Past News Items - Jan 2014

A groundbreaking collaborative multi-site study found that teens and young adults undergoing the rigors of stem cell transplantation as part of cancer treatment gain coping skills and resilience-related outcomes when participating with a board-certified music therapist in a therapeutic music protocol that includes writing song lyrics and producing videos. Resilience is the process of positively adjusting to stressors. The study’s findings provide evidence supporting the use of a music-based intervention delivered by music therapists to help patients cope with challenging treatments.

Indiana University’s Sheri L. Robb, PhD, MT-BC, and Joan E. Haase, PhD, RN, FAAN, led the research team. The SMART study—“Stories and Music for Adolescent and Young Adult Resilience during Transplant”—involved 11 sites with 49 board-certified music therapists supporting the protocol. Published in Cancer, a peer-reviewed journal of the American Cancer Society, the findings indicate that such music therapy interventions can provide essential psychosocial support to help young patients positively adjust to cancer.

The music therapists’ role included helping patients identify and write about what was important to them through writing song lyrics, while also supporting their efforts to connect with healthcare providers, peers, and family through the process of creating their music video. While the intervention tested in this study requires delivery from a credentialed music therapist, it fosters involvement from patients’ entire team. The authors and AMTA advocate that nurses and other interdisciplinary team members collaborate with music therapists to identify patients/families who might benefit from this specific intervention—and use opportunities for involvement in the intervention to connect with their patients.

According to Dr. Robb, one challenge in healthcare is “making sure that research findings from studies such as ours are used to inform healthcare practices and service delivery. One of our team’s next steps is to disseminate findings, train professional music therapists on this intervention, and then conduct an implementation study to examine how the intervention may change as it moves into the standard care setting and whether, in the presence of these changes, patient benefits are maintained.”

Released: 01/24/14

Setting the Record Straight: What Music Therapy Is and Is Not

The American Music Therapy Association (AMTA) supports music for all and applauds the efforts of individuals who share their music-making and time; we say the more music the better! But clinical music therapy is the only professional, research-based discipline that actively applies supportive science to the creative, emotional, and energizing experiences of music for health treatment and educational goals. Below are a few important facts about music therapy and the credentialed music therapists who practice it:

Music therapists must have a bachelor’s degree or higher in music therapy from one of AMTA’s 72 approved colleges and universities, including 1,200 hours of clinical training.
Music therapists must hold the MT-BC credential, issued through the Certification Board for Music Therapists, which protects the public by ensuring competent practice and requiring continuing education. Some states also require licensure for board-certified music therapists.
Music Therapy is an evidence-based health profession with a strong research foundation.
Music Therapy degrees require knowledge in psychology, medicine, and music.

These examples of therapeutic music are noteworthy, but are not clinical music therapy:

A person with Alzheimer’s listening to an iPod with headphones of his/her favorite songs
Groups such as bedside musicians, musicians on call, music practitioners, sound healers, and music thanatologists
Celebrities performing at hospitals and/or schools
A piano player in the lobby of a hospital
Nurses playing background music for patients
Artists-in-residence
Arts educators
A high school student playing guitar in a nursing home
A choir singing on the pediatric floor of a hospital

Finally, here are examples what credentialed music therapists do:

Work with Congresswoman Giffords to regain her speech after surviving a bullet wound to her brain
Work with older adults to lessen the effects of dementia
Work with children and adults to reduce asthma episodes
Work with hospitalized patients to reduce pain
Work with children who have autism to improve communication capabilities
Work with premature infants to improve sleep patterns and increase weight gain
Work with people who have Parkinson’s disease to improve motor function

AMTA’s mission is to advance public awareness of the benefits of music therapy and increase access to quality music therapy services in a rapidly changing world. In consideration of the diversity of music used in healthcare, special education, and other settings, AMTA unequivocally recommends the unique knowledge and skill of board certified music therapists.

For more information on this topic please visit the American Music Therapy Association at musictherapy.org and click on the Research tab.

Released: 01/23/14

New Clinical Study Affirms Plant Sterol/Stanol Liquid Softgel Supplement as Effective Means of Lowering Cholesterol Levels

Sterol/stanol softgels offer a convenient way to improve cholesterol levels

A research study published this month in the Journal of the Academy of Nutrition and Dietetics demonstrates the effectiveness of a sterol/stanol ester softgel capsule for lowering low-density lipoprotein (LDL) cholesterol in individuals with high cholesterol levels. Plant sterols and stanols occur naturally in plant-based foods and have been shown to decrease cholesterol levels by reducing absorption in the intestinal tract. Pharmavite LLC, makers of Nature Made brand dietary supplements, provided the sterol/stanol esters used in this study in the form of its CholestOff softgel dietary supplement. These study results reinforce the findings of earlier similar research and provide reproducible clinical data that healthcare professionals may find useful in making lifestyle recommendations for their patients.

Throughout this study, all subjects followed a heart-healthy (National Cholesterol Education Program) diet. In a crossover fashion, all subjects received a sterol/stanol softgel for six weeks and a placebo for six weeks with the order of treatments randomly assigned. After taking the sterol/stanol softgels for six weeks, reductions were significant versus the placebo period (P < 0.01) for LDL cholesterol (-4.3%), non-HDL cholesterol (-4.1%) and total cholesterol (-3.5%).

“This is a significant contribution to our understanding of an esterified plant sterol and stanol based dietary supplements’ role in the reduction of cholesterol levels,” said Dr. Kevin Maki of Biofortis, the clinical research arm of Merieux NutriSciences in Chicago. “Our results show that a softgel capsule can be an effective and convenient way to provide plant sterol/stanol esters in a non-food matrix.”

The softgel supplement in this study provided 1.8 grams of esterified plant sterols and stanols in two softgels taken twice daily with meals. This dosage is within the range for which positive changes in cholesterol levels in individuals with high cholesterol have been observed in previous studies. Many individuals consuming a typical Western Diet consume as little as 200 milligrams of plant sterols and stanols each day, a level unlikely to change blood cholesterol levels.

“When Nature Made developed the CholestOff dietary supplement we worked to ensure that the dose provided was consistent with the scientific literature that showed a reducing effect on cholesterol levels,” said Dr. James Brooks, vice president, science and technology, Pharmavite, LLC. “Previously, a study was published showing that the tablet form of CholestOff lowered cholesterol levels significantly. This new study of our softgels adds to the assurance consumers can have using this product.”

The randomized, double-blind, placebo-controlled, crossover study involved 30 non-smoking men and women. Study participants followed the National Cholesterol Education Program (NCEP) Therapeutic Lifestyle Changes (TLC) diet throughout the duration of the study, starting five weeks before the plant sterol/stanol capsules and placebo capsules were administered. The TLC diet is a low saturated fat, low cholesterol diet developed by the National Institutes of Health (NIH) to reduce cholesterol levels to help reduce heart disease risk. Five weeks after starting the TLC diet, subjects were randomly assigned, in a double-blinded manner, to receive either CholestOff softgels or a placebo softgel that contained only soybean oil and medium-chain triglycerides for six weeks each. Throughout the study, subjects were restricted from consuming any dietary supplements as well as plant sterol- and stanol-fortified foods.

These study findings demonstrate the effectiveness of plant sterols and stanols from CholestOff softgel capsules for lowering cholesterol levels as part of the NCEP TLC diet in subjects with high cholesterol. The softgel plant sterol and stanol ester capsules are a convenient and appealing option for individuals managing their cholesterol. For some individuals, this option may help with compliance during long-term use. For more information about Nature Made® CholestOff, please visit NatureMade.com.

Released: 01/22/14

A Skin Cream For Peripheral Neuropathy?

Researchers at Boston Children’s Hospital have developed a skin cream that may relieve a difficult-to-treat form of peripheral neuropathy that is common in people with diabetes and affects millions of people in the US. As reported in this week’s edition of the Proceedings of the National Academy of Sciences, the topical cream tested well in two mouse models of small-fiber neuropathy.

Small-fiber neuropathy—affecting millions of people in the US—causes pain, tingling, and the loss of sensation, usually starting in the feet. Loss of sensation in the feet can increase the chances of ulcers and infections that may lead to amputation, a well-known problem in diabetes. Small-fiber neuropathy also can result from other autoimmune diseases, HIV infection, and chemotherapy treatment. Current treatments consist of analgesics to reduce pain, but these cause unwanted side effects, do not restore sensation, and do not address the underlying cause of the neuropathy.

Because small-fiber neuropathy is known to degenerate the nerve endings of sensory neurons and the loss of a group of factors stimulating nerve growth, Gabriel Corfas, PhD, of the F.M. Kirby Neurobiology Center at Boston Children’s, wondered if replenishing glial cell-derived neurotrophic factor (GDNF) could improve sensory neurons’ health and function.

“Other investigators have been testing the potential use of GDNF in neuropathy, but since GDNF is a large molecule, the only way to get it into the nervous system is through invasive methods such as injections into the spinal cord,” says Corfas.

Thus, rather than using GDNF itself, Corfas and colleagues created a skin cream containing a small-molecule compound, called XIB4035, which enhances GDNF’s effects. “When you use an enhancer, you need less GDNF to activate receptors on the sensory neuron,” Corfas explains. “The receptors are activated for longer, and GDNF’s effects are stronger.”

When mice with small-fiber neuropathy were given the skin cream, they showed improvements in nerve structure and regained sensitivity to heat in their paws as compared with controls receiving an inactive cream. Sensation improved in both diabetic mice and mice that developed small-fiber neuropathy through genetic manipulation. Even mice with advanced disease showed improvements.

“People have been able to treat pain in small-fiber neuropathy, but the treatments cause side effects, and there’s nothing that can help the loss of sensation, which can contribute to people losing limbs,” Corfas says.

The study offers hope for a more targeted, practical treatment for small-fiber neuropathy, says Corfas. “By giving an enhancer, you help only the cells that naturally are exposed to the growth factors and that have the receptors for them,” he says. “Also, because the enhancer is given topically, we are effectively putting it into the neurons, which have their endings in the skin. So there is very little systemic exposure, and we believe there will be far fewer side effects.”

The team is now examining whether the cream has any value for large-fiber neuropathy, which involves motor fibers and is often caused by injury. They also will further explore skin absorption of XIB4035, as well as the effects of systemic delivery.

Kristian Hedstrom, PhD, and Joshua Murtie, PhD, of the F.M. Kirby Neurobiology Center at Boston Children’s are co-first authors of the study.

Funders include the National Institute of Neurological Disorders and Stroke (NINDS; R01 NS35884), the NIH Development Disability Research Center (P30-HD 18655), a National Multiple Sclerosis Society Postdoctoral Fellowship, a Developmental Neurology Training Grant (T32NS007473) and the Technology Development Fund of the Technology and Innovation Development Office (TIDO) at Boston Children’s. For information on business opportunities, read more on TIDO’s website or contact Connie.Caron@childrens.harvard.edu.

Released: 01/22/14

New Nanoparticle Therapy Reduces Damage After Heart Attack

Cour Pharmaceutical Development Company, Inc., a biopharmaceutical company, announced today the publication of new data in Science Translational Medicine that shows the potential of its proprietary therapy, known as Immune Modifying Nanoparticles (IMP), to reduce inflammation and promote tissue repair and regeneration in patients who have suffered a heart attack. More than 750,000 patients suffer from heart attacks and related complications each year.

When animal models were injected with IMPs after a heart attack, the size of the heart lesions were reduced by 50 percent allowing the heart to pump significantly more blood. IMP treatment showed reduced inflammation and promoted regeneration in all models tested.

“This is the first therapy that specifically targets a key driver of the inflammation that occurs after a heart attack,” said Daniel Getts, chief scientific officer at Cour. “There is no other therapy on the horizon that can protect the heart from the aggressive immune cell infiltration that causes so much damage.”

Originally discovered in the laboratory of Professor Nicholas King at the University of Sydney, the particles are proprietary compositions based on poly-lactic-co-glycolic acid, a biocompatible and biodegradable substance already approved by the Food and Drug Administration for use in a range of therapeutics.

“IMP therapy represents a significant step toward the next generation of immune-modulating agents,” said John J. Puisis, CEO of Cour. He added, “Our first priority as a company is to bring IMPs to patients who’ve suffered acute myocardial infarction, where we see a tremendous opportunity to improve clinical outcomes and quality of life.”

The therapy also showed efficacy in numerous other inflammatory models, specifically in West Nile virus, encephalitis, peritonitis, multiple sclerosis, and inflammatory bowel disease—all with the potential to benefit patients suffering from these inflammatory diseases.

Getts and King are corresponding authors on the paper, which was published January 15, 2014 in Science Translational Medicine. For more information, visit courpharma.com.

Released: 01/21/14

Emerson Ecologics Welcomes New Members To Practitioner Advisory Council for Emerson (PACE)

Dr. Corey B. Schuler and Ms. Diana Noland Add Fresh Perspectives in 2014

Emerson Ecologics, LLC, the leading distributor of over 275 professional brands of vitamins, supplements, and natural health products to healthcare practitioners, welcomed Corey B. Schuler, MS, DC, CNS, LN, and Diana Noland, MPH, RD, CCN, to its Practitioner Advisory Council for Emerson (PACE) starting in January. PACE is a team of industry-leading integrative practitioners which helps Emerson to better identify and meet the needs of its professional healthcare customers.

Composed of five members, PACE embodies the diverse perspectives and varied experiences of respected leaders in integrative health. PACE members are all active clinicians and are selected based on their experience in and passion for integrative care and their involvement in furthering their respective professions.

“I am delighted with the addition of Dr. Corey Schuler and Diana Noland to PACE,” says CEO, Andy Greenawalt, “Their combined expertise in clinical nutrition and their strong professional reputations will certainly enhance the service offerings of Emerson Ecologics.”

Dr. Schuler brings his experience as a licensed nutritionist, board-certified nutrition specialist, and a chiropractic physician to PACE. He owns and serves as the clinic director at the Metabolic Treatment Center in Bloomington, MN, which emphasizes functional medicine approaches to mood and hormonal conditions. Dr. Schuler serves on the Medical Advisory Board for Natural Health International (NHI) and on the board of directors for the National Association of Nutrition Professionals (NANP). Dr. Schuler teaches at the School of Applied Clinical Nutrition at New York Chiropractic College and volunteers for the Certification Board of Nutrition Specialists and the American College of Nutrition. He has authored many written works, and he frequently speaks at seminars on integrative medicine.

Ms. Noland brings a unique perspective to PACE as the owner of a private practice called Functional Nutrition Therapy. She is a registered dietician with over 37 years of experience and a board-certified clinical nutritionist. Her specialties include fatty acid metabolism, women’s health, nutritional oral health, and detoxification. Recognized as an expert in the clinical application of functional nutrition therapy, Ms. Noland is a frequent international lecturer to health professionals on various functional medicine and integrative nutrition related topics. She has been a featured speaker for the American Dietetic Association Food and Nutrition Conference & Expo (FNCE) Conference, faculty for the Institute for Functional Medicine, and chair of the Nutrition Advisory Board of the Institute of Functional Medicine (IFM).

Ms. Noland and Dr. Schuler will continue to work with current PACE members, Lise Alschuler, ND, FABNO, Peter Bongiorno, ND, LAc, and Ronald Hoffman, MD, to ensure that the voice of our practitioners is incorporated into Emerson’s strategy.

About Emerson Ecologics

For more than 30 years, Emerson Ecologics, LLC, has been providing practitioners a convenient way to select and purchase from over 275 brands of professional-quality nutritional supplements, vitamins, and natural health products to healthcare practitioners. Customers include naturopathic, chiropractic and medical doctors, licensed acupuncturists, nutritionists, and integrative practitioners, as well as their patients. Emerson Ecologics is also widely recognized for their innovative Emerson Quality Program (EQP). EQP Partners are verified to be compliant with FDA Dietary Supplement current Good Manufacturing Practices (cGMP) standards to help ensure the safety of supplements. Headquartered in Manchester, NH with distribution centers in Virginia and California, Emerson Ecologics is GMP registered by NSF International. For more information, visit emersonecologics.com.

Released: 01/20/14

New Tissue Sample Marking Technology Takes the First Stage of Cancer Detection Beyond the Microscope-Assisted Eye

New software developed by biotechnology specialists PathXL in Belfast, Northern Ireland, provides pathologists with the potential to measure hundreds of cancer characteristics in tissue, improving what can be achieved with the naked eye and conventional microscope–based inspection.

TissueMark software, which works with all the major slide scanning platforms, delves more closely into the structure of tissue samples and renders a tissue heat map that provides far more actionable information about the tissue than can be achieved through manual inspection. The software is precisely tailored for use in the detection of several forms of cancer and in just a few seconds can simultaneously inspect hundreds of image features, compared to the 10 or so available to the trained naked eye. Many of these features involve minute changes in color information and pixel organization that are associated with the cancer cells and tissues.

The system depends on the software’s unrivalled ability to measure and automatically detect tiny incremental changes in image pattern, which are often subtle and not visible to the naked eye. TissueMark can reliably detect these abnormal image patterns and consistently mark the area of cancer against a complex background of normal or non-malignant cells.

TissueMark also overrides one of the most significant problems in manual tissue sample slide marking. While the human eye is good at recognizing broad patterns in images and assessing context, it lacks the ability to precisely measure subtle deviation in colors and pattern. This can lead to diagnostic inconsistency between pathologists who are reviewing the same case and errors in interpretation. It is the consistency and accuracy provided by TissueMark analysis that complements the skills of a pathologist.

Des Speed, CEO of PathXL, said: “TissueMark is a very significant development in digital pathology. In the same way that robotic telescopes, overseen by astronomers, are mapping the universe, digital pathology tools such as TissueMark, overseen by pathologists, are unlocking new insights into the development of disease and potential cures.”

Over an 18-month development period, PathXL worked with five expert pathologists from Queen’s University. The team compared markups from pathologists with the results generated by pre-launch BETA versions of the TissueMark software. Pathologists were also asked to mark up the same tissue samples more than once. Without exception, there were always significant differences in the manually marked-up slides. In a clinical context, these could in some cases have led to false negatives, adding time and duplication to the pathology process. TissueMark examination of the same slides led to consistent, accurate analysis every time. Several recent published studies have found similar inaccuracies in the manual slide marking process and particularly in the assessment of tumor cell numbers, which in modern molecular pathology is extremely important. (See notes to editors).

TissueMark is also extremely rapid and so removes a major potential bottleneck in clinical processes, speeding up diagnosis, eliminating false positives, and freeing pathologists to concentrate on the many important tasks that require specialist human intervention. The software is able to mark as many tissue samples in 10 minutes (in greater detail and with greater accuracy) than an experienced pathologist can mark in a day.

Des Speed added: “Technology in many sectors is enabling us to take a much closer look at the way that the human body operates. At PathXL we specialize in the analysis of tumor tissue and we are proud that TissueMark is enabling better understanding of the mechanisms involved in the progression of certain types of cancer. Our focus is on the optimum partnership between human and computer-based analytical capabilities. This will enable us to provide the pathologist with better tools that bring utility and greater detail and clarity to the analysis of human disease processes.”

Released: 01/16/14

Study Shows Pycnogenol Improves Fitness And Muscle Recovery

Supplementation with renowned pine bark extract shown effective in boosting muscle performance, increasing endurance, and reducing cramping by controlling oxidative stress

New research published in the December 2013 issue of The Journal of Sports Medicine and Physical Fitness shows the effectiveness of a natural supplement in improving overall fitness performance levels and recovery. A clinical trial found that Pycnogenol (pic-noj-en-ol), an antioxidant from French maritime pine tree bark, is effective in improving performance and endurance and reducing muscle cramping and soreness by controlling oxidative stress, an imbalance between antioxidants and pro-oxidants in favor of the latter that can hinder the body’s ability to repair muscle damage.

“Both recreational and serious athletes feel the effects of muscle fatigue, cramping, and soreness from oxidative stress—these factors can impact fitness performance and recovery. Those starting a fitness program, perhaps as part of a New Year resolution to get in shape, may experience pain or soreness that keeps them from getting into their new routine. The findings in this study show that supplementation with Pycnogenol can encourage performance, boost recovery, and help with achieving desired fitness results,” said Steven Lamm, MD, expert and practitioner in health and nutritional medicine.

The Pycnogenol study was based on the Army Physical Fitness Test (APFT) which evaluates physical fitness levels through muscular strength, endurance, and cardiovascular performance. Basic metrics of the APFT were applied in this research, including the number of sit-ups and pushups a participant can complete in two minutes and the time it takes to run two miles.

Conducted in two parts at the Chieti-Pescara University in Pescara, Italy, the study followed 201 subjects ages 32 – 36 years old, who were each tested using either APFT standards or tracked while completing an average 100-minute triathlon.

Each of the clinical trials was divided into two groups: one group of participants that supplemented their daily routine with Pycnogenol and one group that did not. The results of both distinct trials found over four to eight weeks of daily supplementation with Pycnogenol, the participants significantly increased their level of physical fitness and endurance and also reduced training-induced muscular pain and oxidative stress.

Part one of the study consisted of 147 recreational athletes. Each of the 74 participants in the Pycnogenol group (38 males; 36 females) incorporated 100 mg of Pycnogenol into their daily routine; the remaining 73 (36 males; 37 females) did not. All participants were tested on the APFT metrics. Those in the Pycnogenol group showed remarkable improvements in all areas within eight weeks, including:

Two mile run finish time significantly decreased by an average of nearly two minutes
Two minute push-up endurance significantly increased an average of 25 percent
Two minute sit-up endurance significantly increased an average of 15 percent

Part two of the study examined an even higher level of fitness, testing 54 male triathletes. The Pycnogenol group included 32 participants who incorporated 150 mg of Pycnogenol into their daily routine; the control group was comprised of 22 who did not. Participants were tracked over four weeks and evaluated by an average 100-minute triathlon consisting of a .47 mile swim, 12 mile bike ride, and 5k run. Those participants who supplemented with Pycnogenol shed significant time off their splits and reduced oxidative stress levels. Those who supplemented their diet and exercise routine with daily use of Pycnogenol for 30 days:

Significantly increased speed and strength (100 minute triathlon time: 1:40:24 to 1:29:44)
Significantly reduced muscular cramping
Controlled oxidative stress

Study participants were followed between four and eight weeks. Subjects tested in part one of the study completed the APFT five times within one week and subjects in part two completed the triathlon 10 times within 30 days. Throughout the study, participants completed routine blood tests to exclude any risked condition and were evaluated on their level of oxidative stress. At no time was the participant’s activity or working conditions changed, limited, or altered.

“This study provides evidence that daily supplementation of Pycnogenol offers a natural approach to help reduce post-workout muscular pain, increase levels of physical performance, and get you training again sooner,” said Dr. Gianni Belcaro, lead researcher of the study. “Pycnogenol, along with good training and proper nutrition, may help to significantly improve physical fitness and reduce oxidative stress and muscular pain in both in those who exercise recreationally and triathletes.”

This new research adds to the catalog of sports nutrition research on Pycnogenol and reinforces previous findings that the natural extract helps to strengthen blood vessels, alleviate muscular pain, and enhance sports endurance. To review the clinical research and additional information on Pycnogenol, visit Pycnogenol.com.

Released: 01/16/14

Lyme Disease Bacteria and Borrelia Miyamotoi Can Be Reliably Diagnosed by DNA Sequencing, Milford Hospital Pathologist Announced

The nation’s first reliable DNA test for Borrelia burgdorferi and Borrelia miyamotoi, the spirochetes causing Lyme disease and a Lyme disease-like infection in the US is now also available nationwide, according to Sin Hang Lee, MD, a Milford Hospital pathologist and the director of Milford Medical Laboratory (MML) dnalymetest.com.

There are 300,000 newly diagnosed cases of Lyme disease each year, “many of whom can be helped earlier if they were correctly diagnosed to begin appropriate medical treatment,” said Dr. Lee.

The new test is based on the technology described in two published peer-reviewed articles [ajcp.ascpjournals.org/content/133/4/569.long and ncbi.nlm.nih.gov/pmc/articles/PMC2984391/ ], by analyzing a target segment of the bacterial 16S ribosomal RNA gene with Sanger DNA sequencing, the gold standard of all DNA tests, for the final diagnosis, said Dr. Lee.

Currently, “Lyme disease is diagnosed based on symptoms, physical findings (e.g., rash), and the possibility of exposure to infected ticks; laboratory testing is helpful if used correctly and performed with validated methods,” advised the CDC in its guideline for Lyme disease cdc.gov/lyme/.

As to Borrelia miyamotoi infections, the CDC advised the “Diagnosis currently relies on the use of tests to detect DNA of the organism… Blood tests for Lyme disease are unlikely to be helpful in diagnosis of B. miyamotoi infections.” cdc.gov/ticks/miyamotoi.html

“MML is offering the highly sensitive and reliable DNA test for both of the pathogenic spirochetes at $150 for a sample of blood, joint fluid, or spinal fluid, when ordered by a physician. Since many residents in disease-endemic areas also want to know if the ticks removed from their skin bites are infected with Borrelia burgdorferi or Borrelia miyamotoi, MML is offering a service of testing ticks at the cost of $75 per tick with the same technology,” said Dr. Lee.

Released: 01/15/14

Research Confirms Effectiveness Of Cognigram, a New Test For Alzheimer’s Disease

For patients over the age of 50, a routine physical exam at the doctor’s office typically covers a wide spectrum of medical biomarkers with one glaring exception, cognitive health. Unless there have been unusual mental changes or challenges in their daily life, tests of a patient’s attention, memory, or brain processing speed is usually not part of a check-up.

To detect the early, subtle signs of mild cognitive impairment (MCI) which may lead to forms of dementia, including Alzheimer’s disease, there is a need for a standardized test that can alert physicians to a possible cognitive decline. Last week, research from the Florey Institute of Neuroscience and Mental Health in Australia reported that a brief online set of cognitive tests, commercially known as Cognigram, can detect early signs of MCI and Alzheimer’s.

Cognigram has been developed by Cogstate, a leading medical technology company specializing in cognitive assessment and training. Cognigram is available to primary care physicians to provide a dementia test at the point of care in Canada through an exclusive agreement with Merck Canada. More than 580 primary care physicians have registered to use Cognigram and 20 testing centers are now live.

To evaluate the functional health of a human brain, physicians need to observe performance on several key domains. To assess the state of subcortical brain regions including the basal ganglia as well as cortical regions such as the prefrontal and parietal cortices, tests of attention and reaction time are used. Learning and working memory depend on normal functioning of the hippocampus and temporal lobe (for pattern separation) and prefrontal cortex and anterior cingulate (for working memory).

Grouping the attention/reaction and learning/memory domains into composite scores allowed the research team—led by Paul Maruff, PhD, chief science officer of Cogstate—to compare test results with traditional hallmarks of MCI and AD.

“The presence of a relatively greater impairment in cognitive functions dependent on cortical and limbic brain regions (i.e., learning and working memory) with relatively subtle impairment in motor and attention functions is consistent with neuropsychological models of AD. These models emphasize that cognitive impairment characteristic of both prodromal and clinically classified AD is disruption to memory and executive function,” said Dr Maruff.

To test this, they recruited volunteers from the Australian Imaging, Biomarkers, and Lifestyle (AIBL) Study, dividing them into three groups: 653 healthy adults, 107 with amnesic MCI (where the primary symptom is memory loss), and 44 with AD. They were all asked to complete the four tests of the Cogstate brief battery, also known as Cognigram, and the speed and accuracy of the results were recorded.

All of the Cogstate tests use a deck of playing cards as their focus point. No knowledge of any card games is required, patients simply answer a yes/no question about what and when cards are shown to them. For the attention/reaction composite, volunteers completed the Detection task, pressing a certain key on a computer keyboard as soon as a card is turned over, as well as the Identification task, answering yes or no if a card turned over is the color red.

For the learning/working memory composite, two additional tests were used. The One Card Learning task asks, “Have you seen this card before in this task?” To test immediate recall, the One Back test asks if the card displayed is the same as the immediately prior card.

As hypothesized by the research team, the results showed that both the MCI and the AD groups performed significantly worse on both composites than the healthy adults. Also, the AD group’s learning/memory score was significantly lower than the MCI group, demonstrating the presence and progression of the memory decline caused by the disease.

To be a reliable diagnostic tool for physicians, the test battery needs to be able to show consistent results over time. The Cognigram testing was repeated four times in three months and showed statistically similar results across all groups.

The full study can be accessed online at BMC Psychology.

“We are excited about the results of this study,” said Maruff. “The Cogstate brief battery has been found to be sensitive to amyloid-related cognitive change in many trials. This study shows for the first time that a version of the test designed specifically for clinical practice—the Cognigram battery—has excellent sensitivity and specificity to mild cognitive impairment.”

Released: 01/10/14

Ajinomoto Althea Now Offering a Novel Protein Production Platform: Corynex

Ajinomoto Althea, Inc.—a leading contract manufacturing organization providing development and manufacturing services for biotechnology and pharmaceutical companies— announced today its new product offering, Corynex®, to produce secreted, soluble, properly folded proteins from microbial fermentation. In addition, the company announced the successful finalization of the production process for a therapeutic protein primed to enter a Phase I clinical trial. The client was previously using Schizosaccharomyces pombe as an expression system, which garnered disappointing results due to a very low productivity. With a need for a more efficient productivity to support clinical trials, Ajinomoto Althea demonstrated expression with its patented Corynex® platform. Unlike other microbial systems, Corynex® is based on the bacterium Corynebacterium glutamicum, which secretes proteins into the cell culture supernatant in active form with minimal host contaminants.

Ajinomoto Althea was able to effectively scale up production of this therapeutic protein from test tubes to small scale fermentation. A yield of approximately 1 gram per liter was achieved – an exceptional yield due to the difficult nature of the protein. Additionally, column chromatography purification achieved a purity of greater than 98%, which is an excellent purity for a Phase I product.

“We are extremely pleased to have successfully and fully demonstrated the Corynex® platform process here in San Diego. With the addition of Corynex®, we are now offering an even more complete suite of solutions to our customers from process development through clinical manufacturing for a very wide variety of recombinant proteins,” said Kristin DeFife, director of biologics manufacturing at Ajinomoto Althea.

About Ajinomoto Althea, Inc.

Ajinomoto Althea, Inc. is a fully integrated, contract development and manufacturing organization located in San Diego, CA, providing clinical and commercial product development services. Ajinomoto Althea offers cGMP drug product filling in both vials and syringes, and production of microbial-derived recombinant proteins and plasmid DNA. In conjunction with these manufacturing operations, Ajinomoto Althea offers comprehensive development services including: upstream and downstream process development, analytical development, lyophilization cycle, complex formulation, product release and ICH-compliant stability testing. Ajinomoto Althea’s formulation technology platform includes Crystalomics®, a proprietary technology that offers a formulation solution for large molecule products that must be delivered at high concentrations or as sustained release formulations. Ajinomoto Althea also has an innovative and proven recombinant protein expression technology called Corynex®. For more information visit us at www.altheatech.com.

Released: 01/07/14

New Test in Celiac Disease Provides Powerful Tool for Diagnosis and Immune Monitoring

ImmusanT, a company focused on restoring tolerance to gluten and overcoming the need for gluten-free diet in patients with celiac disease, today announced that an article appearing in the February 2014 issue of the journal Clinical & Experimental Immunology features research findings demonstrating that a simple blood test may eventually be used for diagnosing celiac disease and monitoring new therapies. ImmusanT’s chief scientific officer, Bob Anderson, MD, PhD, along with collaborators in Australia, led the study.

The new blood test provides an approach that could lead to more rapid and accurate diagnosis of celiac disease, a condition that can currently only be definitively diagnosed with a small bowel biopsy. The new test could help address an emerging medical problem of inconclusive or self-diagnosed celiac disease in people following a gluten-free diet who may not have the disease.

“This novel diagnostic method for celiac disease required study participants to include gluten in their diets for a mere three days, a stark contrast to the weeks or months of gluten consumption required for a diagnosis using the current standard, bowel biopsy,” said Dr. Anderson.

All study participants, including control patients who did not have celiac disease, ate gluten within three days of taking the blood test. Using the new test, the researchers detected the T cells responsible for celiac disease in 85 percent of the study participants previously known to have the disease. The test was negative in all of the patients on a gluten-free diet who thought gluten was the cause of their digestive symptoms but did not have celiac disease.

“The results from the blood test are highly encouraging and warrant further research and development. Additionally, this is an important step toward a tool that could monitor changes in the small population of circulating T cells responsible for celiac disease when using treatments intended to restore tolerance to gluten, such as Nexvax2, the compound currently being developed by ImmusanT,” Anderson continued.

“There is significant need for highly specific, noninvasive, and easy-to-use diagnostic tools for celiac disease,” said Leslie Williams, president and chief executive officer of ImmusanT.

“The findings from this study are extremely promising and support our ongoing work on a Nexvax2 blood test as a companion diagnostic and monitoring tool. Tests of this quality and simplicity are not available for other immune-mediated diseases, like type-1 diabetes or multiple sclerosis, for which tolerance-inducing treatments are being considered,” Williams said.

ImmusanT is currently developing Nexvax2®, a therapeutic vaccine designed to restore immune tolerance to gluten and allow patients to resume an unrestricted diet.

Visit the Clinical & Experimental Immunology web site to view the entire article.

Released: 01/07/14

Promising New Biomarkers Linked to Early Diagnosis of Breast Cancer

Studies Show New Methods for Early Diagnosis of Breast Cancer and Prediction of Its Spread in Women’s Health Issue of Clinical Chemistry

Two new papers in the “Advancing Women’s Health” issue of Clinical Chemistry, the journal of AACC, show for the first time that measuring the amount of certain protein fragments and microRNAs in a woman’s blood and breast tissue might enable the early diagnosis of breast cancer or prediction of its metastasis, respectively.

Cancer is the second-leading cause of death in both men and women in the US. However, women have a higher chance than men of being diagnosed with cancer before the age of 60 due to breast cancer development. Metastases in breast cancer’s later stages cause the majority of deaths associated with the disease, making early detection crucial to patient survival. Testing for the right biomarkers—biological molecules whose presence indicates a disease—could increase survival rates more than current screening methods such as mammography. Until recently, however, scientists have discovered disappointingly few useful cancer markers.

A team of researchers led by Ye Hu, PhD, of Weill Cornell Medical College of Cornell University, New York, has discovered several promising new biomarkers that could revolutionize the way breast cancer is diagnosed. In their paper, they show that levels of the enzyme carboxypeptidase N (CPN) are higher in breast cancer tissue than in healthy tissues. This enzyme produces six protein fragments, or peptides, that then enter the bloodstream. Hu’s team found that a rise in blood concentrations of these six peptides strongly correlates with increases of CPN, which in turn indicates the presence of breast cancer.

“Our results represent a first demonstration, to our knowledge, that clearly links the proteolytic activity of CPN, particularly at tumor sites, to the cleavage patterns of its catalytic substrates in the blood,” said Hu. “These biomarkers show strong potential for the noninvasive and early diagnosis of breast cancer. We advocate their use … certainly to be detected and identified before metastasis, and perhaps even before the tumor presents with any observable characteristics commonly used in the clinic.”

Another research team headed by Evi Lianidou, PhD, of the University of Athens (Athens, Greece) set out to address the current inability to predict at the time of breast cancer diagnosis whether a patient will experience a relapse or metastasis. Many recent studies have shown that microRNAs (miRNAs)—a type of molecule that turns genes on and off—can play a critical role in the metastasis process. Upon examining this further, Lianidou’s team found that breast cancer patients who experienced quick relapses tended to have high and low levels of the microRNAs miR-21 and miR-205, respectively, in their tumor tissue. The team also discovered a connection between low levels of miR-205 and reduced overall survival.

Testing for these miRNAs or CPN-catalyzed peptides in early or potential breast cancer patients could ensure that women at risk of metastasis receive life-saving preventative treatment.

Released: 01/06/14

Cognitive Rest Aids Concussion Recovery

Limiting texting, homework, online activity may help hasten recovery for teen athletes

A study of 335 teen athletes diagnosed with concussion suggests that patients who comply with cognitive rest limits may recover faster than those who engage in increased cognitive activity, such as texting, reading, and playing video games. The prospective cohort study, conducted at Boston Children’s Hospital and published January 6 in Pediatrics, provides critical data to support physicians’ standard post-concussion advice for restricted cognitive activity.

“We believe this is the first study showing the independent, beneficial effect of limiting cognitive activity on recovery from concussion. Previously, the lack of such data has led to varied practice with regards to implementing cognitive rest, making it even controversial,” says William Meehan, MD, from Boston Children’s Division of Sports Medicine.

Doctors have prescribed cognitive rest for patients diagnosed with a concussion for nearly 10 years; however, evidence supporting the recommendation was scant. Meehan and colleagues designed this study to determine the effect of cognitive activity limits on the duration of post-concussion symptoms.

The researchers enrolled 335 patients with a mean age of 15 years who presented to the Sports Concussion Clinic at Boston Children’s Hospital within three weeks of a concussion between October 2009 and July 2011. They recorded patients’ symptoms using the Post-Concussion Symptom Scale and asked them to complete a Cognitive Activity Scale that recorded their average level of cognitive activity at each visit.

The 5-point scale ranged from complete cognitive rest—defined as no reading, homework, text messaging, video game playing, and online activities—to full cognitive activity, or no limits at all. Cognitive activity levels were divided into quartiles.

Statistical analysis showed that patients who engaged in the highest level of cognitive activity required the most time for concussion symptoms to resolve.

The findings demonstrate the importance of academic accommodations, such as modified assignments or extra time for schoolwork, for students diagnosed with a concussion.

Although cognitive rest facilitated recovery from concussion, the results suggest balanced activity. Patients who engaged in the three lower cognitive activity quartiles—complete rest, minimal activity (no reading or homework, less than five text messages and less than 20 minutes of online activity and video games per day) and moderate activity (reading less than 10 pages, less than 20 text messages and less than one hour combined of homework, online activity and video games per day)—required about the same length of time to recover.

“These findings indicate that complete abstinence from cognitive activity may be unnecessary,” says Meehan. “Our findings suggest that while vigorous cognitive exertion is detrimental to recovery, more moderate levels of cognitive exertion do not seem to prolong recovery substantially. Thus, we recommend a period of near full cognitive rest acutely after injury, approximately 3-5 days, followed by a gradual return to sub-symptom levels of cognitive activity.”

To learn more about how to help students return to school after a concussion, click here.

Click here to download Boston Children’s Concussion Prevention Guide.