie Sharp, senior science information manager at Cancer Research UK, said: "Revealing the inner workings of cells is essential to understanding how cancers develop. Understanding the role that ATMIN plays will be crucial in developing new and better treatments for lymphomas."

Reference

1. Loizou et al,. ATMIN is required for maintenance of genomic stability and suppression of B Cell lymphoma, Cancer Cell (2011)

Notes

2. B cells are a type of lymphocyte, a key part of the immune system. Their role is to make antigens in response to pathogens that invade the body. It is errors in these cells that lead to lymphomas.

Source:
Cancer Research UK

Can Lifestyle Counselling Prevent Adverse Outcomes In Pregnant Women At High Risk?


In this week's PLoS Medicine, Riitta Luoto and colleagues from the UKK Institute for Health Promotion Research, and University of Tampere, Finland, evaluate whether lifestyle interventions can reduce the risk of high birthweight babies and gestational diabetes amongst pregnant women at high risk for these outcomes.

They report the results of a cluster randomized trial in which groups of maternity clinics in 14 municipalities in Finland were randomized to an intervention. The intervention comprised physical activity and dietary counselling, and was compared with a control arm in which usual care was offered. The researchers find that babies born to women in the intervention arm had a roughly 44% reduced risk of being large for gestational age. However, they failed to show that the lifestyle interventions resulted in a reduced risk of gestational diabetes in women participating in the trial.

The authors comment that "The findings of our study emphasize counseling on the topics of physical activity, diet, and weight gain in maternity care especially for women at risk for gestational diabetes in order to prevent large for gestational age newborns possibly causing problems in delivery, and both the mother's and the child's later weight development".

A video of the authors presenting their findings is available at http://www.mediastage.fi/ukk_luoto

Funding: The main sources of funding in this study are (Finnish) Diabetes research fund, Competitive research funding from Pirkanmaa hospital district, Academy of Finland, Ministry of Education and Ministry of Social Affairs and Health. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Competing Interests: The authors have declared that no competing interests exist.

Citation:
"Primary Prevention of Gestational Diabetes Mellitus and Large-for-Gestational-Age Newborns by Lifestyle Counseling: A Cluster-Randomized Controlled Trial"
Luoto R, Kinnunen TI, Aittasalo M, Kolu P, Raitanen J, et al. (2011)
PLoS Med 8(5): e1001036. doi:10.1371/journal.pmed.1001036

Geneva: Gates Keynotes WHO Meeting, Focus On Child Vaccinations


The 64th World Health Assembly is this week in Geneva, Bill Gates in a keynote address called on government leaders to increase their investments in vaccines and to hold themselves accountable for extending the benefits of vaccines to every child.

In his delivery, he stated:
"Vaccines are inexpensive, they are easy to deliver, and they are proven to protect children from disease. The best immunization systems work because leaders hold themselves accountable for results. Leaders diagnose weaknesses, innovate to address them, and spread the best ideas."

Gates laid out his vision for the impact that broadening access to vaccines can have on the world. Recognizing that leadership is essential to achieving his vision, Gates announced that starting in 2012, his foundation would bestow an award on an individual or organization that has made a uniquely innovative contribution to the Decade of Vaccines. The innovation could be in the science, the delivery, or the financing of vaccines.

Gates continued:
"Strong immunization systems will put an end to polio and help us reach all children with five to six new vaccines. We can save four million lives by 2015, and 10 million lives by 2020. I believe we have the opportunity to make a new future in which global health is the cornerstone of global prosperity."


Gates in particular cited leaders in India and Nigeria who are responsible for increasing immunization rates in their states, and praised the success of the new Meningitis A vaccine that was rolled out in Burkina Faso, Mali and Niger last December, to emphasize the importance of commitments to immunization.

Gates also called on pharmaceutical manufacturers to commit to making sure vaccines are affordable for poor countries. Simply, pharmaceutical companies to make sure vaccines are affordable for poor countries. Specifically, they must make a commitment to affordable pricing. Gates said he was confident that the combined price of the pentavalent, pneumococcus, and rotavirus vaccines can be cut in half by 2015.

In addition Gates said that all 193 WHO member states need to make vaccines a central focus of their health systems. He said they must pledge to meet vaccine coverage targets of 90% at the country level with no district below 80%, and ensure that all children have access to existing vaccines and to new ones as they become available.

In the convention's opening statement, Dr. Margaret Chan, Director-General of the World Health Organization touched on one such vaccine that The Gates Foundation assisted with in Africa late 2010:
"Epidemic meningitis is not the biggest killer in Africa, but it is among the most greatly feared of all diseases. The people of Africa deserve better, and in December of last year they got it: a powerful new vaccine that can prevent epidemics in Africa's notorious meningitis belt. In a project coordinated by WHO and PATH, funded by the Bill and Melinda Gates Foundation, the vaccine was developed, in record time, and at about one-tenth of the cost usually needed to bring a product through development to the market. This offers evidence of a welcome new trend. Africa is the first to receive the best technology that the world, working together, can offer. Remember the people infected with a drug-resistant form of tuberculosis or co-infected with HIV who had to wait up to three months for a reliable diagnosis."
Sources: The World Health Organization and The Melinda and Bill Gates Foundation
Written by Sy Kraft