In the News
New Data Published In European Heart Journal Found HDL3 Cholesterol Subclass To Be Superior In Predicting Cardiovascular Disease Death
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
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
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.
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.
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
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.
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
Botanical Adulterants Program Introduces "Laboratory Guidance Documents" Series to Help Industry Detect Potential Herb Adulteration
The ABC-AHP-NCNPR Botanical Adulterants Program announces the inaugural publication of its Laboratory Guidance Document (LGD) series for botanical ingredients. The LGD on skullcap (Scutellaria lateriflora) is the first in the Program's new series of comprehensive, extensively peer-reviewed, and up-to-date analytical assessments of methods for authentication of the identity of ingredients and detection of adulterants. These free documents – available at no cost thanks to the Program's underwriters and supporters – are intended for use by quality control personnel and lab technicians in the herbal medicine, botanical ingredient, and dietary supplement sectors to help them choose the most appropriate techniques and methods for their specific analytical needs.
The American Botanical Council (ABC)-American Herbal Pharmacopoeia (AHP)-National Center for Natural Products Research (NCNPR) Botanical Adulterants Program (BAP) is an international consortium of nonprofit organizations, analytical laboratories, industry members, professional scientists, and others that advises industry, researchers, health professionals, and the public about the various challenges related to adulterated herb and botanical ingredients sold in commerce. To date, more than 130 American and international parties financially support or otherwise endorse the Program.
"For the first several years of our Program we published articles alerting members of the herb industry about adulteration of specific herbs," said Mark Blumenthal, founder and executive director of the American Botanical Council and director of the BAP. "Now, in addition to our continuing series of publications on adulterated herbs, we are offering technical resources to assist industry and third-party laboratories to detect adulteration and help prevent adulterated botanical ingredients and extracts from being processed into finished consumer products."
Official compendial methods (e.g., those published in the United States Pharmacopeia or the European Pharmacopoeia) exist for the authentication of many botanical materials, but such methods can be outdated for materials that may be adulterated in ways not conceived at the time of the development of officially recognized analytical methods, or may not be applicable to ingredients made using a specific manufacturing process. Additionally, unscrupulous ingredient suppliers driven by short-term financial gains have become more creative in finding ways to deceive a potential buyer's analysts, making the proper detection of adulterants a potentially daunting, time-consuming, and increasingly challenging task.
The ABC-AHP-NCNPR Laboratory Guidance Documents are intended to provide reliable expert guidance on suitable methods to comply with the mandated requirements of testing for identity, purity, strength, and composition outlined in the United States Food and Drug Administration's current Good Manufacturing Practices (cGMPs) for dietary supplements. Per the cGMPs, it is the responsibility of the dietary supplement manufacturers to "conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient."1
The Program's LGDs provide information about the most suitable analytical methods for detection of certain adulterants and authentication of specific botanical materials in the form of whole, cut, or powdered raw materials, extracts, and essential oils. Recommendations are based on a thorough review of available analytical methods (e.g., from official and unofficial compendia as well as the peer-reviewed literature) and input from up to 20 peer reviewers from academia, government, and industry in multiple countries. The primary assessment of each method is based on its performance characteristics (i.e., suitability in detecting known adulterants); labor and analysis time comprise the secondary evaluation criteria.
Stefan Gafner, PhD, ABC chief science officer and BAP technical director, shared his appreciation for everyone who participated in the extensive peer-review process: "I am grateful for the many analytical experts who spent the time to peer-review the Skullcap Laboratory Guidance Document. This process has led to numerous improvements in the paper and has ultimately resulted in a document that is helpful for those whose job it is to determine the authenticity of skullcap and the absence of adulterants."
The BAP's LGDs begin with a statement of purpose and scope in regard to the particular species covered, followed by a short overview of the botanical nomenclature of the species and its known adulterants. Also included are sections on analytical techniques (generally including macroscopic, microscopic, chemical, and genetic assays) and a phytochemical composition overview of the species and known adulterants. The LGDs conclude with a concise table of strengths and limitations of the various assays. Complete references are provided with links to original source documents.
The ABC-AHP-NCNPR Botanical Adulterants Program plans to release additional LGDs in 2015.
For the skullcap and forthcoming bilberry (Vaccinium myrtillus) extract and black cohosh (Actaea racemosa)LGDs, 23, 38, and 31 analyticalmethods were evaluated, respectively, including the following methods: macroscopic analysis, botanical microscopy, genetic analysis, HPTLC, HPLC/UHPLC, flow-injection MS, NMR, and NIR hyperspectral imaging.
"We recently added a skullcap-based product to our line and the conclusions of the [Skullcap LGD] mirror our own," commented Katie Huggins, vice president of Technical Services at Traditional Medicinals, Inc., after reviewing the skullcap LGD. "I can say from experience that having such a document when evaluating a new ingredient for inclusion in a product and when writing specifications would be invaluable."
To date, the ABC-AHP-NCNPR Botanical Adulterants Program has published five extensively peer-reviewed and referenced articles on the history of adulteration, the adulteration of the herbs black cohosh and skullcap, adulteration of bilberry fruit extract, and so-called "grapefruit seed extract." These open-access articles are available on the Program's webpage here. The Program also publishes a quarterly e-newsletter, the "Botanical Adulterants Monitor," that highlights new scientific publications related to botanical authenticity and analysis to detect possible adulteration, recent regulatory actions, and Program news.
GliaCure Completes Phase 1a Clinical Trial in Alzheimer's Disease
GliaCure, a privately-held biotechnology company focused on the development of novel therapies for neurological and neuropsychiatric disorders based on glial targets, announced today that it has successfully completed its Phase 1a clinical trial of its lead product candidate, GC021109, a compound developed as a disease-modifying treatment for Alzheimer's disease. The trial, which began on September 22, 2014, included single dosing of 44 healthy volunteers and demonstrated the safety, tolerability, and excellent pharmacokinetic properties of GC021109.
"We are very excited to have reached yet another milestone in the development of GC021109," said GliaCure director and co-founder Mike Szulczewski. "We look forward to testing the safety and tolerability of the drug in mild to moderate Alzheimer's patients, and of course to ultimately producing a therapy that can modify the disease, at least in its early stages, rather than just treat symptoms." GliaCure's approach to treating Alzheimer's disease is novel in that it promotes both the clearance of amyloid and stimulates anti-inflammatory actions through a single target.
Data from GliaCure's Phase 1a study is being used to determine dosing in the company's upcoming Phase 1b trial, a multiple ascending dose study in mild-to-moderate Alzheimer's patients. Site selection for this Phase 1b trial is currently underway and first dosing is planned for Q1 2015.
Study of Castle Biosciences’ Skin Melanoma Gene Test Published in Clinical Cancer Research
Castle Biosciences Inc. today announced the publication of a clinical validation study of its gene expression profile (GEP) test for cutaneous melanoma. DecisionDx-Melanoma accurately predicts metastatic risk independent of current diagnostic modalities including AJCC staging. The paper, “Development of a Prognostic Genetic Signature to Predict the Metastatic Risk Associated with Cutaneous Melanoma,” was published today in Clinical Cancer Research, a publication of the American Association for Cancer Research (AACR).
“Development of a Prognostic Genetic Signature to Predict the Metastatic Risk Associated with Cutaneous Melanoma”
The results show that DecisionDx-Melanoma accurately predicts metastatic risk in Stage I or Stage II melanoma patients who have no sign of disease beyond the original tumor.
“The behavior of melanoma tumors is highly variable, and often cannot be accurately predicted using traditional staging methods,” commented Pedram Gerami, MD, a study author and Associate Professor of Dermatology, Director of Melanoma Research at the Northwestern Skin Cancer Institute, Northwestern University. “These results demonstrate that a gene signature can accurately predict metastasis, particularly in tumors that were assumed to be lower risk due to stage, size and other characteristics. This test can have a significant impact on the management and potentially long term outcomes of these melanoma patients.”
In the multicenter development and clinical validation studies published today, formalin-fixed, paraffin-embedded specimens from biopsy or wide excision procedures of primary cutaneous melanoma tumors were analyzed to observe changes in the expression of 28 discriminating genes. There are 3 control genes, resulting in a 31 gene panel. Based on the GEP test results, melanoma tumors were classified as either Class 1 (low risk of metastasis) or Class 2 (high risk). Patients’ clinical outcomes at 5 years after diagnosis were compared with the GEP test prediction.
Overall, Kaplan-Meier analysis indicated that the 5-year disease free survival (DFS) rates in the independent validation study (n=104) were 97 percent and 31 percent for predicted Class 1 and 2, respectively (p<0.0001). These results are comparable to results from a separate analysis of the development cohort (n=100), which found DFS rates of 100 percent and 38 percent for predicted Class 1 and Class 2 cases, respectively (p<0.0001).
The DecisionDx-Melanoma test demonstrated an ability to identify high and low risk tumors in Stage I and Stage II melanoma subgroups across the development and validation study cohorts (n=220):
-The GEP test accurately identified as Class 1 (low risk) 120 of 134 (90 percent) Stage I and IIA patient cases without documented evidence of metastasis.
-It correctly identified 24 of 30 (80 percent) Stage I and IIA cases with documented metastasis as Class 2 (high risk).
-Importantly, of 9 Stage I patient cases with documented metastasis, 5 (56 percent) were accurately classified as Class 2 (high risk) by the GEP test.
-Conversely, 104 of 110 (95 percent) Stage I cases without documented metastasis were accurately classified as low risk (Class I) by the GEP test.
“The ability to more accurately stratify patients based on actual risk can have a significant impact on patients diagnosed with Stage I or II cutaneous melanoma,” commented David H. Lawson, MD, Professor of Hematology & Medical Oncology, Winship Cancer Institute, Emory University and study author. “Patients identified as high risk may choose to be monitored as if they were Stage III. Additionally, the psychological and emotional burden of a melanoma diagnosis may be lessened for patients receiving a Class 1, low risk diagnosis. This test, in combination with AJCC staging, provides caregivers with the most accurate prognostic tools currently available for managing patients diagnosed with melanoma. Ongoing studies will further define how this test can best be used in conjunction with the current AJCC staging system and to determine whether adjuvant therapy for the higher risk patients can alter the natural history of this disease.”
The paper can be accessed at http://clincancerres.aacrjournals.org/content/21/1/175.full.