GTx Announces Toremifene 80 Mg Phase III ADT Clinical Trial Data To Be Presented At The Annual Meeting Of The American Urological Association

GTx, Inc. (NASDAQ: GTXI) announced that data from the Phase III clinical trial evaluating toremifene 80 mg for the prevention of fractures in men with prostate cancer on androgen deprivation therapy will be the subject of an oral podium presentation at the 2009 Annual Meeting of the American Urological Association being held in Chicago April 25 – 30.

- Abstract #639 – “Positive fracture reduction trial of toremifene 80 mg in men on ADT demonstrates significant fracture risk in untreated placebo group”

- Sunday, April 26, 2009, 3:30 – 5:30 p.m. Central Time

- McCormick Place Chicago, Room W475 AB

GTx, Inc.

Behavioral Health Research Stimulates Policy Changes For Care Of Iraq, Afghanistan Veterans

AcademyHealth has recognized research that improves access to behavioral health care for returning U.S. service members with the 2011 Health Services Research (HSR) Impact Award. The research project, “The Invisible Wounds of War,” is the first and only large-scale, nongovernmental assessment of the psychological needs of Iraq and Afghanistan veterans, and led to policy action by members of Congress, the Department of Defense, and the VA, and other stakeholders.

“The policy changes resulting from this study show how powerful and essential research is to improving care for Americans,” said Lisa Simpson, president and CEO of AcademyHealth. “With this award, we recognize the effective dissemination and translation strategies that gave policymakers the evidence needed to inform their decisions.”

The study, conducted by the RAND Corporation, analyzed the mental health and cognitive needs of veterans. The investigators found that nearly 20 percent of U.S. service members returning from Iraq or Afghanistan showed symptoms of post-traumatic stress disorder, depression, and/or traumatic brain injury. Roughly half of those needing treatment had sought it, but only slightly more than half who received treatment got minimally adequate care. As a result, RAND researchers disseminated their findings to a broad group of stakeholders, and recommended improvements to ensure better access to and delivery of evidence-based mental health care.

The analysis drew the attention of policymakers and the public to the large numbers of returning Iraq and Afghanistan veterans who developed behavioral health care needs following deployment. Study findings stimulated wide-reaching policy change. Secretary of Defense Robert Gates finalized modifications to the Department of Defense security clearance application to diminish potential stigma associated with psychological care. Subsequently, the chairman of the Joint Chiefs of Staff called for mandatory screening for post-traumatic stress for all returning military personnel. The principal user of this research, the U.S. Congress, cited the study as essential in its work.

Accepting the award on behalf of the RAND “Invisible Wounds of War” project is Terri Tanielian, M.A., senior social research analyst and co-director of the RAND Center for Military Health Policy Research.

Elyse Phelps

Cannabis does not induce schizophrenia, Dutch scientists say

A group of Dutch scientists say that there is no proof that cannabis induces schizophrenia. These findings will be embarrassing for the Dutch government, which has been bearing down on Marijuana Coffee Shops saying the drug induces schizophrenia.

You can read about this study in the journal Psychiatry.

The scientists say in the journal that after reviewing currently available data there is justifiable reason for closing down coffee shops in The Netherlands.

The scientists say the drug only seems to affect people who are genetically predisposed to getting schizophrenia (meaning they will get it anyway). As schizophrenia manifests itself during adolescence, and many people start taking cannabis during adolescence – it is just coincidence that some people develop the mental illness soon after they start taking the drug.

The authors of the report wrote “It is therefore advisable that youngsters with a family history of schizophrenia and patients with a schizophrenic disorder be discouraged from using cannabis.”

Next year all coffee shops will be subjected to a smoking ban in The Netherlands. The sale of alcohol in Dutch coffee shops is being banned this year.

Badger Cull Supported By Science, Say Vets, UK

Veterinary associations have strongly welcomed the announcement by Defra that it is strongly minded to include a controlled cull of badgers as a key component of the bovine tuberculosis (TB) eradication plans for England.

The British Veterinary Association (BVA) and its specialist cattle division the British Cattle Veterinary Association (BCVA) have long supported the need to control TB in both cattle and wildlife, including the need for a targeted, humane cull of badgers in specific parts of the country.

Following a comprehensive consultation exercise (which closed in December 2010), Defra has today announced:

– A 9-week consultation on plans to license groups of farmers and landowners to carry out controlled culls of badgers in specific areas

– Ongoing cattle measures and planned measures, including reducing compensation where TB tests are overdue and removing some exemptions to pre-movement testing

- ВЈ20 million investment over the next five years to develop effective cattle and oral badger vaccines

The BVA and BCVA jointly responded to Defra’s 2010 consultation to say that the available science supported the case for a badger cull, alongside the need for stricter cattle control measures, in those areas where badgers are regarded as a significant contributor to the persistent presence of TB. The response also emphasised strongly that any cull of badgers had to be done in a humane and effective manner.

Today’s announcement reveals that Defra has listened closely to the veterinary associations’ concerns. Through the consultation response the BVA and BCVA raised the important issue of the efficacy of an industry-led cull using controlled shooting (as opposed to cage trapping and shooting) and stated firmly that any cull must be monitored for humaneness. Both of these issues have been considered in depth by Defra and appear to have been addressed in the plans.

The BVA and BCVA will be looking closely at the detail of the guidance issued today and will be responding to the consultation.

Commenting, Harvey Locke, President of the BVA, said:

“The BVA and BCVA have long argued for a targeted, humane badger cull to be used alongside stricter cattle controls. We believe that failure to tackle wildlife sources of TB infection has prolonged the presence and enhanced the spread of infection in all affected species populations.

“We recognise that this is a very emotive and difficult decision but we believe that the science supports this policy and we support Defra’s commitment to tackling this devastating disease.

“We are particularly pleased that this announcement has not been delayed until after the summer recess, which demonstrates the seriousness of the need to tackle TB.”

vJohn Fishwick, President of BCVA, added:

“We welcome today’s announcement which indicates that a humane and carefully targeted cull of badgers can contribute to the control of this dreadful disease.

“We are particularly pleased that the veterinary profession’s concerns that any cull must be humane and well monitored appear to have been listened to and we will now study the proposals in detail.

“An industry-led cull will be an enormous undertaking for everyone involved and it is vital that we get the detail right from the outset; for the sake of cattle, wildlife and industry.”


British Veterinary Association

New study seeks out evidence of stem cells in the heart

If you’ve ever used a loofah in the shower, you’ve stirred up some stem cells. As the outer layer of skin sloughs off, stem cells in the dermis rush to repair and replace those buffed away.

Now imagine a tiny loofah that works in much the same way inside the corridors of the human heart. As it scrubs, it alerts heart stem cells to rush to the site of dying cells to begin renewal and repair of cardiomyocytes – cells that pump blood through the heart.

While a heart loofah may remain the stuff of medical fantasy, Steven Houser, Ph.D., Director of Cardiovascular Research Center at Temple University School of Medicine, is sold on the idea that the heart – like the skin – contains its own stem cells: cells that are self-renewing and can be differentiated into different types of heart tissue. It’s a controversial subject in cardiovascular circles, but for Houser, who spent thirty years studying the molecular biology of heart cells, the stakes are worth it when it comes to combating congestive heart failure (CHF).

Although stem cells have been found in many other organs in the body, including the brain, many researchers remain unconvinced that the heart contains stem cells. Houser respectfully disagrees. Abandoning his prior cell research, he has joined forces with one of the foremost investigators in cardiac stem cells, Pierro Anversa, M.D., professor of medicine and Director of the Cardiovascular Institute at New York Medical College. Anversa, who has been on the forefront of stem cell research for the past five years, has suggested that heart cells undergo an ongoing turnover fueled by cardiac stem cells. In June of this year, he published a study that actually identified cardiac stem cells in animal models that repaired tissue damaged by a heart attack.

One element that convinced Houser of Anversa’s work was his own research into how the heart reacts under the stress of hypertensive diseases that can lead to congestive heart failure. Early in the disease, the heart muscle mass increases and the chambers stretch in a vain attempt to increase contracting power. While part of the enlargement is due to increased muscle mass, the question of how the chambers grow is less certain.

The traditional view holds that cardiac cells simply grow larger to accommodate the increased need, but Houser and Anversa developed a different theory – that spurred by the cardiac stem cells, cardiomyocytes actually increase in number in their response to the heart’s traumatic condition.

To test this theory, Houser, with the help of Anversa, has received a new NIH grant to study if there are autologous stem cells in the heart. The two researchers have arrived at a deceptively simple idea. After inducing hypertension in an animal model to produce a distressed heart they will study the heart tissue and count cells, first in the normal heart and then in a heart that must work harder to develop excess pressure. If, according to the scientists’ thesis, there are more cardiomyocytes in the heart as opposed to simply larger cells, they will conclude that stem cells had a hand in an attempt to repair and restore the heart.

“We’ve made a tremendous impact on cardiovascular diseases,” he says. “But what we need to do now is to reverse this disease rather than just slow its progression.”

Although his colleagues may remain skeptical, Houser has committed himself to the stem cell model. Inducing cells to promote repair can answer the question that has haunted his career.

“We don’t know how to fix the broken heart, but stem cells might be a large part of the answer.”

Eryn Jelesiewicz
Temple University

Passive smoking damages IVF success as much as active smoking

It has been known for some time that smoking can affect a woman’s fertility, but Canadian research published (Thursday 26
May) in Europe’s leading reproductive medicine journal Human Reproduction[1] suggests that exposure to side-stream smoking –
smoke given off by a smouldering cigarette[2] – is just as damaging.

In a study of women undergoing IVF or ICSI[3], researchers from McMaster University and Hamilton Health Sciences, in
Hamilton, Ontario, examined the quality of embryos and the implantation and pregnancy rates of 225 women who were grouped
according to whether they were non-smokers, smokers or side-stream smokers[4] – side-stream smokers being defined as women
who lived with a partner who regularly smoked.

They found no difference in the quality of the embryos from the three groups. But, there was a striking difference in
implantation and pregnancy rates between the non-smoking group and the smokers and side-stream smokers.

The risk of side-stream smoking on reproductive health was unknown until now, but the evidence from this study of the
damaging effect is so clear that the researchers are now warning all their patients of the potential hazards, according to
lead researcher Michael Neal, PhD candidate at McMaster University and Hamilton Health Sciences.

“We found that embryo quality and fertilisation rates were similar in the three groups, but there was a significant
difference in the pregnancy rates per embryo transfer with the non-smokers achieving around 48%, the smokers around 19% and
the side-stream smokers 20%. When it came to implantation rates, which we calculated as the number of foetal sacs with a
positive heartbeat divided by the total number of embryos transferred, we found that while non-smokers achieved a 25%
implantation rate, both smokers and side-stream smokers managed only around 12%.”

Senior researcher Professor Warren Foster, director of IVF and reproductive biology at the Centre for Reproductive Care at
McMaster University’s Department of Obstetrics and Gynecology, said that this was a retrospective study relying on
self-reported smoking habits and should be confirmed by a prospective study with objective measures of cigarette smoke
exposure, which would also test for possible dose-related effects, though none were identified in this study.

“Although we do need a prospective confirmatory study, the findings from our study already warrant a warning to women to
reduce or, if possible, prevent exposure to cigarette smoking, especially if they are trying to conceive,” he said.

The researchers plan to undertake a prospective study if funding for a research proposal under review is forthcoming. They
are also looking for possible collaborators.

Meanwhile, they are trying to establish why there was no difference in the appearance and development of the pre-implantation
embryos from all three groups, yet a significant decrease in the ability of the embryos from smokers and side-stream smokers
to implant and/or maintain a pregnancy.

“This was the most striking finding from our study,” said Mr Neal.

It was possible, he said, that cigarette smoke compromised the competence of the egg, perhaps by disrupting the proliferation
of the granulosa cells in the egg follicle and their production of the oestrogen-producing enzyme aromatase, but that the
lethal results were not apparent until later in embryonic development. However, this was still only speculation.

It was clear, the researchers concluded, that it is essential to study the effects of cigarette smoke on the female gamete.
The damaging effects on sperm are well documented as sperm are more accessible and easier to study. Studying the female
gamete, on the other hand, is much more difficult since human ooctyes are precious.

“Our study is unique in looking at the female, who is just as vulnerable, if not more vulnerable to environmental toxicants
such as cigarette smoke,” said Mr Neal. “An isolated follicle culture system that we have developed is now allowing us to
investigate the effects of smoking contaminants on follicle growth in vitro and this will give us the chance to address some
of the questions that would otherwise be difficult to answer.”

[1] Side-stream smoking is equally as damaging as mainstream smoking on IVF outcomes. Human Reproduction.

[2] Side-stream smoking is strictly defined as smoke that is emitted from the smouldering end of the cigarette and contains
the most toxic constituents. Passive smoke includes side-stream smoke along with smoke exhaled by the smoker.

[3] IVF = in vitro fertilisation. ICSI = intracytoplasmic sperm injection: process by which an egg is fertilised by injecting
a single sperm into the egg.

[4] The 39 smokers in the study smoked a mean of 11 cigarettes a day. Their partners smoked a mean of 10.7 a day (8 were
non-smokers). Of the 40 side-stream smokers, the male partners smoked a mean of 10.8 cigarettes a day. 146 women were
non-smokers (i.e. neither they nor their partners smoked).

1 PDF version of this press release and full embargoed text of the paper with complete results can be found from 09:00hrs
London time Tuesday 24 May at: oup/eshre/press-release/may052.pdf or is available from Margaret Willson.

2 Human Reproduction is a monthly journal of the European Society of Human Reproduction and Embryology (ESHRE). Dr Helen
Beard, Managing Editor. Tel: +44 (0) 1954 212404 Email: beardhhumanreproduction

Please acknowledge Human Reproduction as a source.

3 ESHRE’s website is: eshre

4 Abstracts of other papers in ESHRE’s three journals: Human Reproduction, Molecular Human Reproduction & Human Reproduction
Update can be accessed post embargo from www3.oup/eshre Full text of papers available on request from Margaret Willson.

European Society for Human Reproduction and Embryology

Hypertension: Europe Reins In The Smoking Habit

The Global Alliance for Chronic Diseases has announced its intention to release a Request for Applications (RFA) on Implementation Research on Hypertension in Low and Middle Income Countries

A study led by the Smoking Control Unit of the Catalan Institute of Oncology (ICO) has confirmed that the anti-tobacco laws in Europe have a direct effect on the reduction in consumption and passive exposure to smoke. This conclusion was reached by relating the Tobacco Eurobarometer and the Tobacco Control Scale (TCS).

A new study, published in the magazine Plos One, has confirmed the hypothesis that the greater the restrictions, the lower the consumption and passive exposure to smoke. The study was carried out in the 27 countries of the EU and relates the Eurobarometer survey on tobacco and the Tobacco Control Scale (which takes into account the main measures taken in order to control smoking at international level).

“The countries with the highest score in the TCS apply active control policies and the consumption of tobacco and the proportion of the population exposed to smoke, both at home and in the work place, is more reduced”, explained Esteve FernГЎndez MuГ±oz, co-author of the study and the Head of the Tobacco Control Unit of the ICO to SINC.

In countries such as the United Kingdom, Ireland, Malta and Sweden, which score higher on the TCS (that is to say, they adopt stricter controls on smoking), the consumption is “relatively low” -28.8% lower-, as is exposure to smoke -13.8% lower in the home and 23.4% lower in the work place -.

However in the Czech Republic, Germany, Luxembourg, Greece and Austria, where there are fewer control measures, smoking is “relatively high” – more than 30%-, as well as the exposure to smoke – between 15% and 30% in the home and between 15% and 36% in the work place -.

Progressively more measures in Spain

FernГЎndez MuГ±oz pointed out that the reform of Law 28/2005 on health care measures concerning smoking, which came into force yesterday, “is an example of the very important progress in the control of smoking and means the abolition of the ‘Spanish model’ of supposed tolerance”.

Although Spain scores high on the TCS, there are some aspects in which its score is low, such as the price of tobacco. He assured us that, “It is one of the countries in Europe with the cheapest prices”.

“It has been demonstrated that increasing the price of tobacco is the most effective measure for controlling smoking (30 points out of 100 on the TCS scale) as compared with other action, such as, treatment to quit smoking (10 points on the TCS)”, ponnted out the researcher.

The experts forecast that these measures will reduce the incidence of cardiovascular disease in the short and medium-term, as well as the incidence of cancer, mainly lung cancer, in the long-term. In Spain, passive exposure to smoke leads to between 1,200 and 3,200 deaths per year due to lung cancer and heart attacks.


Jose M. MartГ­nez SГЎnchez, Esteve FernГЎndez, Marcela Fu, Silvano Gallus, Cristina MartГ­nez, Xisca Sureda, Carlo La Vecchia, Luke Clancy. “Smoking Behaviour, Involuntary Smoking, Attitudes towards Smoke-Free Legislations, and Tobacco Control Activities in the European Union”. Plos One 5 (11): e13881, noviembre 2010.


FECYT – Spanish Foundation for Science and Technology

Need For Biopsies May Be Reduced By Biomarkers

Data presented at this week’s 28th Annual Meeting and Scientific Sessions of the International Society for Heart and Lung Transplantation (ISHLT) suggest the potential of a significant impact of using biomarkers to reduce the need for biopsies and personalize transplant patient care. Non-invasive testing using gene-based blood or urine samples called biomarkers could offer transplant patients personalized care and medication and may replace the need for costly, invasive biopsy procedures that can be risky for patients. The meeting will run through Saturday at the Boston Marriott Copley Place and Hynes Convention Center.

Personalized care is an integrative process of tailoring care to an individual patient’s characteristics or preferences, based on each individual’s unique biology, behavior and environment. At this year’s meeting, researchers are presenting data from gene and protein based blood testing that may be helpful for reducing immunosuppression. Related data suggests gene analysis may allow for prediction of future occurrence of cardiac allograft rejection and its diagnosis.


Today’s plenary lectures provide current perspectives on biomarkers in transplantation. In Biomarkers: What Are They? How Might They Aid in Care of Allograft Recipients and Other Patients? Christopher J. O’Donnell, MD, MPH, from NIH National Heart, Lung and Blood Institute/Framingham Heart Study, Framingham, MA, will present data pertaining to personalized care, its benefits and future impact on heart and lung patients.

Following, Dr. Christoph Borchers, Director of the Genome Canada Proteomics Platform at the University of Victoria, British Columbia, will provide a look at the emerging strategies for plasma protein analysis in New Tools, Technologies and Results for Probing Proteomic Biomarkers in Plasma of Transplant Patients.

Finally, Dr. Ralph Weissleder from Massachusetts General Hospital/Harvard will discuss Imaging Biomarkers: New Horizons and Opportunities in Transplantation, and will share the latest information on imaging biomarkers and how advanced imaging techniques may soon help in the management of transplant patients. Three related biomarker abstracts are also slated for presentation during the session.

“In recent years, there has been an intensive focus on enhancing our ability to provide the most particular predictive, diagnostic, prognostic and therapeutic guidance for patients. This intent has been enabled by unbiased and targeted examination of genotypes and haplotypes that may convey risk or protection against certain disease processes like immune rejection, as well as by defining the molecular signatures of a disease process like rejection by measuring mRNA, proteins or metabolites in the blood or urine. Distillation of such data, along with clinical features, is intended to improve care, reduce costs, and make patients lives more enjoyable,” said Bruce McManus, MD, PhD, University of British Columbia, one of the Co-Chairs for the biomarkers plenary session.

Until recently, heart muscle biopsy was the only method available to rule out heart transplant rejection and guide treatment with anti-rejection, or immunosuppressive, therapy. Aside from the invasive and painful nature of the procedure, a biopsy is only able to detect rejection after damage has already occurred to the heart tissue. Similar dilemmas exist in the monitoring of lung transplant recipients.

Alternatively, non-invasive molecular testing of a routine blood sample allows analysis of gene expression in white blood cells, proteins in the plasma, and metabolites in blood and urine. The latter biomarkers provide information on the immune, inflammatory and injury status of the transplanted heart before tissue damage occurs. The new and original information on biomarkers and personalized care in lectures given at ISHLT will offer a deeper knowledge of this innovative direction that is revolutionizing health care. The discussion will also raise awareness of alternatives to biopsy procedures that are on the horizon.



The International Society for Heart and Lung Transplantation (ISHLT) is a not-for-profit organization dedicated to the advancement of the science and treatment of end-stage heart and lung diseases. Created in 1981, the society now includes more than 3,000 members from more than 45 countries, representing a variety of disciplines involved in the management and treatment of end-stage heart and lung disease.

ISHLT maintains two vital databases. The International Heart and Lung Transplant Registry is a one-of-a-kind registry that has been collecting data since 1983 from 223 hospitals from 18 countries. The ISHLT Mechanical Circulatory Device (MCSD) database has been collecting data since 2002 with the aim of identifying patient populations who may benefit from MCSD implantation; generating predictive models for outcomes; and assessing the mechanical and biological reliability of current and future devices. In fall 2006, ISHLT released the first international guidelines for heart failure patient management. For more information, visit ishlt/.

Source: Lauren Mason

International Society for Heart and Lung Transplantation

International Eppendorf-Science Award Won By BCM Neuroscientist

Memories turned on and off with a flick of a switch – the idea is the basis for the award winning research of Dr. Mauro Costa-Mattioli, assistant professor of neuroscience at Baylor College of Medicine in Houston.

Costa-Mattioli is being honored with the prestigious Eppendorf and Science Prize for Neurobiology for his work identifying a single molecule that when modified can affect memory.

His findings are outlined in his winning essay titled “Switching memories ON and OFF” that can be found in the current publication of Science.

“This is certainly one of the first steps to one day being able to help those suffering from age-related memory loss or even the more devastating memory loss caused by Alzheimer’s disease,” Costa-Mattioli said. “It is imperative to understand how the brain’s basic molecular processes function to generate corresponding insights in cognitive disorders.”

It is well known that making long-lasting memories is dependent on the ability of brain cells to create new proteins. Costa-Mattioli found that by reducing activity of a key protein called translation initiation factor 2 alpha, eiF2О±, the expression of genes and proteins needed for the formation of a long-lasting memory is increased. Costa-Mattioli and colleagues genetically reduced eiF2О± activity in mice. The test mice were then tested in a variety of behavioral paradigms. For instance, to study spatial memory, which underlie our ability to remember people, events and a particular environment; mice were trained in the Morris Water. In this task, mice swimming in a pool of opaque water search for a submerged platform. The mice used visual cues that are placed on the walls of the room to remember the location of the platform.

The mice with reduced activity of eiF2О± were able to find the platform significantly faster than the average mice.

“Unlike normal mice, mice with decreased eIF2О± activity knew exactly where the platform was located and swam straight towards it,” he said.

Researchers also looked at the strength of the connections between neurons, called synapse, what is believed to be a “cellular model” to study learning and memory. Usually weak stimulation elicits a short lasting response or a transient enhancement of such synaptic connections, while strong or repeated activity triggers a long-lasting persistent enhancement of the strength of synaptic connections. Strikingly, in the test mice weak stimulation induced longer lasting strengthening of the synaptic connections between neurons, indicating that a short exposure to a given experience created long term memories.

“It usually takes several attempts to memorize a passage of a textbook, practice makes it perfect” Costa-Mattioli said. “A human equivalent of these mice would get the information if he reads it just once.”

An important aspect of Costa-Mattioli’s studies is that treatment of mice with a drug which increases the activity of eIF2О± block the formation of long-lasting changes and long-term memory.

“The ability to erase specific memories would be crucial in the treatment of patients suffering from traumatic memories such as post-traumantic stress disorder,” he said.

Dr. Michael Friedlander, chair of the department of neuroscience at BCM and the director of Neuroscience Initiatives at the College, said, “We are extremely fortunate to have recruited Dr. Costa-Mattioli to BCM. His recent discoveries on the role of specific protein synthesis in the conversion of short-term to long-term memories have dramatically re-awakened the world neuroscience community’s interest in this critical molecular process. These new insights will drive experimental innovation in basic neurobiology of memory and diseases such as Alzheimer’s that rob us of this most precious function.”

Costa-Mattioli’s recruitment to Houston was supported by the Cynthia and George Mitchell Foundation. He joins a growing memory research community in the Department of Neuroscience and in the new Mitchell Center for Brain Aging and Dementia and the Center for Memory and Learning at BCM.

Costa-Mattioli’s studies were started at McGill University in Canada in the laboratory of Nahum Sonenberg.


The Eppendorf and Science Prize for Neurobiology acknowledges the role of neurobiology in advancing our understanding of the functioning of the brain and the nervous system. It is awarded annually for the most outstanding neurobiological research by a young scientist.

The award ceremony will be held in Washington, D.C. on Nov. 16.

The embargo lifts the essay can be found at sciencemag/.

For more information on basic science research at Baylor College of Medicine, please go to

Source: Graciela Gutierrez

Baylor College of Medicine