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QUMAS, the leading provider of Compliance Solutions to highly regulated industries, announced the launch of the QUMAS Biotechnology Package, a complete webbased electronic document management system (eDMS) for Biotechnology companies preparing for regulatory submission. This affordable package has been created specifically for small biotech companies, in order to give them access to QUMAS DocCompliance, the leading eDMS used by tier one companies globally. Growing biotechs can now afford a complete eDMS for document control, which is preconfigured with industry practices, and can be validated and live within 30 days.

“We are delighted to be able to provide an affordable offering to smaller companies who can now leverage the same solutions as the leaders in their space in a cost effective and highly efficient package,” said Ken Hayward, CTO of QUMAS. “They can also leverage our expertise, as configured in the system, to ensure that they operate a compliant organization from the outset, making them more viable in a regulatory context and more attractive to investors and partners.”

The QUMAS Biotechnology package is

Easy and fast to implement go live within 30 days
Preconfigured with industry standards for regulatory compliance
Best of breed document management, which is in used in over 250 facilities globally
Extendable and scalable, as the company, the requirements and the infrastructures grow
Easy to use with fast track training built in
Compatible with all existing documents and processes
A cost effective world class solution at an industry leading cost

QUMAS is launching the Biotechnology Package in the EU on September 15, at the DMS Expo in Cologne. QUMAS is launching the Biotechnology Package in the US on September 16, at a Compliance Breakfast Seminar in the Vertex Pharmaceuticals facility in Cambridge, MA. Also speaking at this event will be clients from Vertex Pharmaceuticals and Millennium Pharmaceuticals, along with QUMAS Regulatory experts.

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The Innovative Medicines Initiative (IMI), the publicprivate partnership between the European Commission and the European pharmaceutical industry, represented by EFPIA, today made its first major announcement of the success of the collaboration. IMI also announced the topics of research of its second call for proposals. With these topics, IMI aims to accelerate the discovery and development of new medicines in the field of cancer, inflammatory and infectious disease. The funding available for the 2nd call will be €156.3 million, with €76.8 M provided by the European Commission and €79.5 M expected to be provided in kind from EFPIA member companies. IMI also introduced also its newlyappointed Executive Director, Michel Goldman, who will officially take up his post on 16 September.

The EU Commissioner for Science and Research Janez PotoДЌnik underlined the achievements and major advances of the initiative IMI is our response to the need of improving Europes attractiveness for pharmaceutical R&D and to ensure that results from fundamental research can be rapidly translated into new innovative treatments. We should see results from this exciting new research mechanism very soon and hereby that new innovative medicines should reach European patients faster.”

Addressing the media at the event, Arthur J. Higgins, CEO of Bayer HealthCare and President of EFPIA, praised the collaboration between the industry and Commission “The IMI is a clear statement that Europe intends to be at the forefront of biopharmaceutical innovation. By accelerating and optimizing R&D processes we are trying to remove bottlenecks in the drug development process. For this reason, we have already invested € 246 million including € 136 million from industry in the successful proposals to date. The greatest success of this initiative has been in bringing together normally competing pharmaceutical companies with academic stakeholders in an unparalleled effort to accelerate the discovery of innovative medicines.”

The newlyappointed Executive Director, Professor Michel Goldman, said “I am very pleased to be joining IMI at such an exciting moment in its development. On the basis of my previous experience in publicprivate partnerships, my first priority will be to strengthen the bridges between academia and industry in the interest of patients”.

Michel Goldmans appointment as IMIs new Executive Director is an important step towards IMIs complete autonomy from the European Commission and EFPIA.

The new research topics have been approved by the IMI Board, after extensive consultation between various stakeholders; including the IMI scientific committee, Member states representatives, the European commission and pharmaceutical companies that are members of EFPIA. All of which are committed to collaborate with public and private organization to address these issues more efficiently. IMIs second call for proposals should be launched on 30 October 2009.

Background

Launched in 2007, IMI is publicprivate partnership aiming to support more efficient discovery and development of better medicines for patients by removing research bottlenecks in the current drug development process.

The total IMI budget for the period 20082017 is €2 billion (1 billion from the European Community and 1 billion from the industry).

The 1st call of proposals of IMI was launched in April 2008. 134 proposals were submitted of which 15 have been selected to receive € 246 million.

About Michel Goldman

Michel Goldman is professor of immunology at the faculty of medicine of the Université Libre de Bruxelles (ULB) in Belgium. His achievements in the fields of immunemediated disorders and immunebased biotherapies have resulted in more than 380 articles in peerreviewed journals. In 2000 he received the Joseph Maisin Prize, a major award for clinical sciences delivered by the Belgian Fund for Scientific Research. He was recognized as ISI Highly Cited Scientist in 2006 by the Thomson Institute for Scientific Information

List of the 9 topics of IMIs 2nd call for proposals

1. Imaging biomarkers for anticancer drug development.
2. New tools for target validation to improve drug efficacy (oncology).
3. Molecular biomarkers accelerating cancer therapy development and refining patient care.
4. Identification and development of rapid point of care diagnostic tests for bacterial diagnosis to facilitate conduct of clinical trials and clinical practice.
5. Understanding aberrant adaptive immunity mechanisms.
6. Translational research in chronic immunemediated disease bridging between animal models and humans.
7. Drug/disease modelling library & framework.
8. Open pharmacological space.
9. Electronic Health Records (EHR).

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Antisocial and aggressive behaviours represent a widespread and expensive social problem. Recent research has convincingly shown that there is a strong interaction between genetic inheritance and environment for development of personality and behaviour. It appears to be common knowledge that childhood maltreatment often causes psychiatric problems (e.g. depression or anxiety) or behavioural problems (e.g. aggression or antisocial behaviour) later in life. The risk for such a development is, however, different between individuals and can to a large extent be explained by genetic factors. The identification of neural mechanisms underlying human personality and temperament seems to be promising due to their considerable importance as highly heritable risk mediators for aggressive behaviour, criminal activity, as well as somatic and psychiatric disorders (Buckholtz et al., 2008; Buckholtz & MeyerLindenberg, 2008; Nilsson et al., 2006).

MAOs key molecules for personality and behaviour

Monoamine oxidases (MAOs) are two enzymes (MAOA and MAOB) which inactivate the so called monoamine transmitter substances serotonin, noradrenalin and dopamine. The brain systems which utilise those transmitters are of great importance for the finetuning of personality traits, as well as statedependent features such as mood, appetite, attention, etc. MAOs are present in almost all cells in the body, however, naturally, it is the activities of MAOs in the brain that are of major interest in relation to personality and behaviour.

In association with a complete lack of MAOA, as in mice in which the MAOA gene has been knocked out, and in a Dutch family with a dysfunction of this gene, aggressiveness has been reported (Brunner, 1996). In the Dutch family aggressiveness was also combined with arson and cases of rape indicating a lack of impulse control. Extensive search for more families with this abnormality has, however, been negative.

Measurements of MAO activities in brain tissue, either postmortem or using various imaging techniques, are, however, tedious and not suitable for larger samples of individuals. Furthermore, unless combined with functional tasks, as in functional Magnetic Resonance Imaging (fMRI), findings in relation to behaviour have usually not been particularly rewarding. This could possibly be explained by the fact that the majority of the enzyme is localised in glial cells, and that the population of enzyme molecules of immediate interest for monoamine inactivation is difficult to measure.

One of the MAO enzymes the MAOB is localised in blood platelets and is therefore accessible for activity measurements in larger samples of individuals. MAOB enzyme activity is highly inheritable, as shown in twin studies, and is stable in the individual during lifetime. Interestingly, decades ago low platelet MAOB activity was shown to be associated with personality traits such as impulsiveness, monotony avoidance and aggressiveness, and, as a consequence, vulnerability for the type of alcoholism characterised by strong heritability and antisocial behaviour (type 2). While low platelet MAOB activity thus involves a risk for the individual, it also might be associated, at the other end of the spectrum, with positive outcomes of impulsiveness and ´sensation seeking´ such as creativity and success.

Antisocial behaviour biological factors

In some nonclinical series of individuals the association with aggressiveness or antisocial behaviour, however, becomes significant only if the interaction with the environment is considered, particularly in girls/females. Personality is, naturally, a result of the influence of a large number of genes, all of which result in the formation of their respective proteins, e.g. enzymes such as the MAOs.

Another protein of importance for the elimination of the neurotransmitter serotonin is the serotonin reuptake pump (5HTT), which is the target for the currently most commonly used antidepressant drugs, the selective serotonin reuptake inhibitors (SSRIs). The gene producing this protein exists in variants among different individuals. Those variants are usually referred to as the short and the long variant, shown to be of importance for the risk of anxiety or depression (Harro et al., 2009). Not surprisingly, the association between platelet MAOB activity and personality gets stronger if other independent factors affecting personality are eliminated. Thus, if only individuals carrying the short variant of the 5HTT gene were investigated, the association between platelet MAOB activity and behaviour became considerably strengthened, both with regard to impulsiveness in a large series of adolescents, and, in a small series of boys, with dimensional scores for ADHD.

The gene producing MAOB also exists in variants. One variant of the gene is weakly associated with platelet MAOB activity, but strongly interacts with poor psychosocial environment to predict antisocial behaviour, particularly in girls. An interesting question that remains to be answered is why the association between the MAOB gene variant and antisocial behaviour was found to be considerably stronger than with the activity of platelet MAOB.

A wellstudied variant in the MAOA gene is also associated with antisocial behaviour. Usually this association has been found only in individuals in a poor psychosocial environment, where the gene variant associated with low activity (i.e. a low rate of synthesis of MAOA enzyme) has been strongly linked with antisocial behaviour in males (Nilsson et al., 2007). Recent studies, however, repeatedly also found an association in girls/females, in some series of such a magnitude that MAOA genotype alone independently of environment showed a significant association. Remarkably, all series showed that, in contrast to the case in males, the highactivity variant is the one associated with vulnerability for antisocial behaviour in females (Nilsson et al., 2008) (see figure 1). This is in line with a marked sex difference between the gene variants with regard to changes in blood flow in specific brain regions as a response to emotional stimuli, using fMRI, which has been shown by the group of MeyerLindenberg.

Genetic influences on impulsiveness and ´sensation seeking´

Our findings raise a number of questions How are stable factors such as personality and temporal factors and current mood or appetite related to each other if brain serotonin activity is involved in both?

How can platelet MAOB activity be associated with a stable factor such as impulsiveness? The view on the first question is that the personality, which is a lifelong characteristic of the individual, is mainly a consequence of the size or capacity of the brain monoamine systems, while statedependent factors such as mood are dependent on the current activity, large or small, in the system. It is obvious that an impulsive, ´sensationseeking´ person, as well as a more introvert and monotonyresistant individual can be in a high or low mood, depending on the current situation.

Probably events during life development explain the associations between MAO gene variants and personality. During foetal development, high levels of serotonin have been shown to be an effective inhibitor of the growth of the serotonin system. Hence, gene variants inferring a low rate of inactivation of serotonin, especially during foetal life, will lead to a small or lowcapacity brain serotonin system in the adult. Both experiments with animals, using serotonin specific neurotoxins, and studies on humans, e.g. by measuring levels of degradation products of serotonin in the cerebrospinal fluid, have shown that a reduced or low capacity of the brain serotonin system is linked to a personality characterised by impulsiveness and ´sensation seeking´. High ´sensation seeking´ in turn has been linked to increased risk for negative behavioural outcomes such as drug abuse etc. (Joseph et al., 2009).

With regard to the association between platelet MAOB and personality, experimental results make us hypothesise that part of the explanation is to be found in the regulation of the activity of genes. Regardless of individual variants in the structure of genes, their activity is also regulated by activators or inhibitors (transcription factors), which bind to a specific part, the regulatory or promoter part, of the gene. There is reason to believe that the gene producing MAOB and a number of genes producing proteins that constitute important parts of the brain monoamine systems are regulated by the same transcription factors.

One candidate for being such a common transcription factor is AP2ß (Nilsson et al., 2009). A low transcriptional activation of both the gene responsible for the production of platelet MAOB and for a number of genes responsible for building up brain monoamine pathways could in this way explain how a low activity (or level) of platelet MAOB protein is mirroring a weak or low capacity of the monoamine systems in the brain. These would in turn constitute the biological basis for personality traits such as impulsiveness and ´sensation seeking´.

Clinical implications Our geneenvironment interaction findings, as well as those of others in this field, show a way of understanding biological mechanisms underlying the individuals degree of dependence on the environment for the development of e.g. substance abuse, antisocial behaviour, suicidal behaviour, etc.

Thus, individuals with one set of MAO gene variants seem to be virtually independent of environment for the risk of e.g. antisocial behaviour, and in this way could explain resilience towards an unfavourable environment, while those with another set of MAO gene variants are highly dependent on psychosocial environment for behaviour.

Another clinically important result is the finding of dramatic sex differences with regard to the direction of behaviour related to the interaction between MAO gene variants and environment. Conclusion

Apart from psychosocial influences, biological factors have a major influence on personality traits and behaviour.

The aggregation of certain risk factors in the same individual has been shown to contribute to the development of antisocial behaviour. Research findings suggest that both the molecular and the psychosocial mechanisms underlying emotional response and antisocial behaviour may differ between males and females.

Based on geneenvironment interactions, the brain monoamine systems play a crucial role in shaping personality traits and conduct disorder. The MAO genes appear to be the first genes strongly linked with either antisocial behaviour or conduct disorder.

Individuals with one set of MAO gene variants seem to be virtually independent of environment for the risk of e.g. antisocial behaviour, and in this way could explain resilience towards an unfavourable environment. In contrast, those with another set of MAO gene variants are highly dependent on psychosocial environment and have considerable vulnerability for antisocial behaviour.

References Brunner HG. MAOA deficiency and abnormal behaviour perspectives on an association. Ciba Found Symp 1996;194155164

Buckholtz JW, MeyerLindenberg A. MAOA and the neurogenetic architecture of human aggression. Trends Neurosci 2008;31(3)120129

Harro J, Merenäkk L, Nordquist N, et al. Personality and the serotonin transporter gene Associations in a longitudinal populationbased study. Biol Psychol 2009;81(1)913

Joseph JE, Liu X, Jiang Y, et al. Neural correlates of emotional reactivity in sensation seeking. Psychol Sci 2009;20(2)215223

Nilsson KW, Sjöberg RL, Damberg M, et al. Role of monoamine oxidase A genotype and psychosocial factors in male adolescent criminal activity. Biol Psychiatry 2006;59(2)121127

Nilsson KW, Sjöberg RL, Wargelius HL, et al. The monoamine oxidase (MAOA) gene, family function and maltreatment as predictors of destructive behaviour during male adolescent alcohol consumption. Addiction 2007;102(3)389398

Nilsson KW, Wargelius HL, Sjöberg RL, et al. The MAOA gene, platelet MAOBactivity and psychosocial environment in adolescent female alcoholrelated problem behaviour. Drug Alcohol Depend 2008;93(12)5162

Nilsson KW, Sjöberg RL, Leppert J, et al. Transcription factor AP2 beta genotype and psychosocial adversity in relation to adolescent depressive symptomatology. J Neural Transm 2009;116(3)36370 Source
Sonja Mak

Scientists in Germany are reporting a major improvement in their potential new treatment for facial wrinkles that could emerge as an alternative to Botox and cosmetic surgery. The noninvasive technique combines highintensity light from lightemitting diodes (LEDs) and a lotion made of green tea extract. It works ten times faster than a similar antiwrinkle treatment that uses LEDs alone, the researchers say. Their study is scheduled for the Oct. 7 issue of ACS Crystal Growth & Design, a bimonthly journal.

Andrei P. Sommer and Dan Zhu point out that researchers have used lighttherapy, or phototherapy, for more than 40 years to help heal wounds. Recently the scientists showed that use of highintensity LEDs, similar to those used in automotive tail lights and computers, could help reduce skin wrinkles when applied daily for several months. But exposure to intense LED light is also involved in generating high levels of reactive oxygen species as byproducts that can potentially damage cells. To combat that effect, the researchers combined the LED with a potent antioxidant in green tea extract called epigallocatechin gallate.

They applied a daily combination of LED light and green tea extract to the facial wrinkles of a human volunteer one month. The combination treatment resulted in smoother skin, including “less pronounced wrinkle levels, shorter wrinkle valleys, and juvenile complexion,” the scientists say. The treatment showed promising results in only onetenth of the time it took for LED therapy alone to reduce wrinkles. The study could form the basis of “an effective facial rejuvenation program,” and lead to a new understanding of the effect of reactive oxygen species on cellular aging, they note.

Article
“Facial Rejuvenation in the Triangle of ROS”
pubs.acs.org/stoken/presspac/presspac/full/10.1021/cg900688g

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Michael Woods

Barley, one of the worlds most important crops, ranks third in the United States and fourth worldwide among cereals in area of cultivation and quantity produced. A major animal feed crop, it is also the grain of choice for making malt and beer, and, in some temperate areas, is increasingly being used as a source of biofuel. Barley is considered a healthful food, too, because it can reduce blood glucose levels and lower cholesterol.

To breed improved varieties of barley, scientists must understand its genetic makeup, identify genes that control important traits such as yield, disease resistance, and food and malt quality, and select the best trait combinations they wish to see emerge in new varieties.

Researchers at the University of California, Riverside now will be able to advance their work on sequencing the barley genome (complete genetic blueprint) and breeding new barley varieties thanks to a twoyear $1 million grant they received from the U.S. Department of Agricultures Cooperative State Research, Education, and Extension Service (USDA/CSREES).

The project will build upon resources for physically mapping and sequencing barley genes that the researchers already have developed at UC Riverside from several USDA and National Science Foundation projects they have led.

“New varieties play a critical role in sustaining barley as a crop in the United States,” said Timothy Close, the principal investigator of the grant and a geneticist in the Department of Botany and Plant Sciences. “The longterm goal of our project is to sequence all barley genes and to greatly improve public access to this knowledge.”

Close is joined in the research by Stefano Lonardi, the grants coprincipal investigator and an associate professor of computer science and engineering. Both scientists are members of the USDA/CSREES Barley Coordinated Agricultural Project (BarleyCAP), a community effort of 30 scientists from 19 U.S. institutions focused on identifying molecular markers that will dramatically speed up breeding efforts to improve barley for food, feed and brewing.

After crossing different varieties of barley plants, plant breeders sift through the resulting large population of possible new plants in search of superior varieties with particular desired traits. They then isolate these improved varieties by using “markerassisted selection” or MAS, a sophisticated technology that quickly determines a plants genetic information.

Close explained that MAS is able to greatly speed breeding efforts by utilizing genetic markers chemical flags that indicate a particular genetic trait is in the plant. It is these markers that breeders use to screen large populations of plants from crosses of different varieties. In effect, the markers help breeders locate genes linked to traits the way road signs help a motorist arrive at a destination.

“A plant scientist might mark a combination of genes known to increase resistance to, say, African stem rust,” Close said. “Breeders wanting a barley variety with this particular diseaseresistance trait use marker information to identify this specific combination of genes. This research using MAS is at a jackpot phase with crop plants. We are no longer confined to slower, less directed methods of plant breeding, nor must we base all hope on genetically modified organisms. As long as the naturally occurring germplasm contains the desired traits, and barley usually does, with MAS we can, over just a few years, accomplish improvement in plant varieties that can enormously benefit farmers, markets and consumers.”

Close noted that the tremendous opportunities to improve barley through markerassisted breeding are typical of most of the worlds domesticated species.

“This why people all over the world have become so excited about plant genome research, and it is also why all of the US federal funding agencies have recently shifted their priorities in favor of research on plants of economic and societal importance,” he said.

Close and Lonardi expect to work with large amounts of data that their research will generate. Lonardis lab will analyze the bulk of the data generated at UCR and elsewhere. Gene sequences data also will be generated at the University of Georgia by coprincipal investigator Jeffrey Bennetzen.

“Our proposed sequencing strategy is quite novel,” Lonardi said. “It takes advantage of new combinatorial pooling designs, which allow very large batches of DNA samples to be sequenced at once rather than one DNA sample at a time, combined with high throughput sequencing technology available at UCR. When dealing with large datasets like the one we are expecting, designing time and spaceefficient algorithms is absolutely critical. The analysis of the massive data is likely to create very interesting computational challenges both in the design of novel algorithms and data structures.”

In the project, which began Sept. 1, Close and Lonardi will cosupervise a Ph.D. student in computer science. The grant also will partially support others at UCR Ray Fenton, a staff research associate; Steve Wanamaker, a programmer; and both graduate and undergraduate students in the Close and Lonardi labs.

Close noted that the results of the project will flow immediately into the BarleyCAP network with the assistance of an additional coprincipal investigator, Gary Muehlbaeur at the University of Minnesota, and to a worldwide consortium called the International Barley Genome Sequencing Consortium.

The labs of Muehlbaeur and Bennetzen of the University of Minnesota and the University of Georgia, respectively, will share a total of about 230,000 of the $1 million USDA grant to UCR.

A chance encounter at a campus reception in 2001 brought Close and Lonardi into contact with each other, resulting in a strong research partnership that has brought nearly $3.5 million directly to UCR by way of grants, including the new USDA grant.

Barley, a favorite target of geneticists for decades, is one of the first domesticated cereal grains. In addition to its geographic adaptability, it can withstand cold, drought, alkali, and salinity. The barley genome with 5.3 billion letters of genetic code is one of the largest among cereal crops and nearly twice the size of the human genome.

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Iqbal Pittalwala

NephroGenex, Inc., a privately held drug development company focusing on kidney disease, announced the completion of patient enrollment in its Phase 2b clinical trial (PYR210) studying the safety and efficacy of its lead drug candidate Pyridorin(TM) (pyridoxamine dihydrochloride) in type 2 diabetic patients with overt diabetic nephropathy. Three hundred and seventeen (317) patients have been randomized.

The study is being conducted by the Collaborative Study Group (CSG) at approximately 65 sites in the United States, Australia and Israel. The CSG is a site management organization of nephrologists that has conducted notable landmark studies in diabetic nephropathy in the past, including studies leading to approval of drugs for this indication.

The trial is evaluating two doses of Pyridorin(TM) against placebo in approximately 300 patients for a one year treatment period. Recruited type 2 diabetic patients have elevated serum creatinine levels and significant proteinuria. The estimated study completion date is August 2010.

In previous Phase 2a trials, Pyridorin(TM) therapy demonstrated a significant treatment effect in slowing the progression of diabetic nephropathy as measured by the change in serum creatinine and serum cystatin C over six months, as well as a reduction in urine TGFbeta.

Diabetic kidney disease afflicts about 20% of all diabetics and is the major cause of endstage renal disease (ESRD) which is an enormous drain on healthcare expenditures. Mortality rates of ESRD patients can reach 20% annually. Pyridorin(TM) has been awarded Fast Track status by the FDA due to the unmet medical need of this lifethreatening disease.

About NephroGenex, Inc.

NephroGenex is a drug development company focusing on kidney disease. More than 20 million Americans have some form of chronic kidney disease, and over 400,000 in the US have end stage renal disease requiring dialysis, making renal disease one of the costliest illnesses to treat. The Company is developing Pyridorin(TM) (pyridoxamine dihydrochloride) as a treatment to slow the progression of diabetic kidney disease. Pyridorin(TM) has demonstrated a significant treatment effect in slowing the progression of diabetic nephropathy in two Phase IIa clinical trials, and has been awarded Fast Track status by the FDA. Pyridorin(TM) is one of only a few drug candidates in advanced clinical trials for diabetic kidney disease, and possesses a distinctly new mechanism of action over currently approved treatments. NephroGenex will seek a partner for Phase III development and commercialization.

Source NephroGenex, Inc

Urovalve announced the successful results of a feasibility study of the Valve component of its Surinate® Bladder Management System designed to improve the quality of life of men who suffer from acute or chronic urinary retention, which is an inability to empty the bladder caused by obstruction of the urethra.

The feasibility study was designed to evaluate whether the beta version of the Surinate® Valve is safe and functional in a realuse situation (i.e., when attached in line with a Foley catheter) and to provide information to guide the design of future clinical studies. This feasibility study was reviewed and approved by an IRB (Investigational Review Board) for each of the investigational sites as a nonsignificant risk (NSR) study. Therefore, an IDE (Investigational Device Exemption) application did not need to be submitted to, or approved by, the FDA. The target indication for the eventual marketed System will be for controlled urinary drainage in male subjects. However, the purpose of this feasibility study was to assess the performance only of the Valve (which is one component only of the eventual marketed device) and not of the entire System.

“Today, men who have a urinary retention condition must rely on a 50yearold product called the Foley catheter, or intermittent catheterization four to six times a day,” said Harvey D. Homan, Ph.D., President and CEO of Urovalve. “Surinate® is designed so that the patient is no longer coupled to a urinecollection bag on his leg, which means of course that no one has to know that the patient has a urinary retention condition.

“Just as important,” added Dr. Homan, “is the fact that Surinate® is designed with a magnetized valve inside the catheter that allows the bladder to fill and then empty only on command of the patient. In addition, the patient uses an external magnet to open the valve in the Surinate® catheter to drain the bladder only when he needs to. Bottom line? The patient himself has total control over his bladderemptying process.

“This successful feasibility study has provided valuable information regarding the design and use of the beta version of the Surinate® Valve, which will be incorporated into future clinical evaluations,” Dr. Homan explained. “The most significant of these findings were first, that the Valves performance exceeded specifications; second, that encrustation does not appear to be a significant problem affecting the Valves performance; and third, that leaching of samarium or cobalt does not appear to occur, nor does it pose a significant risk to subjects. With these results, we look forward to announcing commencement of a pilot study of the beta version our of complete Surinate® system before yearend.”

New research sponsored by the UKs Alzheimers Society suggests that having an infection like a cold or stomach bug may hasten memory loss in people with Alzheimers disease.

The research was the work of Dr Clive Holmes of the University of Southampton in the UK, and colleagues, and is to appear as a paper this week in an advanced online September 2009 issue of the journal Neurology.

Commenting on the research, the Alzheimers Society said

“People with Alzheimers disease who develop an infection need to be treated as soon as possible to prevent it worsening their dementia.”

Holmes and colleagues were investigating how inflammatory proteins released during common infections might affect the brain.

One such inflammatory protein is tumor necrosis factoralpha, and they found that people with common infections such as a cold, stomach bug, urine infection, or even bumps and bruises from a fall, had higher levels of this inflammatory protein in their blood, and were also more likely to experience memory loss and other types of cognitive decline than counterparts who did not have infections and who had low levels of the inflammatory protein.

At the start of the study, Holmes and colleagues examined blood samples and cognitive abilities of 222 people with Alzheimers disease and whose average age was 83. The examination was repeated three more times over the next six months and the researchers also interviewed caregivers to find out about infection rates and accidental injuries that could lead to inflammation.

The results showed that110 of the participants experienced an infection or inflammationcausing injury over the six months of the study.
These 110 participants had twice the rate of cognitive decline of people who did not have any infections or injuries during the period of the study.
Participants who already had high levels of inflammatory protein in their blood at the start of the study (an indicator of chronic inflammation), showed four times the rate of cognitive decline of those whose levels were low at the start of the study.
And those who had high levels of the protein at the start of the study, and who also had acute infections during the course of the six months, experienced 10 times the rate of cognitive decline of those who started the study with low levels of inflammatory protein and had no infections during the six months of the study.Head of Research, Alzheimers Society, Dr Susanne Sorensen, told the media that while we know there might be a link between inflammatory processes and Alzheimers we dont really know much about it. So

“This study is an important step towards understanding the processes that occur during the onset of Alzheimers disease.”

“More research is now needed to further this line of investigation,” she added.

In the meantime older people, people with dementia, and their carers should treat all infections seriously and make sure they see their doctor. Health professionals treating Alzheimers patients should also be extra vigilant about infections and make sure they are dealt with promptly and effectively, said the Alzheimers Society in a press statement.

Commenting on how strongly the evidence suggests that it is inflammation that causes cognitive decline and not the other way around (given that the study could only examine correlations and thus only show the strength of the link, not the direction of cause) Holmes accepted that one way of looking at the results would be to suggest people who had a rapid rate of cognitive decline were more likely to have infections or injuries, but if he had to guess he would say it was not that way around, because

“We found no evidence to suggest that people with more severe dementia were more likely to have infections or injuries at the beginning of the study.”

“More research needs to be done to understand the role of tumour necrosis factoralpha, but its possible that finding a way to reduce these levels could be beneficial for people with Alzheimers disease,” said Holmes.

“Systemic inflammation and disease progression in Alzheimer disease .”
C. Holmes, C. Cunningham, E. Zotova, J. Woolford, C. Dean, S. Kerr, D. Culliford, and V.H. Perry.
Neurology; 73 (10) 768, in print 8 September 2009.

Source American Academy of Neurology, Alzheimers Society.

Written by Catharine Paddock, PhD

Two new genes associated with Alzheimers disease have been discovered in a British scientist led genome study.

In a separate study French researchers revealed links between a third gene and the disease.

The British study, led by Professor Julie Williams, is the largest ever Alzheimers genomewide association study and involved 16,000 individuals. Using a two stage process it identified strong links between the genes CLU and PICALM and Alzheimers. The French study of more than 7,000 individuals found a further link to the gene CR1. Both studies are being published in Nature Genetics this week.

Alzheimers Society comment

These studies mark a really exciting breakthrough in the ongoing efforts to identify a cause and find a cure for this devastating disease. It is the first time a new gene link has been established in 16 years and the role of British scientists shows the high standards being set by this countrys researchers.

These discoveries will enable scientists to follow new avenues of investigation as they piece together the causes of Alzheimers disease likely to be a mixture of genes; life style and life events. Most importantly it could also lead to new drug treatments.

In the next 10 years one million people will develop dementia but the government currently spends eight times less on dementia research than cancer research. This investment now needs to be drastically increased so we do not miss out on the incredible opportunity to build on these findings and ultimately win the battle against dementia.

Dr Susanne Sorensen
Head of Research
Alzheimers Society

Notes

Genomewide association study identifies variants at CLU and PICALM associated with Alzheimers disease by Williams et al is published in Nature Genetics on 6th September 2009.

Brown University neuroscience professor Gilad Barnea will receive a nearly $1.3 million, fouryear federal grant toward development of a method to selectively monitor the activation of each of the five receptors for the neurotransmitter dopamine in the brain.

If he succeeds, the achievement could lead to more targeted treatments for several mental illnesses and a number of other diseases.

“It can make a big impact on the development of new drugs for multiple disorders,” said Barnea, assistant professor of neuroscience.

The award, known as a EUREKA grant, is funded by the National Institutes of Healths National Institute of Mental Health. EUREKA grants for Exceptional, Unconventional Research Enabling Knowledge Acceleration are part of a new NIH initiative, less than two years old, that funds innovative, highrisk/high reward research.

Barnea will use the funding to develop a method for selectively monitoring the activation of each of the five dopamine receptors in the brain, without interference from the others. Such an advance matters because often several different receptors, beyond the one that physicians and scientists wish to target, respond to the same drug. This imperfect process leads to side effects from drugs that could be more beneficial if they worked in a more precise way. The membranes of all the cells in the body contain many receptors that receive signals from outside the cell and translate them into various responses inside the cell. These responses can include alteration of gene expression.

The ability to monitor the activation of a single dopamine receptor would be crucial for developing more precise and effective treatments for several mental disorders such as schizophrenia, bipolar disorder and attention deficit hyperactivity, as well as for other disorders such as addiction, Parkinsons disease and hypertension.

The longterm implications of Barneas success are even larger. Dopamine receptors belong to the family of G Protein Coupled Receptors (GPCRs the largest family of receptors in the body) that respond to a variety of stimuli including various hormones and neurotransmitters. Due to their pivotal role controlling a variety of physiological signals, GPCRs are common targets for pharmaceutical therapies, including treatments for psychiatric conditions, hypertension, asthma, allergies, peptidic ulcers and certain cancers. Barnea believes that the method, once developed and proven successful, could be applied to other types of GPCRs. If so, the concept cold have a broad impact both on the understanding of the physiology of these receptors, and on the development and testing of specific drugs for a wide range of illnesses, all with fewer side effects.

For the study, Barnea and his lab plan to develop several strains of mice in which the specific types of dopamine receptors will be monitored.

Barnea said he developed the idea that led to the EUREKA award from his main focus on understanding how the brain analyzes the information it receives from the nose to perceive scents.

To do this, Barnea has been developing a new system for labeling neural circuits across synapses in the brain. Some elements of this system, he said, could be reconfigured and modified to address the newer question about dopamine receptors and other GPCRs.

Source
Mark Hollmer