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Past News Items - Jan 2015

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In the News

New Biological Evidence Reveals Link Between Brain Inflammation and Major Depression

New Approach to Delay Alzheimer's Dementia Onset to be Tested

CRN Releases Science-based Guidelines on Iodine in Multivitamin/Mineral Supplements for Pregnancy and Lactation

Protein-Based Therapy Shows Promise Against Resistant Leukemia

Ground-Breaking PTSD Treatment Promises Fast Relief for Veterans

Study Shows Daily Use of Pycnogenol Can Improve Memory, Focus, Decision-Making, and Mood

New Data Published In European Heart Journal Found HDL3 Cholesterol Subclass To Be Superior In Predicting Cardiovascular Disease Death

First Evidence of Potential Efficacy of Tau Aggregation Inhibitor Therapy in Alzheimer's Disease

Emerson Ecologics Launches 2015 Emerson Grant Program

Can Waiting Rooms Make You Sicker?

Albert Einstein College of Medicine Announced as the New Coordinating Center for National Research Network

Botanical Adulterants Program Introduces "Laboratory Guidance Documents" Series to Help Industry Detect Potential Herb Adulteration

GliaCure Completes Phase 1a Clinical Trial in Alzheimer's Disease

Study of Castle Biosciences’ Skin Melanoma Gene Test Published in Clinical Cancer Research

Released: 01/29/15

New Biological Evidence Reveals Link Between Brain Inflammation and Major Depression

A new study by the Centre for Addiction and Mental Health (CAMH) found that the measure of brain inflammation in people who were experiencing clinical depression was increased by 30 percent. The findings, published yesterday in JAMA Psychiatry, have important implications for developing new treatments for depression.

"This finding provides the most compelling evidence to date of brain inflammation during a major depressive episode," says senior author Dr. Jeffrey Meyer of CAMH's Campbell Family Mental Health Research Institute. "Previous studies have looked at markers of inflammation in blood, but this is the first definitive evidence found in the brain." 

Specifically, Dr. Meyer's research team was able to measure the activation of immune cells, known as microglia, that play a key role in the brain's inflammatory response.

To investigate whether brain inflammation was increased in people during clinical depression, Dr. Meyer and his team conducted brain scans on 20 patients with depression but who were otherwise healthy and 20 healthy control participants using a brain imaging technique called positron emission tomography (PET).  Results showed a significant elevation of brain inflammation in participants with depression. Rates of inflammation were also highest among those with the most severe depression.

Although the process of inflammation is one way that the brain protects itself—similar to the inflammation of a sprained ankle—too much inflammation may not be helpful and can be damaging. A growing body of evidence suggests the role of inflammation in generating the symptoms of a major depressive episode such as low mood, loss of appetite, and inability to sleep. But what was previously unclear was whether inflammation played a role in clinical depression independent of any other physical illness.

"This discovery has important implications for developing new treatments for a significant group of people who suffer from depression," says Dr. Meyer, who also holds a Canada Research Chair in the neurochemistry of major depression. "It provides a potential new target to either reverse the brain inflammation or shift to a more positive repair role, with the idea that it would alleviate symptoms."

The drive to uncover new ways to target and treat depression is fueled by the reality that more than half of people with major depression do not respond to antidepressant treatments and 4 percent of the general population is in the midst of a clinical episode. Current treatments do not target inflammation, and treating depression with anti-inflammatories is one avenue for future research, Dr. Meyer says.

"Depression is a complex illness and we know that it takes more than one biological change to tip someone into an episode," says Dr. Meyer. "But we now believe that inflammation in the brain is one of these changes and that's an important step forward."  

First author of the study was post-doctoral research fellow Dr. Elaine Setiawan. This research was supported by the Canadian Institutes of Health Research, the Brain and Behavior Research Foundation, the Canada Foundation for Innovation, and the Ministry of Research and Innovation. 

Source: Centre for Addiction and Mental Health, camh.net


Released: 01/29/15

New Approach to Delay Alzheimer's Dementia Onset to be Tested

The Alzheimer's Drug Discovery Foundation (ADDF) announced yesterday a $900,000 grant to AgeneBio, a pharmaceutical company developing innovative therapies for neurologic and psychiatric diseases. The grant will support the initiation of an FDA-registered Phase 3 clinical trial of AGB101, a new therapeutic treatment for amnestic mild cognitive impairment (aMCI). aMCI is a condition in which memory is worse than to be expected for a person's age and is considered the pre-dementia stage of Alzheimer's disease. This is the second grant that the ADDF has made to AgeneBio.

AGB101 is a proprietary formulation of low-dose levetiracetam, given to patients at approximately one-fifteenth of the dose most commonly prescribed for epilepsy. This therapeutic has been commercialized for more than a decade and offers a well-characterized safety profile at 15 times the expected dose for AGB101. AgeneBio expects to initiate the AGB101 Phase 3 clinical program in the second half of 2015.

AGB101 is the first and only treatment to target hippocampal hyperactivity, a condition characteristic of the aMCI stage of Alzheimer's disease. The Phase 3 trial will build on studies in both animal models and patients with aMCI that have demonstrated the importance of reducing hippocampal hyperactivity to restore the brain function necessary to maintain cognitive function and memory.

aMCI is believed to affect between 10 and 20 percent of individuals 65 and older. There is currently no FDA-approved therapy for patients in this pre-dementia stage of Alzheimer's disease, representing an enormous unmet clinical need.

"The ADDF is thrilled to support AgeneBio to advance the clinical development of this drug candidate for the benefit of aMCI patients," said the ADDF's founding executive director and chief science officer Howard Fillit, MD. "This treatment has the potential to alter the course of Alzheimer's disease, restore normal brain function, and preserve memory and cognitive abilities."

"We are extremely grateful to the ADDF for its continued support of our drug development program," said AgeneBio's CEO Jerry McLaughlin. "This additional grant is a strong endorsement of our clinical program, and we look forward to working with ADDF as our research progresses."

AgeneBio's portfolio of drug discovery work is based on the research of its founder, Michela Gallagher, PhD, Krieger-Eisenhower professor of psychological and brain sciences and principal investigator of the Neurogenetics and Behavior Center at Johns Hopkins University.


Source: Alzheimer's Drug Discovery Foundation, alzdiscovery.org


Released: 01/28/15

CRN Releases Science-based Guidelines on Iodine in Multivitamin/Mineral Supplements for Pregnancy and Lactation

Dietary supplement manufacturers should include a daily serving of at least 150 mcg of iodine in all multivitamin/mineral supplements intended for pregnant and lactating women in the U.S., the Council for Responsible Nutrition (CRN) advises in guidelines for industry released today. CRN, the leading trade association for the dietary supplement and functional food industry, developed these guidelines in response to recommendations from authoritative medical organizations, including the American Academy of Pediatrics, the Endocrine Society, and the American Thyroid Association, that pregnant and lactating women receive a daily multivitamin/mineral supplement that contains 150 mcg of iodine.

"Scientific evidence shows that, similar to folic acid, adequate iodine is critical early in pregnancy when the fetal brain is growing rapidly," said Duffy MacKay, ND, senior vice-president, scientific and regulatory affairs, CRN. "Currently, many US women of childbearing age get insufficient dietary iodine, putting their children at risk for decreased cognitive function. CRN's guidelines call on manufacturers of multivitamin/mineral supplements for pregnant and lactating women in the US to provide the scientifically-backed amount of iodine that this population needs."

According to CRN's guidelines, any safe and suitable iodine-containing dietary ingredient may be used as the source of iodine when used in accordance with Good Manufacturing Practice (GMP) regulations for dietary supplements, which will ensure that the product consistently meets label claims.

"We commend the Council for Responsible Nutrition for stressing the importance of iodine for pregnant and lactating women in order to ensure normal brain development of the fetus and baby," said Robert C. Smallridge, MD, president, American Thyroid Association. "Our association strongly concurs that pregnant and lactating women should get 150 mcg of iodine daily from their multivitamin/mineral supplement."  

CRN's recommended guidelines, "Iodine Quantity in Multivitamin/Mineral Supplements
for Pregnancy and Lactation," are available on the association's
website. CRN recommends that dietary supplement companies comply within twelve months.

CRN's iodine guidelines are the latest in a series of proactive, science-based guidelines that the association has developed as part of its self-regulatory initiatives. CRN also has recommended guidelines for caffeine-containing dietary supplements and for labeling of protein in dietary supplements and functional food, as well as best practices for enzyme dietary supplement products and safety considerations for dosage recommendations and labeling.


Released: 01/25/15

Protein-Based Therapy Shows Promise Against Resistant Leukemia

Resistance of leukemia cells to contemporary chemotherapy is one of the most formidable obstacles to treating acute lymphoblastic leukemia (ALL), the most common form of childhood cancer. Now, researchers at Children’s Hospital Los Angeles (CHLA) have designed and developed a new protein-based therapy they believe will prove highly effective against drug-resistant leukemia cells. It may also amplify the potency of standard treatment options such as chemotherapy and radiation therapy.

Their work, published online January 26 by the Journal of Clinical Investigation, demonstrated the efficacy and safety of the new fusion protein in mouse models of aggressive human leukemia using leukemia cells taken directly from patients with ALL.

Occurring at an annual rate of 35 to 40 cases per million people in the US, ALL represents approximately 25 percent of cancer diagnoses among children younger than the age of 15. Historically, ALL had a high mortality rate; nearly 80 percent of children who developed the disease did not survive long term. Today, those numbers have been reversed, with almost 80 percent of children affected by ALL achieving long-term survival.

“That’s great news, unless your child is one of the 20 percent,” said the study’s principal investigator, Fatih M. Uckun, MD, PhD, of the Children’s Center for Cancer and Blood Disease at CHLA and the Norris Comprehensive Cancer Center of the University of Southern California (USC). “Despite advances in available therapies, unmet and urgent needs remain in the fight against leukemia. We still have children with disease that our drugs can’t help enough. And for patients who relapse, their chances of long-term survival are less than 20 percent. We’ve got to do better.”

TNF-related apoptosis-inducing ligand (TRAIL) is a protein functioning as a ligand that induces apoptosis, or cell death. Produced by the immune system cells, it has the potential to cause apoptosis in tumor cells by binding to two so-called “death receptors,” also known as TRAIL-receptor 1 and TRAIL-receptor 2.

“TRAIL is a naturally occurring part of the body’s immune system that kills cancer cells without toxicity to normal cells. However, earlier clinical trials using TRAIL as a potential anti-cancer medicine candidate have not been successful, largely because of its propensity to bind, not only to cancer cells, but also to ‘decoy’ receptors,” explained Uckun, who is also a professor of pediatrics at Keck School of Medicine of USC.

Uckun and collaborators discovered a previously unknown protein—CD19-Ligand—a natural ligand of human CD19, which is expressed by almost all ALL cells. They hypothesized that fusing it by genetic bioengineering to the portion of TRAIL (known as sTRAIL) that can kill cancer cells would produce a powerful weapon against leukemia cells. Unlike chemotherapy drugs, this precision medicine candidate would seek out, bind, and destroy only leukemia cells carrying CD19 as the target docking site.

They successfully accomplished this unique assembly of the two proteins in a single “fusion protein” and named this protein therapeutic candidate “CD19L-sTRAIL.” In their study, Uckun and collaborators have demonstrated that their engineering converted sTRAIL into a much more potent “membrane-anchored” form that is capable of triggering apoptosis, even in the most aggressive and therapy-resistant form of human leukemia cells.

“Due to its ability to anchor to the surface of cancer cells via CD19, CD19L-sTRAIL was 100,000-fold more potent than sTRAIL, and consistently killed more than 99 percent of aggressive leukemia cells taken directly from children with ALL—not only in the test tube, but also in mice,” said Uckun. Administering only two or three doses of CD19L-sTRAIL significantly improved the survival outcome of mice challenged with an otherwise invariably fatal dose of human leukemia cells, without side effects. Its therapeutic potency in mice was superior to that of standard chemotherapy combinations as well as radiation therapy.

“The biggest challenge is to cure patients who experience a recurrence of their cancer, despite intensive chemotherapy,” Uckun concluded. “We are hopeful that the knowledge gained from this study will open a new range of effective treatment opportunities for children with recurrent leukemia.”

Additional contributors include Dorothea E. Myers, Zahide Ozer, Osmond J. D’Cruz, and Hong Ma of the Children’s Center for Cancer and Blood Diseases and Children’s Hospital Los Angeles; Sanjive Qazi of CHLA and Gustavus Adolphus College, St. Paul, MN; and Rebecca Rose of Rose Pathology Services, St. Paul. The project was supported by a 2011 V-Foundation Translational Research Award and in part by DHHS grants R21-CA-164098, U01-CA-151837, and R01-CA-154471 from the National Cancer Institute, part of the National Institutes of Health.


Source: Children’s Hospital Los AngelesCHLA.org
Follow the blog at researchlablog.org


Released: 01/23/15

Ground-Breaking PTSD Treatment Promises Fast Relief for Veterans

Local neuropsychologist George Lindenfeld, PhD, has spearheaded the development of a new, remarkably effective treatment for PTSD and is seeking select veterans for a future study that will provide treatment for their symptoms and include fMRI imaging to record brain changes.

Dr. Lindenfeld has recently retired from private practice to pursue this research, and has relocated to Sarasota from Asheville, NC. He has more than 45 years of clinical experience specializing in the treatment of trauma, specifically post-traumatic stress disorder.

His new treatment is based on a unique application of the latest discoveries in neuroscience and memory reconsolidation. Called RESET Therapy (Reconsolidation Enhancement by Stimulation of Emotional Triggers), relief is often obtained in just one to two treatment sessions. RESET Therapy uses specific therapy techniques combined with acoustical neuromodulation, provided by a device from Insight NeuroSystems, to "reset" fear circuits in the brain back to pre-trauma levels.

This treatment is especially important, according to Dr. Lindenfeld, because current treatment methods are largely ineffective. Charles Marmar, chairman of psychiatry at NYU Langone Medical Center and director of the NYU Veterans Center, was recently quoted in the New York Times, saying, "A significant number of veterans are going to have PTSD for a lifetime unless we do something radically different."

Dr. Lindenfeld has personally treated well over 100 patients with this procedure using RESET therapy. Worldwide, many thousands of trauma patients have benefited from this same method. In his practice, Lindenfeld has achieved remission—complete relief of PTSD symptoms in every case—even with PTSD symptoms dating back decades to the Vietnam War.

This safe, simple therapy procedure has also been used in 18 countries over the last 10 years for hard-to-treat conditions like depression, addiction, and chronic pain.

Dr. Lindenfeld is currently seeking to present his findings to organizations interested in veteran and civilian trauma recovery. He is the author of a paper scheduled for publication by the International Society of Neurofeedback Research (ISNR) in the Spring of 2015, entitled “Resetting the Fear Switch in PTSD: A Novel Treatment Using Acoustical Neuromodulation to Modify Memory Reconsolidation,” and of the forthcoming book I Fix PTSD & So Can You—A Healers Guide.

Source: George Lindenfeld, PhD


Released: 01/22/15

Study Shows Daily Use of Pycnogenol Can Improve Memory, Focus, Decision-Making, and Mood

New research delivers exciting news for those seeking natural ways to boost memory and mental performance. A study recently published in the Journal of Neurosurgical Sciences shows daily use of pycnogenol (pic-noj-en-all), a  natural plant extract from French maritime pine tree bark, may help improve attention span, memory, decision-making—including executive-level performance—and overall cognitive function.

"This study finds pycnogenol to be a safe and effective natural option to improve day-to-day cognitive function, essentially serving as 'brain food' for executives, entrepreneurs, and those who want help sharpening their decision-making. What is unique about this study is that it observes how pycnogenol can positively impact mood, as participants reported feeling less anxiety and a stronger sense of content. That may be connected back to the mental performance boost and demonstrates the effects of dramatic reduction of oxidative stress," said physician and nutritional medicine expert Dr. Fred Pescatore.

According to the National Center for Biotechnology Information, the average American's attention span has reduced from 12 seconds (reported in 2000) to 8 seconds, which can hurt productivity and quality of work produced.

The peer-reviewed study conducted at Chieti-Pescara University in Italy and published in the December 2014 Journal of Neurosurgical Sciences, included 59 participants between ages 35 and 55, all of whom were generally fit and followed a healthy lifestyle.

In the study, 30 participants supplemented pycnogenol 50mg/three times daily in combination with a controlled health plan; 29 participants in the control group followed the controlled health plan alone. The health plan involved regular sleep, balanced meals, and daily exercise. While there is no single solution to improved cognitive function, lifestyle patterns and daily exercise routines have shown to increase attention span and improve mood. 

In the study, after 12 weeks of daily supplementation with pycnogenol, results were also shown to:

>>Significantly improve mood (16 percent increase pycnogenol / -2.1 percent control)

>>Measurably boost mental performance (8.9 percent increase pycnogenol / 3.1 percent control)

>>Advance sustained attention (13.4 percent increase) and memory (3.6 percent increase)

>>Dramatically reduce oxidative stress (30 percent decrease pycnogenol)

"This study completes a number of research observations indicating that pycnogenol can naturally help improve some aspects of cognitive functions throughout life. Multiple studies have been conducted using pycnogenol and showing its positive effects in managing and improving some attention parameters in children with ADHD, in improving results of specific cognitive test in students, and in improving several aspects of cognitive functions in adults over 60," said Dr. Gianni Belcaro, lead researcher of the study. "These latest findings are supported by decades of research on pycnogenol's ability to naturally regulate oxidative stress levels (that may significantly affect some cognitive functions) and confirm the positive impact on overall cognitive function."

Results of the study were measured using a self-administered visual analogue scale (VASL), national adult reading test (NART), special recognition memory (SRM), and Cambridge neuropsychological test to evaluate simple cognitive functions and levels of oxidative stress.

"Participants who supplemented daily with pycnogenol demonstrated stronger performance in daily mental tasks such as dealing with money, managing people, and coping with stress. Those are mental performance benefits that can be felt from the home to the office and even in the classroom," said Dr. Pescatore.


Source: Pycnogenol, pycnogenol.com


Released: 01/21/15

New Data Published In European Heart Journal Found HDL3 Cholesterol Subclass To Be Superior In Predicting Cardiovascular Disease Death

Data analyzed from two complementary prospective cohort studies demonstrated the benefit of measuring subclasses of high-density lipoprotein cholesterol (HDL-C). In the most recent issue of the European Heart Journal, investigators published new data directly measuring HDL-C – the "good" cholesterol in the body – and the subclasses of this specific lipoprotein, in patients with established coronary heart disease (CHD). Recent clinical trials on HDL-C have failed to show a benefit of certain drugs that raise total HDL-C on cardiovascular risk. Other studies have suggested that the HDL3 subfraction is more strongly associated with lower CHD risk. The present study used the Vertical Auto Profile (VAP) Lipid Panel—a commercially available cholesterol test that uses density gradient ultracentrification and directly measures lipoproteins—to directly measure the subclasses of HDL, and more specifically the role that HDL3 cholesterol (HDL3-C) plays in predicting hard clinical events, namely myocardial infarction (MI) and death. The conclusion of this study analysis was that in secondary prevention, increased risk for long-term hard clinical events is associated with low HDL3-C but not HDL2-C or total HDL-C, highlighting the value of sub classifying HDL-C. There was a >50 percent higher risk for people with the lowest HDL3-C levels. Researchers from the Lipoprotein Investigators Collaborative (LIC) examined data from two complementary, prospective cohorts: the Translational Research Investigating Underlying disparities in acute Myocardial infarction Patient's Health status (TRIUMPH) study and the Intermountain Heart Collaborative Study (IHCS).

"For decades, the de facto standard for HDL assessment has been its total cholesterol content. Low HDL cholesterol levels have been linked to CHD, the leading cause of death in the United States," lead investigator Dr. Seth S. Martin of Johns Hopkins Ciccarone Center for the Prevention of Heart Disease in Baltimore, Maryland, said. "However, what has become apparent is that total HDL cholesterol concentration is a remarkably simple measure for a staggeringly complex lipoprotein. Our collaborative study highlights the information that can be gained by moving to a higher-resolution measure."

To better understand the associations of HDL subclasses, researchers analyzed data from the TRIUMPH and IHCS studies of secondary prevention patients in whom HDL-C was sub classified by a common method of ultracentrifugation. The TRIUMPH study enrolled 2,465 acute MI patients, and the IHCS study enrolled 2,414 patients who underwent coronary angiography. TRIUMPH participants were included on the basis of acute MI and IHCS participants on the basis of coronary angiography for MI, unstable angina or stable angina. The participants were followed out to 5 years and the researchers adjusted analyses for a robust set of potential confounders.

According to researchers, this is the largest and most completely adjusted observational study seeking to define the independent associations of HDL-C and its subclasses with clinical outcomes in patients with established CHD. Additionally, in CHD patients, it is also the first to examine mortality as an endpoint in relation to HDL2-C versus HDL3-C.

"While these results substantially advance our understanding of the underlying biologic and epidemiologic relationships in secondary prevention, they fall short of clarifying the uncertainty and complexity surrounding HDL-based therapeutic strategies," said senior investigator on the study, Dr. Steven R. Jones of Johns Hopkins Ciccarone Center for the Prevention of Heart Disease.  

Findings were previously published in the June 30 online edition of the European Heart Journal.

Atherotech Diagnostics Lab, a leading clinical reference laboratory specializing in cardiometabolic testing and disease management solutions, is the maker of the VAP+ Lipid Panel. For more information on Atherotech or the VAP+ Lipid Panel, visit www.Atherotech.com


Released: 01/21/15

First Evidence of Potential Efficacy of Tau Aggregation Inhibitor Therapy in Alzheimer's Disease

The Journal of Alzheimer's Disease has published today the results of the first clinical trial of a Tau Aggregation Inhibitor (TAI) in Alzheimer's disease (AD). This Phase II clinical trial, conducted by TauRx Therapeutics Ltd (a Singapore incorporated spinout from the University of Aberdeen), provided the basis and rationale for subsequent Phase III clinical trials of a TAI in AD currently in progress.

The double-blind dose-finding Phase II clinical trial involved 321 patients in 16 clinical research centres in the UK and one centre in Singapore and tested three doses of the drug. The study met its predefined primary efficacy endpoint at 24 weeks on the standard scale most commonly used to measure cognitive decline in clinical trials (ADAS-cog) at the 138 mg / day dose. The primary result was also supported by benefit on two other clinical scales. The effect sizes seen were statistically significant and clinically meaningful in moderate subjects at 24 weeks. The clinical results were also supported by brain scan evidence of arrest of decline over the same period in mild subjects at the same dose. The beneficial effect was sustained to 50 weeks in both mild and moderate subjects at this dose, with 90 percent reduction in the rate of cognitive decline overall.

This is the first ever clinical trial which has attempted to target directly the hallmark neurofibrillary tangle pathology of AD. Tangles were originally discovered by Alois Alzheimer in 1906 and this discovery gave the disease its name. Tangles were found to be composed of abnormal filaments largely made up of a short fragment of the protein Tau in 1988 by Professor Claude Wischik (co-founder of TauRx Therapeutics Ltd) and colleagues in Cambridge, UK. The spread and density of tangles in the brain are known to be highly correlated with the clinical severity of dementia. They are also correlated with the extent of abnormal aggregation of Tau protein and loss of neuronal function seen on brain scans in those brain regions where tangles typically form. Wischik and colleagues went on to report in 1996 that the chemical substance methylthioninium (MT), used in medicine for the last 100 years, dissolves tangle filaments isolated from the human brain by selectively blocking a critical step in the process required to form the rogue filaments.

The encouraging efficacy signals seen in the TauRx trial at the minimum effective dose of 138 mg / day were first announced in a preliminary form at the Alzheimer's Association International Conference on Alzheimer's Disease in Chicago, USA, in July 2008. However, the surprising observation that the top dose of 228 mg /day had reduced efficacy has taken TauRx scientists a further 4 years to unravel. The results of these studies have also been reported in parallel in the Journal of Pharmacology and Experimental Therapeutics.

The form of MT that has been used in medicine for the last 100 years (a chloride salt of the oxidised MT form of the molecule, denoted MTC, and commonly known as "methylene blue") is poorly tolerated without food, so taking it with food has been recommended traditionally. However, TauRx scientists discovered that MTC suffers from dose-dependent impairment in absorption when taken with food. This is due to the fact that the oxidised MT form needs to be actively converted to the reduced LMT form in the gut before it can be absorbed as LMT. In other words, MTC is a pro-drug for LMT, and food interferes with the conversion and absorption process. Since MTC was given with food in the Phase II trial to maximise tolerability for patients, only 109 mg / day of the intended 228 mg dose was available for absorption. Therefore, the minimum effective dose of 138 mg / day identified in the trial was simply the highest available dose tested.

In order to go forward into Phase III testing, TauRx scientists have developed an entirely new form of the molecule which keeps MT in the LMT form and therefore permits it to be absorbed directly without need for active conversion in the gut. This new form is denoted LMTX for the present and is better absorbed and tolerated than MTC. This has enabled Phase III trials to test whether an even higher level of efficacy can be achieved without significant loss of tolerability and safety. The ongoing trials are testing MT delivered as LMTX in the dosage range of 150 – 250 mg / day.

The full results now published in the Journal of Alzheimer's Disease were previously available only as reports supporting regulatory filings for global confirmatory Phase III clinical trials in 22 countries. These trials are now fully recruited and the first results are expected in the first half of 2016. If the Phase III clinical trials confirm a level of efficacy and safety similar to that seen in the Phase II trial reported in the Journal of Alzheimer's Disease, a treatment targeting the Tau aggregation pathology of AD could be on the market as early as 2017. 


Released: 01/20/15

Emerson Ecologics Launches 2015 Emerson Grant Program

Emerson Ecologics, LLC, the leading distributor of more than 275 brands of professional-quality vitamins, supplements, prescription medications, and natural health products, has announced that it is now accepting applications for The Emerson Grant. The Emerson Grant program supports the work of practitioners and promotes integrative medicine in the United States.


In April 2015, Emerson Ecologics will award grants totaling $25,000 to support projects and initiatives designed to improve, expand, or support the practice of integrative medicine. The Emerson Grant is a competitive, discretionary award ranging from $500 to $10,000. Projects may include legislative efforts, public awareness campaigns, or enhancements to education or clinical training, but all projects are welcome.


The New York Association of Naturopathic Physicians, a winner of The Emerson Grant in 2014, used its grant to help further their efforts toward licensure for naturopathic doctors in New York. NYANP president Rick Brinkman, ND, said, "The Emerson grant was a blessing to the NYANP legislative efforts to gain licensure for NDs in New York. The grant revitalized our efforts at a crucial time when financial support was essential to forward progress. Thank you Emerson!"


Emerson Ecologics is dedicated to the continued growth and awareness of integrative healthcare and wellness. The company recognizes that hundreds of volunteer-driven organizations work tirelessly to support integrative medicine. As the premier resource of products and services for the integrative healthcare community, Emerson wants to help these organizations achieve their vision. For more details on The Emerson Grant program or to download an application, visit emersonecologics.com/grant.



Source: Emerson Ecologics, LLC


Released: 01/14/15

Can Waiting Rooms Make You Sicker?

As the flu continues to sweep the nation, hitting earlier and harder compared to last year, more doctor’s offices are advising their patients to describe their symptoms over the phone or Internet, instead of coming in for an exam. “Healthcare workers need a strategic action plan that addresses the tension and balance many clinicians are faced with between patients coming in for treatment or staying home.”

The reason? Too many patients are arriving at the doctor’s office at their most contagious state, putting other patients in the waiting room, and the healthcare workers who care for them, at greater risk of infection.

The approach, a healthcare trend called telemedicine, is typically used by some doctors to help treat patients no matter their location – abroad, out-of-state, or just unavailable for an in-person appointment. But with so many patients wanting to see the doctor this flu season, physician offices have been slammed, making telemedicine a next best, and cautious, option for some.

With the flu now widespread in 46 states, and the peak still expected to hit in February, it’s time for healthcare workers to fight this year’s feisty flu from all angles, including right in the waiting room. One study sites that Americans wait an average of 24 minutes to see their physicians nationwide. So what steps can healthcare providers take to ensure an excellent patient care experience right in the waiting room?

“While telemedicine may be an option for some doctor’s offices, it is critical that all clinics, including urgent care settings across the country, create safer waiting rooms to help protect against the spread of the influenza virus,” says Martie Moore, chief nursing officer for leading healthcare supplier Medline Industries, Inc. “Healthcare workers need a strategic action plan that addresses the tension and balance many clinicians are faced with between patients coming in for treatment or staying home.”

Clinics and doctor’s offices can follow simple steps to make sure those coming into their waiting rooms are protected so they can continue to provide excellent, in-person patient care. Moore advises healthcare workers follow these precautions to help keep waiting rooms germ-free:

1.     Make hand sanitizer, such as Sterillium Comfort Gel, accessible in several high-traffic spots. The product kills 99.999 percent of germs in 15 seconds without water, and is effective against a broad range of pathogens.

2.     Offer Biomask, an antiviral face mask to patients, in addition to healthcare workers. The mask, also available to consumers at many retailers as the CURAD antiviral face mask, is the industry’s first antiviral face mask. It uses three powerful yet safe active ingredients – zinc, copper and citric acid – to inactivate 99.99 percent of 15 different laboratory-tested subtypes of Influenza A and B, including both seasonal H3N2 and pandemic H1N1. It is the first-ever face mask that actually inactivates flu viruses upon five minutes of contact, helping protect the wearer against flu viruses.

3.     Wipe down all high-contact surfaces. Help reduce the spread of germs with products like Micro-Kill One wipes, which can be used on countertops and tables. These wipes can kill certain infectious microorganisms including Influenza A2, within one minute.

4.     As much as possible, review containment plans and distance patients with symptoms from others to help mitigate exposure potential. People with the flu can spread it to others, up to six feet away, according to the Centers for Disease Control and Prevention (CDC).

5.     Remember to always follow hand hygiene compliance standards.

For more practical tips to prepare healthcare workers for this year’s influenza season, read this blog post from Moore at mkt.medline.com/clinical-blog/acute-care/dont-forget-the-flu/.

Learn more about Medline’s infection protection products at medline.com/category/Infection-Control/cat1470085


Released: 01/13/15

Albert Einstein College of Medicine Announced as the New Coordinating Center for National Research Network

The Bravewell Collaborative announced today that Albert Einstein College of Medicine of Yeshiva University will lead the Bravewell Integrative Medicine Research Network (BraveNet), a practice-based consortium of 14 integrative medicine centers in the United States. As the coordinating center for BraveNet, Einstein will manage the network’s Patients Receiving Integrative Medicine Interventions Effectiveness Registry (PRIMIER), the first patient registry for integrative medicine, which combines complementary/alternative and conventional medical practices.

“BraveNet has helped unite the medical community and establish a strong future for evidence-based research in integrative healthcare,” said Christy Mack, president of The Bravewell Collaborative. “Einstein has a long-standing commitment to integrative medicine and is well-situated to ensure the continued success of PRIMIER.”

Building the Network
The Bravewell Collaborative established BraveNet in 2007 as the nation’s first practice-based research network for integrative medicine to study the benefits of an integrative approach to healthcare. As part of this mission, BraveNet created PRIMIER, a data registry project intended to uniformly collect patient-reported outcomes, provider input, and extracted electronic health record data into a large dataset. This dataset can be used for quality improvement, evidence-based research, and determination of best practices.

M. Diane McKee, MD, MS, co-director of research and attending physician in the department of family and social medicine at Einstein and Montefiore Medical Center, noted the value of registry databases such as PRIMIER: “Registries are unique in that they allow researchers to examine patient subsets to precisely determine how individual patients benefit from each intervention. The process is cost-effective and allows researchers to gather evidence on a much larger scale than in a typical clinical trial.”

The PRIMIER registry provides foundational knowledge on how integrative medicine is being used in real-world settings. This knowledge will ultimately inform decision-making in clinical settings and serve as the basis for future clinical trials. The hope is that PRIMIER will expand over time, including more public as well as private integrative medicine centers, to create a national registry that will help improve the health and well-being of patients and provide a framework for discovering best practices in integrative medicine.

“Over the past 12 years, The Bravewell Collaborative has made an unparalleled commitment to furthering the field of integrative medicine,” said Benjamin Kligler, MD, MPH, associate professor of clinical family and social medicine at Einstein and chair of the BraveNet executive committee. “I’m excited for the opportunity to continue this work and co-lead such an important program. The network and its research endeavors will continue to help shape the future of healthcare.”

Einstein Informatics and Research Resources
Under the leadership of Dr. McKee, Dr. Kligler, and Paul Marantz, MD, MPH, associate dean for clinical research education at Einstein, BraveNet at Einstein will be a collaboration between two productive and established components of Einstein research infrastructure: the Block Institute for Clinical and Translational Research at Einstein and Montefiore (ICTR) and the department of family and social medicine’s division of research, home of Einstein’s primary care practice-based research network, New York City Research and Improvement Networking Group (NYC RING).

The ICTR, which Dr. Marantz co-directs, houses research cores that will provide key support. The Informatics Core, directed by Parsa Mirhaji, MD, PhD, will manage the data for PRIMIER and other BraveNet studies. The Biostatistics and Research Design Core, directed by Mimi Kim, ScD, will provide expert support for the statistics group in the department of family and social medicine. The biostatistics group will also play an important role in the development of new grant proposals for BraveNet. (The ICTR is a member of the nationwide Clinical and Translational Science Awards [CTSA] consortium, funded by the National Institutes of Health.)

Department of family and social medicine’s (DFSM) division of research, which is co-led by Dr. McKee, will supply critical staffing and programmatic and administrative infrastructure for the BraveNet Coordinating Center. DFSM also sponsors NYC RING, for which Dr. McKee is director. The network consists of community-based primary care practices affiliates with Einstein and is one of only a few patient-based research networks in the United States focused exclusively on the urban underserved.

Einstein’s Commitment to Integrative Medicine
In 2000, Einstein became one of the first 13 schools to join the Consortium of Academic Health Centers for Integrative Medicine. Einstein is home to numerous faculty research projects in the field, including investigating the impact of acupuncture on chronic pain-and developing new, rigorous qualitative research methods to evaluate patient responses to integrative approaches.  Many of these projects are based in NYC RING.

Since 2005, Einstein has offered an integrative medicine curriculum to its medical students and recently launched WellMed, the Einstein Student Wellness Program, both of which are co-directed by Dr. Kligler. In addition, integrative medicine is one of eight research tracks offered in Einstein’s Student Opportunities for Academic Research (SOAR) program, which matches medical students interested in conducting research with a mentor.


Source: Albert Einstein College of Medicine of Yeshiva University


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