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Monday, March 22, 2010

Imaging tests used in diagnosis of possible PE vary: Study

The imaging tests used in the diagnosis of possible pulmonary embolism (PE) vary by physician specialty and geographic region, which suggests that some of this imaging may be inappropriate, according to a study in the April issue of the American Journal of Roentgenology (www.ajronline.org).
PE, the formation of a blood clot in the lung, is the third-leading cardiovascular cause of death. As such, it requires prompt diagnosis and treatment. The most common imaging tests used in the diagnosis of PE include computed tomography (CT) angiography and ventilation-perfusion scintigraphy (VQ scanning). Other imaging tests frequently performed on patients with symptoms of PE - often to rule out other diagnoses - include echocardiography, cardiac perfusion imaging, and duplex ultrasound.
Researchers from the American College of Radiology in Reston, VA, Philadelphia, PA, and the University of Pennsylvania analyzed data on Medicare patients with emergency department visits or inpatient stays with a diagnosis of PE or for symptoms related to PE. "For patients for whom PE might have been suspected, many large variations were found in practice patterns among physician specialties and geographic locations," said Rebecca Lewis, an author of the study. "There were fewer variations among patients with the inpatient diagnosis of PE," said Lewis.
"There are substantial differences in patterns of use of tests across geographic areas, probably reflecting differences in physician practice patterns," she said.
"Although physician practice in the diagnosis of PE is broadly consistent with recommendations, variations by physician specialty and geographic location may be evidence of inappropriate imaging," said Lewis.
Source:
American College of Radiology / American Roentgen Ray Society
http://www.news-medical.net/news/20100322/Imaging-tests-used-in-diagnosis-of-possiblePE-vary- Study.aspx
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Saturday, March 20, 2010

Sleep Deprivation Influences Drug Use In Teens' Social Networks

More than one behavior can spread simultaneously across a social network.

Recent studies have shown that behaviors such as happiness, obesity, smoking and altruism are "contagious" within adult social networks. In other words, your behavior not only influences your friends, but also their friends and so on. Researchers at the University of California, San Diego and Harvard University have taken this a step farther and found that the spread of one behavior in social networks in this case, poor sleep patterns influences the spread of another behavior, adolescent drug use.

The study, led by Sara C. Mednick, PhD, assistant professor of psychiatry at the University of California, San Diego School of Medicine and the VA San Diego Healthcare System, will be published March 19 in PLoS One.

"This is our first investigation of the spread of illegal drug use in social networks," said Mednick. "We believe it is also the first study in any age population on the spread of sleep behaviors through social networks."

Using social network data from the National Longitudinal Study of Adolescent Health, Mednick and her colleagues James H. Fowler, UCSD Department of Political Science and Nicholas A. Christakis, Harvard Medical School, mapped the social networks of 8,349 adolescents in grades 7 through 12. They found clusters of poor sleep behavior and marijuana use that extended up to four degrees of separation (to one's friends' friends' friends' friends) in the social network.

Another novel network effect that they discovered was that teens who are at the center of the network are at greater risk of poor sleep, which in turn means they are more likely to use marijuana putting them at the crossroads of two behaviors increases a teenager's vulnerability.

Contrary to the general assumption that drug use has a negative effect on sleep, the researchers also found that sleep loss is likely to drive adolescents to use drugs the less they sleep the more likely their friends are to sleep poorly and use marijuana.

"Our behaviors are connected to each other and we need to start thinking about how one behavior affects our lives on many levels," said Mednick. "Therefore, when parents, schools and law enforcement want to look for ways to influence one outcome, such as drug use, our research suggests that targeting another behavior, like sleep, may have a positive influence. They should be promoting healthy sleep habits that eliminate behaviors which interfere with sleep: take the TV out of the child's bedroom, limit computer and phone usage to daytime and early evening hours, and promote napping."

The research was funded by the National Institute of Mental Health, National Institute on Aging and National Institute of Child Health and Human Development.

Source: University of California, San Diego Health Sciences
http://www.medicalnewstoday.com/articles/182961.php

$1.2 Million Award from NIST Facilitates Groundbreaking Study Of Wireless Body Area Networks

WPI's Center for Wireless Information Network Studies (CWINS) has received a three-year, $1.2 million award from the National Institute of Standards and Technology (NIST) to conduct a groundbreaking study of the propagation of radio waves around and through the human body. Led by CWINS director Kaveh Pahlavan, professor of electrical and computer engineering, the research will help speed the development of and create standards for body area networks (BANs), a new generation of wireless networks that support a variety of medical applications, from monitoring the functioning of implanted devices to helping perform virtual endoscopic exams.

The award is one of only 27 funded (from 1,300 proposals), through NIST's AARA (American Recovery and Reinvestment Act) Measurement, Science & Engineering Grants program.

BANs are made up of compact medical sensors that can be worn by individuals or implanted in their bodies, depending upon the application. Data from the sensors are transmitted to base stations and then on to hospitals or clinics, where they may be monitored and analyzed. Data from these sensors can also be used to pinpoint the location of medical devices, for example implants or tiny sensors ingested to study the digestive system. Though most initial applications of BANs are expected to be in healthcare, the networks will likely find uses in many other areas. For example, they may be used to monitor athletes or military personnel.

BANs may make it possible for doctors and other healthcare professionals to remotely monitor patients around the clock. Data from a BAN installed in or on a person with a history of cardiac health issues, for instance, might alert doctors to heart rhythm irregularities, enabling emergency personnel to respond before a potentially fatal heart actually occurs. Similarly, BANs may make it possible for doctors to remotely monitor patients with diabetes, whose insulin levels could change abruptly, or people with seizure-causing disorders. And since BANs can be interactive, healthcare professionals could use them to deliver treatment from afar--for example, to patients with pacemakers or installed insulin pumps.

While BAN technology is still new, the industry is expected to grow rapidly in the coming years. Indeed, the FCC has recently allocated specific spectrum bands for wireless medical communications, and committees have been formed to address standardization of these emerging technologies. In fact, standardization is one of the areas that the WPI research aims to address, Pahlavan says. "Because innovations in wireless networks are based on radio propagation measurement science and engineering, standards committees devote considerable effort to measuring propagation characteristics," he notes. "It is essential to have consistent standards in order to evaluate the respective performances of alternative wireless solutions."

The goal of Pahlavan's team, which enjoys an international reputation for its research on radio frequency propagation and localization in wireless data networks, is to apply what it has learned by studying larger-scale networks (from wireless local networks such as Wi-Fi to personal networks like Bluetooth) to developing a comprehensive program for measuring the characteristics of radio frequency propagation in and around the body. Measurement and modeling of radio propagation and localization at such a small scale is expected to be challenging, Pahlavan notes. His lab will use a combination of empirical measurements, computational modeling and studies of phantoms (structures that simulate the characteristics of the human body) to complete the work.

"This research will help propel the growth of this powerful technology in the United States and help pave the way for standardization for body-area networks," Pahlavan says. "That growth, in turn, has both considerable economic implications and significant potential to improve healthcare." In addition to Pahlavan, the WPI team includes Sergey Makarov, professor of electrical and computer engineering, Allen Levesque, adjunct professor of electrical and computer engineering, and Ferit Akgul and Yunxing Ye, doctoral candidates in electrical and computer engineering.

Source:
Michael Dorsey
Worcester Polytechnic Institute
http://www.medicalnewstoday.com/articles/182929.php

Wednesday, March 10, 2010

Massage Eases Anxiety, But No Better Than Simple Relaxation Does

A new randomized trial shows that on average, three months after receiving a series of 10 massage sessions, patients had half the symptoms of anxiety. This improvement resembles that previously reported with psychotherapy, medications, or both. But the trial, published in the journal Depression and Anxiety, also found massage to be no more effective than simple relaxation in a room alone with soft, soothing music.

"We were surprised to find that the benefits of massage were no greater than those of the same number of sessions of 'thermotherapy' or listening to relaxing music," said Karen J. Sherman, PhD, MPH, a senior investigator at Group Health Research Institute. "This suggests that the benefits of massage may be due to a generalized relaxation response."

Massage therapy is among the most popular complementary and alternative medical (CAM) treatments for anxiety, she added. But this is the first rigorous trial to assess how effective massage is for patients with generalized anxiety disorder.

The trial randomly assigned 68 Group Health patients with generalized anxiety disorder to 10 one-hour sessions in pleasant, relaxing environments, each presided over by a licensed massage therapists who delivered either massage or one of two control treatments:
  • Relaxation therapy: breathing deeply while lying down
  • Thermotherapy: having arms and legs wrapped intermittently with heating pads and warm towels
All three treatments were provided while lying down on a massage table in a softly lighted room with quiet music. All participants received a handout on practicing deep breathing daily at home. Unlike the two control treatments, massage was specifically designed to enhance the function of the parasympathetic nervous system and relieve symptoms of anxiety including muscle tension.

Using a standard rating scale in interviews, the researchers asked the patients about the psychological and physical effects of their anxiety right after the 12-week treatment period ended and three months later, Dr. Sherman said.

All three of the groups reported that their symptoms of anxiety had decreased by about 40 percent by the end of treatment - and by about 50 percent three months later. In addition to the decline in anxiety, the patients also reported fewer symptoms of depression and less worry and disability. The research team detected no differences among the three groups; but the trial did not include a control group that got no treatment at all.

"Treatment in a relaxing room is much less expensive than the other treatments (massage or thermotherapy), so it might be the most cost-effective option for people with generalized anxiety disorder who want to try a relaxation-oriented complementary medicine therapy," Dr. Sherman said.

The National Center for Complementary and Alternative Medicine (NCCAM), part of the National Institutes of Health, funded this study.

Dr. Sherman's co-authors were Senior Investigator Daniel C. Cherkin, PhD, Assistant Investigator Andrea J. Cook, PhD, Senior Research Associate Evette J. Ludman, PhD, and Project Manager Rene Hawkes of Group Health Research Institute; Peter P. Roy-Byrne, MD, and Susan Bentley, DO, of the University of Washington; and Marissa Z. Brooks, MPH, LMP, of Portland State University and private practice.

Source:
Rebecca Hughes
Group Health Cooperative Center for Health Studies
http://www.medicalnewstoday.com/articles/181751.php

Intentional Variation Increases Result Validity In Mouse Testing

For decades, the traditional practice in animal testing has been standardization, but a study involving Purdue University has shown that adding as few as two controlled environmental variables to preclinical mice tests can greatly reduce costly false positives, the number of animals needed for testing and the cost of pharmaceutical trials.

Joseph Garner, a Purdue assistant professor of animal sciences, said the finding challenges the assumption in drug discovery and related fields that animal experiments should eliminate all variables. He said that despite standardization efforts, two experiments in different labs could never truly be exactly the same because of uncontrollable variables such as the scent of the researchers or background noises.

"Human drug trials get around this problem by deliberately including variability in the experiment in a controlled manner so that the effect of a drug can be tested across a variable human population," Garner said.

Garner and his co-authors compared results from multiple mice experiments set up in a standardized manner against multiple experiments set up with controlled variables as if the mice were people.

"Overall, the differences between experiments are much, much greater in the standardized setups than in the ones where we deliberately varied the environment as if the experiment was a human drug trial," said Garner, whose results were published in the current issue of the journal Nature Methods. "In fact, the traditional standardized experiments generally disagreed with each other, while the experiments designed like a human drug trial generally agreed with each other."

The study is a follow-up of another published last year in Nature Methods in which Garner, Hanno Würbel, a co-author on the papers and professor at the University of Giessen in Germany, and Helene Richter, Würbel's graduate student, suggested that adding controlled variation to animal experiments would lead to more accurate results. Garner said the original study, which demonstrated the idea in principle, had met resistance because it was unclear what environmental features scientists should vary to improve study results.

"In theory, if you introduce enough variables, it shouldn't matter what they are because you create spread in the mice. But other scientists were reasonable to ask whether this would be a practical approach. So, in this experiment, we wanted to address this concern and see whether it was logistically feasible to add enough variation to make the approach work." Garner said. "We were surprised by how little variation we needed to add. In fact, we found that using as few as two variables, regardless of what we actually varied, was enough to virtually eliminate disagreement between laboratories. Given our previous results, this should reduce the incidence of false positives five to tenfold."

Reducing false positives could be worth billions of dollars in the pharmaceutical industry where the cost of human clinical trials is high. Garner said about 90 percent of drugs thought to be effective in mice fail in human trials. Reducing the number of drugs that won't be successful could eliminate hundreds of millions of dollars per drug in some cases and reduce the cost of research and development.

"The real cost of producing a drug is the cost of all the drugs that were tested and failed at the same time, and this cost is passed on to the consumer," Garner said. "Weeding out these failures in animal trials could transform the economics of drug development."

Garner analyzed data from a series of behavioral tests Würbel performed in Germany. The tests compared behaviors commonly used in drug and gene discovery between two strains of mice. The experiment was repeated in four different model laboratories, each of which differed according to variables such as background noise, the age of the mice, lighting levels and cage size. In each laboratory, standardized mice were treated identically - as they would be in a traditional experiment - while heterogenized mice were tested in four different conditions made by varying two environmental variables in a controlled manner, just like a human drug trial.

Mice from the same strain should have exhibited the same behavior in each laboratory, such as showing fear and curiosity. However, in 33 of the 36 behavioral characteristics, variation was lower in the heterogenized design than the standardized design, and, on average, the standardized group exhibited as much as five times the variation between laboratories as the heterogenized group.

"The reason why this happens is because when you keep everything standardized, the variation is very low within the lab, but the variation between labs is huge and unpredictable," Garner said. "You would have to do the same experiment in many standardized labs to really know the true result, or you could do it in one lab with a heterogenized design, like a human drug trial, to find the true result. This is a win-win because you need to use far few animals, and you get a much better understanding of whether, for instance, a drug really does have an effect that is replicable."

Garner said the next step in the research is to do the same experiments in different labs across Europe to eliminate the simulation of labs in the experiment. The German Research Foundation funded the study.

Source:
Brian Wallheimer
Purdue University
http://www.medicalnewstoday.com/articles/181748.php

TechniScan Teams With Researchers At UC San Diego In Clinical Study With Warm Bath Ultrasound(TM) System

TechniScan, Inc. (OTC Bulletin Board: TSNI) ("TechniScan" or the "Company"), a medical device company engaged in the development and commercialization of an automated breast ultrasound imaging system, announced that it has commenced phase two of its grant study at the University of California, San Diego (UCSD) Moores Cancer Center.

TechniScan's Warm Bath Ultrasound (WBU™) system is designed to capture three-dimensional images of the breast as a woman lies prone on a table and state-of-the- art ultrasound technology is used in a warm water tank to capture images of the breast anatomy.

The Moores UCSD Cancer Center is a National Cancer Institute (NCI) designated comprehensive cancer center with scientists and clinicians focused on developing the next generation of cancer therapies and cures. The TechniScan Warm Bath Ultrasound™ system investigations will be conducted with Michael P. Andre, Ph.D., Professor of Radiology, and breast radiologists Dr. Linda Olson and Dr. Haydee Ojeda-Fournier.

Funded by a NCI Small Business Innovation Research Grant (SBIR) from the National Institute of Health, the study will involve approximately 130 women with various types of breast lesions. Major objectives of the 12-month study will be to compare WBU™ to conventional breast sonography and to examine the WBU™ system's ability to differentiate between normal, benign and malignant breast tissue.

"We are excited to begin this new phase in the development of WBU™; it marks a genuine milestone in which our work may be translated to the front lines of the clinical world, " said Andre.

Researchers involved in the study will also utilize TechniScan's groundbreaking imaging network, which provides them with the ability to archive, store, and retrieve WBU™ images and relevant medical records and to collaborate with other researchers at sites in Freiburg, Germany, Salt Lake City and Rochester, Minnesota.

"Our vision is to begin to create a database of thousands of breast images and related data," said Dave Robinson, chief executive officer at TechniScan, Inc. "With complete anonymity, women may contribute their mammograms, breast MRI's and WBU™ images, along with related pathology and other information, to provide researchers around the world an unprecedented opportunity to study breast cancer. TechniScan's imaging network will also allow timely and efficient collaboration of patient's records for her medical team's use. The concept is simple, yet revolutionary within the medical system and represents a key competitive advantage of the TechniScan system."

About TechniScan, Inc.

Based in Salt Lake City, TechniScan, Inc. is a medical device company engaged in the development and commercialization of a non-invasive imaging tool designed to provide physicians with automated ultrasound images of the human breast. The system uses a process called Warm Bath Ultrasound (WBU™) to provide physicians with automated, 3-D, ultrasound images of the physical structures within the breast. TechniScan's WBU™ imaging device is limited by U.S. law to investigational use unless, and until, cleared by the FDA.

Source: TechniScan, Inc
http://www.medicalnewstoday.com/articles/181747.php

Monday, March 8, 2010

The Nanoscience/Neuroscience Intersection: A Dialogue

In a far-reaching dialogue, three researchers -- Nicholas Spitzer, Kwabena Boahen and Hongkun Park -- discuss the synergy between nanoscience and neuroscience, what it means for the future, and how it is driving current research

Is it possible to build supercomputers that can replicate the human brain, or to develop nanotechnology that can lead to an implantable chip for interfacing with neurons and other types of cellular networks?

Once divergent fields, nanoscience and neuroscience are now advancing each other in ways that could propel extraordinary new research. Just what this means was the topic of an hour-long conversation recently led by neuroscientist Nicholas Spitzer. Professor of Neurobiology and Co-Director of the Kavli Institute for Brain and Mind at the University of California, San Diego, Spitzer is responsible for groundbreaking studies into the activity and development of neurons and neuronal networks that span more than four decades. Spitzer explored this scientific intersection with two pioneering researchers in nanoscience:
  • Kwabena Boahen, Associate Professor of Bioengineering at Stanford University, who is using silicon integrated circuits to emulate the way neurons compute, bridging electronics and computer science with neurobiology and medicine. At Stanford, his research group is developing "Neurogrid," a hardware platform that will emulate the cortex's inner workings.

  • Hongkun Park, Professor of Chemistry and of Physics at Harvard University, who is known for his work in developing computing technology modeled after the human brain and nervous system. Park is pushing the frontiers of nanotechnology by developing devices capable of probing and manipulating individual neurons.
In a far-reaching dialogue, the researchers discussed the synergy between nanoscience and neuroscience, what it means for the future, and how it is driving their current research -- ranging from the development of a "Neurogrid" hardware platform that would emulate the cortex's inner workings, to creating nanowire platforms for administering biochemicals to cells.

Story (with transcript) is available at: http://www.kavlifoundation.org/Spitzer-Boahen-Park

Source:
James Cohen
The Kavli Foundation
http://www.medicalnewstoday.com/articles/181410.php

Are You At Risk For Age-Related Macular Degeneration (AMD)? Learn The Top 5 Risk Factors

Age-related macular degeneration (AMD) is a leading cause of severe vision loss among Americans ages 65 and over. Knowing your risk factors, being aware of your family history, and keeping regular appointments with your Eye M.D. can help reduce your risks for vision loss from macular degeneration. In its most severe form, known as wet AMD, the disease can lead to permanent loss of central vision which is essential for driving, reading, and recognizing faces.

March is AMD Awareness Month, and the American Academy of Ophthalmology, through its EyeSmart™ Campaign, encourages Americans to know their risks for AMD.

"The past few years have been marked by significant improvement in understanding the causes and the treatment of AMD," says George Williams, MD, an AMD expert and Academy clinical correspondent. "New research and clinical advances are helping us to better treat both the "dry" AMD and "wet" forms of AMD. One strong risk factor that people may not be aware of is family history. It's important to find out whether your relatives have had AMD, and to tell your Eye M.D., if you have a history of AMD in your family. Knowing your risks can save your sight."

Here are the top 5 risk factors for AMD:

- Being over the age of 60
- Having a family history of AMD
- Cigarette smoking
- Obesity
- Hypertension

If you have any two of these risk factors, you should schedule an appointment with your Eye M.D for a complete evaluation. Your Eye M.D. may recommend certain preventive measures which can reduce your risk of vision loss from this disorder.

People who are at risk should know the symptoms of wet AMD, the form most likely to cause rapid and serious vision loss. These include sudden, noticeable loss or distortion of vision, such as seeing "wavy" lines. See an Eye M.D. right away if these symptoms occur. Current treatments for wet AMD provide an excellent chance of stopping vision loss and may actually restore some vision when macular degeneration develops. Earlier diagnosis of wet AMD gives a better chance of successful treatment.

There are some AMD risk factors that a person can change such as smoking and diet to reduce the risk of vision loss from AMD. Other risk factors such as genetic factors cannot be changed. However, knowing your family medical history is one way to learn whether you may be genetically predisposed to a disease. One way to reduce AMD risk is to quit smoking or never start. For patients at high risk for developing late-stage AMD, taking a dietary supplement of vitamin C, vitamin E and beta carotene, along with zinc, has been shown to lower the risk of AMD advancing to advanced stages by 25 percent. Patients should check with their Eye M.D. before starting any dietary supplement.

About AMD

The disease takes two forms, termed "dry" and "wet."

- Early-stage AMD: Yellow deposits called "drusen" develop under the retina, the light-sensitive tissue at the back of the eye that focuses images and relays them to the optic nerve. At this stage, most people would do not have reduced vision.

- Intermediate AMD: Patients have more and larger drusen and more pigment changes in the macula (the part of the retina responsible for central vision); they are at higher risk for both advanced dry and wet AMD. The majority of those with intermediate AMD do not progress to an advanced stage, but should be followed by an Eye M.D. so they can be treated if needed.

- Advanced "dry" AMD: Patients with more advance dry AMD may have a blind spot in their central vision. Currently there is no proven therapy to restore vision lost from advanced dry AMD. Low-vision technologies, including improved lighting and magnification, help maintain their quality of life.

- Advanced "wet" AMD: In this stage, abnormal blood vessel form under the retina. These blood vessels can leak fluid or bleed and cause sudden and drastic loss of central vision.

Although only about 10 percent of the 10 to 15 million Americans with AMD have the "wet" form, it is responsible for most severe vision loss. New, highly effective treatments such as the injectable medications ranibizumab and bevacizumab are dramatically reducing damage from "wet" AMD and can stabilize vision in more than 90 percent of patients and actually improve vision in up to 30 to 40 percent of patients.

For more information about AMD and other eye diseases, visit http://www.geteyesmart.org.

Source
American Academy of Ophthalmology

http://www.medicalnewstoday.com/articles/181433.php

Argos Therapeutics Publishes Positive Immune Response, Safety And Manufacturing Data For Its Arcelis™ HIV Program In Clinical Immunology

Argos Therapeutics announced the publication of a manuscript in the February edition of Clinical Immunology, detailing positive immune response, safety and manufacturing data for its AGS-004 immunotherapy for HIV. AGS-004 is a product of the Company's Arcelis™ technology, and is a personalized, RNA-loaded dendritic cell-based immunotherapy that is perfectly matched to each patient's unique HIV viral burden. The manuscript details a clinical study in which AGS-004 was evaluated in type-1 HIV-infected adults who were being treated with antiretroviral therapy (ART). The study demonstrated that AGS-004 is capable of producing a proliferative T cell response to HIV-1 antigens in patients, with full or partial HIV-specific proliferative immune responses occurring in 78% of evaluable subjects.

"While ART improves the morbidity and mortality associated with HIV, it does not improve the immune system's ability to control HIV replication, and it is also associated with significant side effects for patients," said Principal Investigator Jean-Pierre Routy, M.D., from McGill University Health Centre in Montreal. "A new treatment strategy is needed that could potentially limit or delay exposure to ART and its accompanying side effects, and I believe that an immunotherapeutic approach may be able to achieve this, through producing or enhancing the anti-HIV immune responses needed to control viral replication."

Charles Nicolette, Ph.D., Chief Scientific Officer and Vice President of Research and Development of Argos Therapeutics, added, "We are excited about the Arcelis immunotherapy platform because it is so well suited to the pathology of HIV infection; it overcomes the viral variability and the immune suppressive mechanisms that allow the virus to persist chronically and, remarkably, this is achieved without activation of CD4+ T cells, which are known to serve as factories for viral replication. This current study confirms previous proof-of-concept studies that have shown that our approach is able to induce a diverse immune response to HIV in patients."

AGS-004 is produced from autologous, monocyte-derived dendritic cells that are electroporated with RNA encoding for CD40L and for HIV antigens Gag, Nef, Rev, and Vpr, derived from each patient's pre-ART plasma. Data from this study show that four patients demonstrated increases in T cell proliferation specific to the four HIV antigens used in AGS-004, which met the criteria for a full response; three additional subjects demonstrated increases that represented partial responses to AGS-004 therapy. Importantly, HIV viral load was undetectable at baseline and throughout the duration of the study for all subjects.

Reported adverse events were all mild in nature, with no evidence of autoimmunity, and no significant changes in absolute CD4+ and CD8+ cell counts were observed. No subjects discontinued the study due to any adverse event. The study also demonstrated the manufacturing feasibility of AGS-004, which was produced according to current Good Manufacturing Procedures, with AGS-004 being produced within a mean of 6 weeks and yielding 4-12 doses per patient.

"This study demonstrates both the clinical and commercial potential of AGS-004 for HIV therapy," said Jeff Abbey, President and CEO of Argos. "In addition to the promising immune response data observed, we have also received important data detailing a potentially favorable safety profile, as well as validation for our proprietary immunotherapy manufacturing process. Based on the strong results we have observed so far, we are near completion of a Phase 2a trial of this candidate in HIV, and will initiate a Phase 2b double blind placebo controlled study this year."

About the Study

The primary endpoint of this study was the change from baseline of the proliferative capacity of CD8+ T cells in response to the four HIV RNA-encoded antigens expressed in AGS-004. The success of the manufacturing process was measured by the ability to produce AGS-004 and provide the first dose to each subject within 12 weeks of initial leukapheresis. The study enrolled adults with HIV-1 infection who had plasma HIV RNA levels of fewer than 200 copies/mL, CD4+ T cell counts of greater than 350 cells/mm3, and who had been receiving their first ART regimen for at least 12 weeks prior to enrollment. AGS-004 was successfully generated and administered to 10 subjects, and 9 enrolled subjects were evaluable for the primary endpoint. Patients received monthly injections of AGS-004 in combination with ART.

Development of the Argos HIV program is funded in part with federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. N01-AI-60019, and by CANVAC (HIV-001) and the Canadian Trials Network (CTN) Study No. 229, from whom we have a contract for the development of our HIV program.

The manuscript, titled, "Immunologic activity and safety of autologous HIV RNA-electroporated dendritic cells in HIV-1 infected patients receiving antiretroviral therapy," was authored by Jean-Pierre Routy, Mohamed-Rachid Boulassel, Bader Yassine-Diab, Charles Nicolette, Don Healey, Renu Jain, Claire Landry, Oleg Yegorov, Irina Tcherepanova, Tamara Monesmith, Lothar Finke, and Rafick-Pierre Sekaly.

About the Arcelis™ Technology

Arcelis is Argos' proprietary technology for personalizing RNA-loaded dendritic cell immunotherapies for HIV, other infectious diseases, and cancer. This platform is based on optimizing a patient's own (autologous) dendritic cells to trigger a pathogen- or tumor-specific immune response. To address the challenge of the unique genetic profile of each patient's disease and the genetic mutations of that disease, Argos loads the autologous dendritic cells with a sample of messenger RNA ("mRNA") isolated from their disease. Through this process, dendritic cells can potentially prime immune responses to the entire antigenic repertoire, resulting in an immunotherapeutic that is customized to the patient's specific disease.

Source
Argos Therapeutics, Inc.
http://www.medicalnewstoday.com/articles/181427.php

Johnson & Johnson Consumer Companies, Inc., Unveils CYTOMIMIC™ Technology At 68th Annual Meeting Of The American Academy Of Dermatology

Building on decades of research into how the body's electrical field affects skin regeneration, scientists at Johnson & Johnson Consumer Companies, Inc., have discovered how to harness the power of bioelectricity to help improve skin rejuvenation. The new innovation, called CYTOMIMIC™ Technology, is a proprietary, patented technology that combines essential minerals to deliver biological levels of electric signals similar to the skin's natural bioelectricity. CYTOMIMIC™ Technology will be introduced to the dermatologic community and featured in nine scientific posters at the 68th Annual Meeting of the American Academy of Dermatology (AAD), March 5-9, 2010, at the Miami Beach Convention Center.

"CYTOMIMIC™ Technology mimics the body's natural bioelectricity to help rejuvenate, repair and renew skin," says Dr. Ying Sun, a Distinguished Research Fellow and Science Leader for an internal growth platform venture at Johnson & Johnson Consumer Companies, Inc. "We combine essential minerals in a first-of-its-kind delivery system to deliver biological levels of electric signals similar to the skin's natural bioelectricity."

The clinical studies that demonstrate improvement of the skin's appearance starting within minutes of application with continued improvements over time have been accepted and will be on display at what is considered the largest and most prestigious gathering of dermatologists. With more than 19,000 physicians from around the world attending the Annual Meeting in 2009, this yearly gathering's stated objective is to link research and clinical findings to practice, with the ultimate goal to advance dermatology care.

The scientific posters that feature CYTOMIMIC™ Technology include:

- Biomimetic Electricity Generated by an Elemental Bi-mineral Complex Produces Anti-Inflammatory Activity
- Biomimetic Electricity Generated by an Elemental Bi-mineral Complex Increases Extracellular Matrix Production in Human Skin Explants
- Biomimetic Electricity Generated by an Elemental Bi-mineral Complex Inhibits Melanogenesis via Suppressing Tyrosinase Expression
- Safety and Tolerability of a Topical Bi-mineral Complex that Generates Biomimetic Signals
- Biomimetic Signaling Technology Generated by a Bi-mineral Complex Demonstrates Efficacy in Reducing Clinical Photo-aging in a 12-Week Placebo-Controlled Study
- Biomimetic Signaling Technology Generated by a Bi-mineral Complex Reduces Signs of Photo-aging in the Eye Area
- A Cosmetic Product Containing Biomimetic Signaling Technology to Improve the Aging Signs in the Eye Area
- Clinical Improvements in Facial Photo-Aging with Topical Application of a Biomimetic Mineral Complex and Naturals Extract Formulation
- Facial Moisturizer Featuring Biomimetic Signaling Technology from a Bi-mineral Complex Reduces Skin Laxity

The abstracts will be displayed as electronic posters in Poster Exhibit Hall D. One of the abstracts has the added distinction of also being selected for a Poster Discussion. "Biomimetric Signaling Technology Generated by a Bi-mineral Complex Demonstrates Efficacy in Reducing Clinical Photo-aging in a 12-Week Placebo-Controlled Study," Poster P304, will be presented on Sunday, March 7th from 7:25 -7:35 a.m. in Room D229/230.

This patented technology was discovered in 2004 by Dr. Sun and his colleagues Dr. Jue-Chen Liu and Jeannette Chantalat. Today, Johnson & Johnson Consumer Companies holds 10 U.S. patents active until 2023 and has multiple U.S. and international applications pending.

CYTOMIMIC™ Technology: How It Works

Bioelectricity is the body's native electrical signaling process that helps direct physiological activities at the cellular level, such as the skin's own rejuvenation process. When applied topically, CYTOMIMIC™ Technology can help to rejuvenate and maintain healthy-looking skin.

As we age, bioelectrical signals naturally diminish which can result in decreased cell-to-cell communication, production of essential proteins such as collagen and elastin, and in healing abilities. This can result in fine lines and wrinkles, loss of firmness and sagging skin.

The science of CYTOMIMIC™ Technology is based on creating and delivering biological levels of electricity directly to the skin, naturally stimulating the intrinsic rejuvenation process. This innovation is based on the design of a proprietary technology - energized micro-particles of zinc and copper - captured in a unique delivery system that helps stimulate the body's own rejuvenation processes. When activated by moisture, these energized micro-particles act as "miniaturized batteries" that help jumpstart healthy skin function. These micro-particles stay on the skin's surface and mimic the body's native electrical signals, to rebuild and restore youthful-looking skin.

Benefits of CYTOMIMIC™ Technology

CYTOMIMIC™ Technology represents a major advancement in skincare, because it's the first technology designed to deliver electricity at a scale that safely simulates the body's own bioelectricity levels in the form of a topical treatment, resulting in:

- Improved cell activity, evidenced in vitro by enhanced expression of collagen and elastin
- Accelerated improvement in reducing the signs of aging, even in the delicate skin around the eyes
- Improved skin texture, firmness and radiance
- Demonstrated anti-inflammatory activity to address a potential cause of aging

Clinical Data on CYTOMIMIC™ Technology

Johnson & Johnson Consumer Companies, Inc., has evaluated CYTOMIMIC™ Technology on more than 1,000 individuals/subjects in clinical and safety studies over 2.5 years, and has demonstrated improvement of the skin's appearance within minutes of application and continued improvements over time.1

CYTOMIMIC™ Technology is clinically proven to significantly reduce the hallmark signs of aging, in some cases in as little time as 30-minutes, by:

- Diminishing the appearance of bags under the eyes and periorbital fine lines and wrinkles
- Reducing the look of dark circles
- Reducing the look of fine lines and wrinkles
- Lifting appearance of the eyes
- Reducing the appearance of crow's feet wrinkles
- Improving radiance and brightness
- Lifting, firming, and enhancing jawline contours
- Improving skin softness and smoothness

"Because the technology is developed based on an understanding of how skin heals and uses bioelectricity, it is potentially transferable to all the other different tissues in our body," says Jeannette Chantalat, Manager of Research & Development at Johnson & Johnson Consumer Companies, Inc. "Bioelectricity is critical to communication; it's the universal language of the body."

1. Internal Johnson & Johnson Consumer Companies, Inc., document, Innovation Summit. June 23, 2009

Source
Johnson & Johnson Consumer Companies, Inc.
http://www.medicalnewstoday.com/articles/181444.php

Tuesday, March 2, 2010

Ownership/Leasing Of PET Scanners By Nonradiologists On The Rise

Just as with computed tomography (CT) and magnetic resonance imaging (MRI), the growth rate among non-radiologists who own or lease positron emission tomography (PET) equipment is also on the rise, contributing significantly to the ongoing issues surrounding self-referral and unnecessary utilization of imaging in the United States, according to a study published in the March issue of the Journal of the American College of Radiology. PET is a relatively new technology that produces three-dimensional images of functional processes in the body. It is often used to diagnose certain types of cancer and heart disease.

"One of the well-known factors contributing to rising imaging costs is self-referral among non-radiologist physicians which has been shown to result in unnecessary utilization of imaging," said Rajan Agarwal, MD, MBA, lead author of the study. "This has made imaging one focus of concern as policymakers and third party payers look to cut health care costs," said Agarwal.

Data was collected utilizing the Medicare Part B Physician/Supplier Procedure Summary Master Files for 2002 through 2007. The number of PET scans performed on units owned or leased by various medical specialists, including radiologists was tabulated. While overall imaging growth is in line with or below that of other physician services - 2 percent or less annually since 2006 - utilization by non-radiologists continues to significantly outpace that of radiologists.

"Results showed that while a large percentage of PET scans in private offices are done by radiologists, the growth rate among non-radiologists was much higher. Between 2002 and 2007 radiologist-owned Medicare PET scans increased by 259 percent, whereas non-radiologist owned or leased scans grew by 737 percent - a significant difference," said Agarwal.

"At a time when the costs of imaging and the exposure of patients to radiation are coming under intense scrutiny, it is of great concern that many non-radiologist physicians are going outside the scope of their original specialty training and practice experience by acquiring and leasing advanced imaging equipment such as PET scanners," he said.

"Because it has been clearly shown that self-referral leads to higher utilization of imaging this is likely already a significant driver of utilization increases and costs, and it of course also leads to greater exposure of patients to radiation. As was the case with CT and MRI, the PET growth trend among non-radiologists remains high and will bear further watching in future years," said Agarwal.

Source:
Heather Curry
American College of Radiology / American Roentgen Ray Society
http://www.medicalnewstoday.com/articles/180757.php

Embedding Images In Radiology Reports Can Speed Decision Making And Improve Patient Care

Embedding clinical images to accompany findings described in a radiology text report enhances radiologists' communication with referring physicians and can improve patient care, according to a study in the March issue of the Journal of the American College of Radiology.

"The imaging exam report provides an important means of communication between the radiologist and the other physicians rendering care and is often the only form of communication between the radiologist and the referring physician," said Veena R. Iyer, MBBS. It has been suggested that providing the referring physician with selected images embedded in the text report over the web could improve and support the information contained in the report. "We undertook this study to measure the utility to the referring physician, of radiology reports with attached, relevant images of the abnormal findings," said Iyer.

Thirty-five cases referred for abdominal computed tomography (CT) scans were included in the study, which was performed at Massachusetts General Hospital. Referring physicians were asked to view a text-only report followed by the same report with pertinent embedded images. "In 32 of the 35 cases, the text-only report satisfactorily answered the clinical query. In these 32 cases, the report with the attached images helped in making a more confident management decision and reduced time in planning management. Attached images altered management in two cases," said Iyer.

"The results of our study indicate that although clinician's queries are satisfactorily answered by the current itemized report, providing additional images conveys useful information. It may enable the referring clinician to formulate response plans more rapidly and with increased confidence," she said.

"Providing referring clinicians with a selected subsample of relevant images attached to the report improves the radiologist's communication with them. Such a report has the ability to save the clinician's time, and possibly improve patient management," said Iyer.

Source:
Heather Curry
American College of Radiology / American Roentgen Ray Society
http://www.medicalnewstoday.com/articles/180758.php

New Technique Allows Study Of Protein Folding, Dynamics In Living Cells

A new technique to study protein dynamics in living cells has been created by a team of University of Illinois scientists, and evidence yielded from the new method indicates that an in vivo environment strongly modulates a protein's stability and folding rate, according to research accepted for publication in the journal Nature Methods and posted on the journal's Web site Feb. 28.

Martin Gruebele, the James R. Eiszner Professor of Chemistry at Illinois and corresponding author of the paper, says the method that he and his team of co-researchers engineered marks the first time anyone has been able to follow the real-time folding and unfolding of proteins outside of a test tube.

"This is the first experiment that allows us to observe the dynamics of a protein folding in a live cell," Gruebele said. "Now we have the capability of looking at how fast biological processes occur as a function of time."

To study the biomolecular dynamics inside of a single living cell, Gruebele and his team pioneered a hybrid method they've dubbed "Fast Relaxation Imaging," a technique that combines fluorescence microscopy and fast temperature jumps.

"It's a tool that combines two worlds: chemical dynamics, and the ability to study reactions as they occur; and biological environments, where cell biologists observe how reactions occur in cells," Gruebele said.

To achieve both a fast upward and downward temperature jump, programmed laser pulses are used to pre-heat, spike, plateau, cool and then finally stabilize the temperature in the cell and its aqueous medium at the final value. An inverted fluorescence microscope is used to observe and record what happens inside the cell, all of which takes place in the span of a few milliseconds.

The cells are usually heated to between 96 and 100 degrees Fahrenheit.

"It's like we give them a little bit of a fever," Gruebele said.

Gruebele says that although temperature jumps have been used for some time to study the kinetics of chemical reactions in vitro, that method is limited by what he calls "homogenous kinetics," or an inability to see the dynamics in different areas of the cell.

"We haven't really been able to study dynamics, to see if a chemical reaction like protein folding varies inside of a living cell," he said. "With temperature jumps and pressure jumps, you can do those experiments very quickly, but you don't get any imagery that lets you see if proteins fold faster in one region and slower in another," Gruebele said.

On the other hand, fluorescence microscopy allows researchers to see inside of cells, but it precludes them from studying cell dynamics and kinetics.

"With fluorescence microscopy, we're able to take images of cells and see inside them, but we can't observe how anything rapidly changes or adapts with time, so you can't look at any but the slowest dynamics. This experiment puts those two aspects together," he said.

Since biomolecular dynamics are predominantly studied in vitro, with the results extrapolated to explain how the same processes would function in a living cell, Gruebele says the new technique has yielded some interesting data that could change standard thinking in the field.

"If you perform experiments only in an artificial environment such as a test tube and not in a living cell, you only get one answer," Gruebele said. "It's a reproducible environment; therefore, it always gives you the same answer. If you do it in a cell, we find we get very different answers in different parts of the cell."

According to Gruebele, the proteins studied in vivo using the new technique were more stable, their thermal denaturation was more gradual and their folding kinetics were slower than the same proteins studied in vitro.

Gruebele said that in living cells, "You really expect a lot of heterogeneity, that there would be a lot of differences among different areas of the cell, that there might be areas of the cell where the protein might be very stable, and other places where it's very unstable. There might be places where it folds very quickly, and other places where it folds very slowly."

The reason for this heterogeneity is that proteins have to thread their way through whatever channel happens to be available, Gruebele said. And, as opposed to the expansive environment of a test tube, there's a lot of cellular furniture for proteins to bump into in living cells.

"You have a very simple, very homogenous environment when you study proteins in vitro," he said. "In a living cell, 30 to 40 percent of the contents are solids of some kind. There are big ones, like ribosomes, and walls, like cell membranes, all the way down to very small parts like other proteins or sugars. So there's really a huge distribution of all these different sizes that a protein has to wend its way around that may hinder it from freely expanding and contracting, as it would do when it unfolds and refolds in an artificial environment.

"So it's the environment, and not just an intrinsic property of the protein, that causes all these variations that we observed."

In addition to revealing the inner working of cell dynamics, Gruebele, who is also a researcher at the Beckman Institute, says Fast Relaxation Imaging will have practical, human-scale applications as well.

"With this new technique, we now have the capability of looking at how fast biological processes occur as a function of time, including potentially interesting disease processes, especially with neurological disorders and diseases that cause dementia such as Alzheimer's, Huntington's, Creutzfeldt-Jakob disease," he said.

There's also the potential to induce disease processes, and study the dynamics of those processes in a live animal study.

"We can take these proteins that cause these diseases, actually put them into the kind of cells where they cause these diseases, give them a heat shock and actually see if they bind differently to the membranes, if they cause the membrane to puncture," Gruebele said. "We'll be able to follow these events in real time and give researchers an idea of if this is a possible pathway through which disease could occur."

Gruebele's co-authors of the paper are Simon Ebbinghaus, a post-doctoral research associate; Apratim Dhar, a U. of I. student; and J. Douglas McDonald, a professor of chemistry.

Funding was provided by The National Science Foundation and the James R. Eiszner Chair.

Source:
Phil Ciciora
University of Illinois at Urbana-Champaign
http://www.medicalnewstoday.com/articles/180756.php