Past News Items - Dec 2014

GenomeDx Biosciences announced yesterday that a new study showed that the Decipher Prostate Cancer Classifier, a genomic test for prostate cancer, was able to predict rapid metastatic disease in node-negative, high-risk men managed by radical prostatectomy without adjuvant therapy. Although rapid metastasis in men treated with radical prostatectomy is relatively uncommon, using tumor genomics to identify these men who have a highly lethal form of metastatic disease is an important advance. The study has been published online by the journal European Urology.

The findings highlight the significance of identifying the patients at highest risk of rapid metastasis for timely treatment after surgery:

>>Of men who had rapid metastasis within five years, while all initially had undetectable PSA after surgery and were indistinguishable by standard clinical and pathologic features, 50 percent developed bone metastasis by two years and 50 percent died of their disease within seven years after surgery.

>>Of men experiencing late metastasis, none died of their prostate cancer at seven years after surgery and the median time to metastasis was more than nine years.

"Clinical and pathological risk factors were not able to distinguish which among the patients at risk of recurrence in our cohort might develop rapid metastatic disease," said Eric Klein, MD, chairman of the Glickman Urological and Kidney Institute at Cleveland Clinic. "Identification of such patients is clinically relevant, as those at highest risk for rapid metastasis and death are mostly likely to benefit from earlier, more intensive therapy and inclusion in clinical trials of novel agents. Perhaps what is more important for the average patient treated with radical prostatectomy at our institution is the high negative predictive value of this genomic test. Our study suggests that a patient with genomic low risk, despite having adverse pathology findings, is likely best managed conservatively after surgery and may safely avoid radiation therapy and the associated adverse side effects." Dr. Klein is a paid consultant for GenomeDx Biosciences.

The study, titled "A Genomic Classifier Improves Prediction of Metastatic Disease Within Five Years After Surgery in Node-negative High-risk Prostate Cancer Patients Managed by Radical Prostatectomy Without Adjuvant Therapy," evaluated 169 patients who had a preoperative PSA of greater than 20 ng/mL, a negative pathologic node, undetectable PSA following prostate surgery, and did not have neoadjuvant or adjuvant therapy. Fifteen patients experienced rapid metastasis, defined as occurring within five years of surgery, and 34 had late metastasis, defined as occurring more than five years after surgery. When the Decipher results were applied, Decipher demonstrated the highest prediction of metastatic disease compared to the Stephenson and CAPRA-S nomograms, with an AUC of 0.77 compared with 0.75 and 0.72 respectively. In addition, integration of Decipher into the Stephenson nomogram resulted in an increased performance as measured by AUC of 0.79.

"The clinical utility of Decipher in this patient population may have the most impact, beyond nomograms, on identifying more patients who, despite having multiple adverse pathology findings after surgery, have a high probability of metastasis-free survival even when managed conservatively without adjuvant therapy," said Elai Davicioni, PhD, founder and CSO of GenomeDx. "Further, this study showed that Decipher was able to better identify the few patients with a highly lethal form of metastatic disease who have the most to benefit from earlier, more intensive adjuvant therapy."

Source: GenomeDx Biosciences, genomedx.com

Released: 12/19/14

Report: Five Fastest-Growing Tests in Physician Office Labs

Although the market for IVD products sold in physician office labs (POLs) is expected to show minimal growth, certain test categories will perform above average in terms of revenues, according to Kalorama Information. Kalorama found that the market grows a little more than 3 percent per year, but that certain tests will see faster revenue growth. The finding was made in Kalorama Information's recent report, “Physician Office Laboratory Markets.”

Kalorama last conducted a survey of physician office labs in 2010. Its updated physician office report is available at kaloramainformation.com/Physician-Office-Laboratory-8339073/.

The POL market encompasses a variety of institutions beyond physician practices, including specialty and multispecialty clinics, other primary care and urgent care clinics, and outpatient clinics not located or associated with a hospital (or hospital lab) or outpatient surgical services. Physician office laboratories are diverse in their capabilities and setting. Individual practitioners may simply perform reimbursable, in-office pregnancy and glucose tests. Some specialty practices and clinics run CBCs and chemistry panels using small lab and benchtop automated analyzers requiring moderate complexity CLIA compliance. Medicare physician filings also indicate POLs perform moderate complexity infectious disease tests using plate immunoassays and molecular assays, as well as in-situ hybridization tests using tissue samples.

According to the report, the following tests will demonstrate faster-than-average revenue growth in the global POL market.

>>Anemia tests and markers, including B₁₂/folate, serum iron, total iron binding capacity (TIBC), and ferritin, largely round out the POL market for anemia tests. Test demand remains high due to demographic aging as well as the clinical prevalence of anemia and available remedial treatments able to be initiated by primary care practitioners.

>>Microalbumin is an important marker of kidney function in diabetics that has seen increased usage by physicians worldwide. With increasing standards of diabetic care and intervention in the developing world, and still-rising usage of the test in North America and Europe, the POL microalbumin test market is expected to demonstrate revenue growth of 10 percent per year.

>>Cardiac Markers (CK-MB, other assays of creatine kinase [CK], troponins, myoglobin, and BNPs) on laboratory medicine and rapid tests are used for the early detection of CVD risk in at risk individuals.

>>CRP is a known marker of chronic inflammation and can be used to detect infections and differentiate between bacterial (significantly elevated CRP) and viral infections. High-sensitivity CRP (hsCRP) is an assay form increasingly present on POC analyzers and is used to determine if slightly elevated CRP levels are present, an indicator of CVD risk. CRP tests are much more widely used in European POLs, especially German and Swiss markets, than in US POLs.

>>HbA1c, or glycated hemoglobin, is usually checked on diabetics during their routine visits. HbA1c is a hemoglobin variant with attached glucose that is clinically significant as a measure of long-term blood sugar levels (or hemoglobin's exposure to glucose) and as an evaluation tool for patient glucose control. Ideally, insulin-dependent diabetics should have their HbA1c fraction tested every 3 months. The HbA1c test market does not depend upon frequent consumer testing to generate volume, but rather has delivered growth through more regular patient screening, the limited introduction of self-testing, and rising application in healthcare systems worldwide.

In addition to these areas, Kalorama sees the possibility that molecular tests will reach the POL. Routine infectious disease testing has invited the first forays of molecular diagnostics into the space. Several molecular platforms already support ease-of-use, moderately complex flu assays that can be performed outside of central labs. While CLIA waivers for such molecular assays would assuredly boost their market potential, regulators' concerns over CLIA-waived test QA/QC measures among POC users will likely delay the first such milestone waiver for molecular POC. Moderate-complexity molecular systems' penetration among CLIA-certified POLs is expected to represent only a minor paradigm of growth for the overall POL market.

Source: Kalorama Information, KaloramaInformation.com

Released: 12/17/14

Research Finds Nerve Damage in Patients With Fibromyalgia

Therapath, LLC a leader in neuropathology laboratory services, reports that new findings have revealed that patients diagnosed with fibromyalgia may also have a diagnosable small fiber neuropathy.

Recently, several studies have examined fibromyalgia patients for small fiber neuropathy using a skin biopsy test to determine Epidermal Nerve Fiber Density (ENFD). The studies reported a decrease in ENFD in a subset of patients with fibromyalgia (Oaklander et al., Pain 2013; Caro & Winter, Arthritis Rheumatology 2014; Giannoccaro et al., Muscle Nerve 2014). These studies conclude that ENFD testing should be considered in the diagnostic work-up of fibromyalgia to search for small fiber neuropathy.

therapath.com/rheumatology

Patients diagnosed with small fiber neuropathy exhibit similar symptoms to those with fibromyalgia, including:

· Chronic pain

· Increased sensitivity to pressure and touch

· Numbness and tingling

Epidermal Nerve Fiber Density (ENFD) is an objective measure of the small nerve fibers. To perform the test, a doctor performs a biopsy in the office to obtain a small piece of skin. That skin sample is then sent to a neuropathology laboratory for analysis. Patients with small fiber neuropathy exhibit a significant reduction in the ENFD

therapath.com/enfd

SOURCE Therapath, LLC

Released: 12/17/14

From Fish Food to Superfood: Marine Phytoplankton 5000 Gives Consumers Powerful Defense Against Ravages of Oxidative Stress

A patent-pending technology has made it possible to pack more age-defying Superoxide Dismutase – otherwise known as SOD – into a capsule than ever before. Sold in the US as Marine Phytoplankton 5000, this new product has been sourced from a state-of-the-art facility on the Atlantic coast of Spain. Health-conscious consumers interested in trying this new superfood plankton can buy it online at Plankton5000.com.

Marine phytoplankton are small – smaller than a red blood cell, in fact – but the impact they have on Earth's ecosystems is too large to calculate. As the foundation of the food chain, these tiny plants literally make life possible for everything else in the ocean. Not only that, marine phytoplankton produce most of the oxygen on the planet, which means their influence extends to all major landmasses as well.

For the purposes of health food makers and consumers, marine phytoplankton are an incredible source of SOD. Researchers have identified SOD as far and away the most important nutrient in combating oxidative stress. Oxidation, a natural and continuous process of energy creation within the body, produces harmful "free radicals" as byproducts. Chemical pollutants, stress, alcohol and smoking, among other factors, can ramp up the number of free radical molecules even further. These unstable molecules cause significant damage to healthy molecules. The aging process itself is largely a result of free radicals acting on organs and tissues, and oxidative stress is correlated with almost every known disease. Simply put, more SOD in a person's diet means less oxidative stress in his or her body.

Marine Phytoplankton 5000 contains TetraSOD, a strain of phytoplankton grown with the help of technology that dramatically increases the yield of SOD. Non-GMO TetraSOD contains 10 to 15 times as much SOD as typical strains of phytoplankton. The plants are grown in an enclosed and carefully maintained facility that uses real ocean water, which is routinely tested for impurities and pollutants.

Vegetarian-friendly Marine Phytoplankton 5000 is available in 5,000 units to over 30,000 units of SOD per serving. Plankton qualifies as a whole food, and the SOD in Marine Phytoplankton 5000 is entirely natural and unprocessed. In contrast, many food and dietary supplements are chemically altered or contain fillers that are detrimental to the efficiency of the active ingredients.

The makers of Marine Phytoplankton 5000 are confident that their products are both safe and effective and have extended a 90-day, money-back guarantee on every bottle sold. Learn more about this remarkable superfood supplement at marinephytoplankton5000.com/.

SOURCE Marine Phytoplankton 5000

Released: 12/17/14

Thorne Research Announces Clinical Study Agreement with Mayo Clinic for Dietary Supplements

Thorne Research Inc., a leader in developing and manufacturing pure, high-quality nutritional supplements, announced yesterday a new dietary supplement clinical study agreement with Mayo Clinic. Starting in January 2015, Thorne Research and Mayo Clinic will begin conducting a series of randomized double-blind placebo-controlled clinical trials on a number of dietary supplements, under a master clinical study agreement. Working with physicians and PhD scientists, trials will be conducted at Mayo Clinic, with the intent of raising the bar on dietary supplement research, leading to improved patient outcomes.

“The studies are designed to test the safety and efficacy of a range of single compounds from natural sources, plant extracts with complex molecular attributes, and complex nutritional products formulated to address specific nutritional needs,” said Robert Rountree, MD, chief medical officer for Thorne Research. The primary focus will be to test materials that are considered GRAS (Generally Recognized as Safe) within the FDA designation, and to emphasize the understanding of mechanism of action, safety, pharmacokinetics, and optimal dosage for these products.

Trials will involve conditions with significant human need, sports related performance, recovery and injury, and nutritional support for pre- and post- surgical care. The results will be used to develop supplements, medical foods, functional foods, and botanical drugs.

Thorne also intends to refine and test leading formulations from Traditional Chinese Medicine (TCM). There is a need to standardize Chinese botanical mixtures for their multiple molecular active components, both to assure the biological activity of the finished products and to assure that the finished TCM products are free of pesticides, herbicides, and adulterants. Thorne plans to run clinical trials and potentially work with partners from China to take advantage of centuries of knowledge in this field.

In December of 2013, Thorne Research acquired a minority interest in the web- and mobile-based platform WellnessFX, which facilitates blood analysis and data display for use in individual, corporate, clinical, and other settings. This platform is available for use in research studies conducted through the clinical study agreement with Mayo Clinic. Thorne is particularly interested in the use of the WellnessFX platform in telemedicine and personalized care to take advantage of the potential to enhance the doctor-patient experience, with further applications in corporate and individual wellness, disease management, and athletic training.

According to Paul Jacobson, CEO of Thorne Research, “The natural product sector is poised for a dramatic transition in public acceptance and public scrutiny. This is driven, in part, by a phenomenon influenced by corporate decision makers. In surveys of consumers, 60 to 80 percent of people state that they use nutritional supplements. This situation presents a dilemma for corporate entities, such as athletic organizations, corporate wellness programs, medical practices, healthcare providers, consumer membership organizations, and many others. On the one hand, these groups know their people use supplements, but they worry there is wide range of quality, safety, and efficacy. Recommending specific supplement lines is a risk they’ve traditionally avoided. However, they are also aware that failure to make recommendations leaves their people subject to the wide variability in product quality. Organizations are now looking to make more deliberate moves toward recommendation. It is our view that only those companies who raise the bar in quality, safety, and efficacy with sound, transparent practices will be up to the standards required for such opportunities. Our research with Mayo Clinic addresses the rigors commensurate with this growing scale of opportunity and responsibility.”

Source: Thorne Research, thorne.com.

Released: 12/16/14

Cancer Treatment Centers of America Selects WCG to Facilitate the Expansion of its Clinical Research Program

WIRB-Copernicus Group (WCG), the world's largest provider of regulatory and ethical review services and software to support clinical research, announced yesterday that it has been chosen by Cancer Treatment Centers of America(CTCA) to help expand its clinical research program. WCG will assist CTCA in the centralization and optimization of its regulatory and ethical review process, allowing CTCA to manage a higher volume of cutting-edge research while maintaining the highest degree of participant protection. CTCA is a leader in integrative cancer care with a national network of five state-of-the-art hospitals in Atlanta, Chicago, Philadelphia, Phoenix, and Tulsa.

WCG chairman and CEO Donald A. Deieso, PhD, commented, "CTCA is recognized as a leader in the field of oncology, offering comprehensive and innovative therapies to treat cancer patients. It is therefore no surprise that CTCA is assuming a more prominent role in the conduct of oncological research and follows the most rigorous, industry-leading practices to assure participant safety and regulatory compliance. We are proud to partner with CTCA and help grow its clinical research program."

"At CTCA, we are committed to offering our patients leading-edge cancer treatments through the continued expansion of our portfolio of evidence-based treatment options. To support our growth, we are adopting new practices to make the ethical and regulatory oversight of our clinical trials more efficient," said president of CTCA medicine and science Maurie Markman, MD. "WCG, with its significant experience in reviewing oncology research, is an ideal partner to help us expand our research program while maintaining the highest standard of human subject protection."

WCG Oncology, WCG's oncology-focused oversight division, will partner with CTCA in this process. Composed of industry luminaries, expert consultants, and three dedicated institutional review boards (IRBs), WCG Oncology provides a thorough review of oncology research, and brings a deep understanding of the changing oncology research landscape, cutting-edge theory, scientific methods, technologies, and study designs to the process.

CTCA will also benefit from WCG's guidance in the centralization and optimization of its internal IRB. Composed of CTCA experts, and administered according to WCG's standard operating procedures, this CTCA panel is fully accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP) through Western IRB (WIRB). Achieved by only 200 of approximately 3,000 IRBs in the United States, AAHRPP-accreditation confirms CTCA's adherence to the highest standards of ethical review and human subject protection.

Source: WIRB-Copernicus Group
Related links: wcgclinical.com, cancercenter.com

Released: 12/12/14

Australian Study Puts Victoria Center Stage of the Smart Meter Controversy

A 92-case series report by Melbourne medical practitioner Dr. Federica Lamech, titled “Self-Reporting of Symptom Development From Exposure to Radiofrequency Fields of Wireless Smart Meters in Victoria, Australia: A Case Series.” has just been published in the Nov/Dec 2014 issue of the US clinical journal Alternative Therapies in Health and Medicine. The journal is a PubMed-listed, peer-reviewed publication.

The case series was compiled using de-identified data collected by Steve Weller, BSc, vice-president of SSMA Inc., through the Health Register and Legal Register he had set up on this website.

It reveals that the most commonly reported symptoms from exposure to wireless smart meters were, in this order: insomnia, headaches, tinnitus, fatigue, cognitive disturbances, dysesthesias (abnormal sensation), and dizziness.

The case series also revealed that the effects of these symptoms on people’s lives were significant, and included:

>>Having to go on a disability pension

>>Not being able to use part of one’s house

>>Restricting freedom of movement

>>Spending a lot of money on shielding products

>>Causing financial problems

>>Causing relationship problems

>>Having to undergo otherwise unnecessary medical investigations

>>Needing to see a psychologist and doctors

>>Producing general deterioration in quality of life

>>Needing to restrict time spent using a computer

>>Needing to avoid all EMR (electromagnetic radiation)-emitting devices

>>Being unable to drive

>>Causing secondary stress

>>Having to temporarily move out of one’s home while it was being shielded

>>Developing concerns about long-term effects of exposure

>>Relocating bedroom

>>Decreased performance at work

>>Being unable to work

>>Being able to feel normal only when away from home

>>Causing several issues, such as lethargy or cognitive impairment, secondary to sleep disturbances

>>Needing to move into a caravan 25 km out of town

>>Sleeping in a van for 6 months

>>Relocating to another state

A draft of the report had already gained support from the American Academy of Environmental Medicine (AAEM) last year with a public statement by them that, “It is a well-documented 92-case series that is scientifically valid. It clearly demonstrates adverse health effects in the human population from smart meter emissions.”

Stop Smart Meters Australia is of the opinion that this report will help the global, international effort to better understand the effects of nonionizing radiation, and of wireless smart meters in particular, on human health.

Dr. Lamech “offers the hypothesis that some people can develop symptoms from exposure to radiofrequency fields of wireless smart meters.” She concludes that, “This hypothesis cannot be disproven without further assessment of the affected individuals and the electromagnetic fields in which they live.” Dr. Lamech calls for “the establishment of a post-rollout surveillance study and funding for further research into the particular effects of wireless smart meters, in conjunction with research into the short-term and long-term consequences of EMR exposure.”

The PubMed listed abstract can be found here: ncbi.nlm.nih.gov/pubmed/25478801

For a comprehensive commentary on the report by SkyVision Solutions, visit: smartgridawareness.org/2014/12/07/symptom-development-from-smart-meter-rf-exposure/#more-9615

The full article (which is copyrighted) can be obtained by purchasing an individual copy for $15 here: scribd.com/doc/249193352/Self-Reporting-of-Symptom-Development-From-Exposure-to-Radiofrequency-Fields-of-Wireless-Smart-Meters-in-Victoria-Australia-A-Case-Series

Source: Alternative Therapies, alternative-therapies.com

Released: 12/11/14

Emerson Ecologics Launches Practitioner Resource Center for Integrative Healthcare Providers

Emerson Ecologics recently unveiled its newly designed Practitioner Resource Center, a full suite of clinical and business tools, resources and education designed to help integrative healthcare providers find success as healers and business owners.

The Practitioner Resource Center includes a rich variety of materials that can help healthcare providers stay up to date on clinical knowledge and treatment plans, improve patient compliance, learn new strategies for growing their practice and more.

“We’ve always been committed to helping our customers succeed as integrative healthcare practitioners, and our newly designed Practitioner Resource Center is an extension of that commitment,” said Dr. Jaclyn Chasse, Medical Director for Emerson Ecologics. “We recognize how busy our customers are, so our educational resources and materials are available in many different formats. And the majority of what we offer is available free of charge.”

The Practitioner Resource Center offers clinical references, FAQs, peer-to-peer support via email or phone, educational webinars, detailed product literature, the IGNITE series of business-oriented workshops and more. Sample resources include:

>>Dietary and lifestyle recommendations for specific health conditions

>>Online databases listing drug depletions and interactions

>>Personalized answers to questions about integrative health treatments from Emerson’s Medical Education team

>>Summaries of selected clinical research on select dietary supplement ingredients

>>Educational materials and webinars designed to help practitioners grow their business and attract new patients

>>Active compounds, suggested dosage and potential interactions for botanical herbs

>>Calendar, links and resources designed to help practitioners stay on top of industry research and/or maintain professional credentials

>>Suggested dosage and potential interactions for vitamins and supplements

To learn more about Emerson Ecologics, visit emersonecologics.com.

Released: 12/09/14

New Study: Art Therapy May Build Self-Esteem in People Living with Epilepsy

People living with epilepsy report increased self-esteem after participating in Studio E: The Epilepsy Art Therapy Program, according to a new study presented today at the annual meeting of the American Epilepsy Society (AES), in Seattle, Wash. Studio E is a multi-week program made possible nationwide through a partnership between the Epilepsy Foundation and the pharmaceutical company Lundbeck.

“The Impact of an Art Therapy Program on Self-Esteem and Quality of Life in People with Epilepsy.”

“We consistently witness the therapeutic power of art therapy among Studio E participants across the country, whether it be increased confidence or a release from stigma among people previously hesitant to share their epilepsy story with others,” said Lacy Vitko, lead art therapy coordinator at the Epilepsy Foundation’s national office in Washington D.C., and co-author of the study. “This study brings further validity to the inspirational transformations we’ve seen among participants in Studio E sessions.”

The Epilepsy Foundation and Lundbeck partnered in 2011 to pilot Studio E in four U.S. cities. Given the program’s success, it was gradually expanded in 2012 and 2013, and is now available in nearly 50 U.S. cities, making it the first national program of its kind. It is offered free of charge through the Epilepsy Foundation’s network of affiliates and Lundbeck’s financial and volunteer support.

“My involvement in this program dates back five years when we first started doing epilepsy art therapy in Chicago, and it was a dream of mine to make this possible throughout the country,” said Jill Gattone, manager of epilepsy advocacy and patient support at Lundbeck, and co-author of the study. “The transformation in terms of increased self-expression, confidence and friendships at every Studio E program compel us to keep improving and expanding.

Released: 12/08/14

New Strategies Boost Healthy Red Blood Cell Production to Target Anemia Across A Range Of Blood Disorders

Emerging treatment approaches may reduce the burden of anemia associated with blood disorders by enhancing production of healthy red blood cells, according to data presented today at the 56th American Society of Hematology (ASH) Annual Meeting and Exposition.

Many blood diseases are linked to anemia caused by a deficiency of healthy red blood cells (RBCs). These deficiencies occur either when the body cannot maintain adequate RBC production or, instead of healthy adult RBCs, it produces immature cells that cannot transport oxygen throughout the body. Myelodysplastic syndromes (MDS), beta thalassemia, and sickle cell disease (SCD) are examples of these types of disorders and are associated with moderate to severe anemia.

Many people suffering from anemia are treated with erythropoiesis-stimulating agents (ESAs, which help the bone marrow produce RBCs), or hydroxyurea, a chemotherapy agent that reduces the number of unhealthy cells in the blood. However, patients who do not respond to these agents must rely on regular blood transfusions to maintain proper RBC levels. While effective, transfusions are expensive, time-consuming, and associated with unique complications such as iron overload.

New research being presented today suggests that a new class of agents, known as activin receptor fusion proteins, may reduce the burden of anemia by encouraging healthy RBCs to mature and proliferate, providing a much-needed alternative to current options. Two treatments in this class offer similar mechanisms and are under investigation for use in patients with low-risk MDS and beta-thalassemia. A separate study suggests that a complementary approach using the amino acid L-glutamine may support healthy RBC growth and diminish the complications of anemia with minimal side effects. Finally, a long-term observational analysis characterizes the natural history of SCD, better illustrating the early mortality associated with the disease and identifying opportunities for intervention during the transition from pediatric to adult care.

"Anemia is a persistent burden for many patients with blood disorders, particularly because many of these patients cannot tolerate current treatments or must rely on regular blood transfusions," said Julie Panepinto, MD, MSPH, moderator of the press conference and professor at the Medical College of Wisconsin and Children's Hospital of Wisconsin in Milwaukee. "We are optimistic about new strategies being presented today to support healthy red blood cell production without causing additional complications for these chronically ill patients."

This press briefing will take place on Sunday, December 7, at 8 a.m. PST in rooms 236-238 of Moscone South, East Mezzanine.

Drug Increases Red Blood Cell Production, Reduces Transfusion Burden in Patients with Myelodysplastic Syndromes
An Open-Label, Phase 2, Dose-Finding Study of Sotatercept (ACE-011) in Patients with Low or Intermediate-1 (Int-1)-Risk Myelodysplastic Syndromes (MDS) or Non-Proliferative Chronic Myelomonocytic Leukemia (CMML) and Anemia Requiring Transfusion [3251]

Anemia is the most challenging complication of myelodysplastic syndromes (MDS), one of the most common blood cancers, and determining optimal treatment remains an unmet need. Among several investigational treatments that aim to promote red blood cell (RBC) growth is sotatercept (ACE-011), a drug that has shown efficacy in early studies with healthy volunteers. This drug, an injectable activin type IIa receptor fusion protein, is designed to attach to a molecule that inhibits erythrocyte (immature RBC) production.

In this Phase II clinical trial, the first study to evaluate sotatercept in MDS patients and seeking to determine the optimal dose of the drug, researchers enrolled 54 largely transfusion-dependent patients who had not responded to treatment with erythrocyte-stimulating agents (ESAs) and other available MDS treatments. The treatment was administered once every three weeks for four doses, and was continued among responders. After treatment with the experimental drug, 45 percent of all evaluable patients experienced either a reduced need for transfusions or an increase in hemoglobin levels. In addition, 19 of the 45 patients who were in the highly transfusion-dependent group prior to receiving sotatercept therapy demonstrated a reduced need for transfusions, including five who became transfusion-independent. The majority of patients (5 of 8) in the less-transfusion-dependent group prior to sotatercept therapy achieved both transfusion independence and increased hemoglobin levels. The treatment was generally well tolerated; 37 percent of patients reported one or more treatment-related adverse events.

"This drug shows promise as an agent that may reduce the burden of regular blood transfusions or eliminate this need among anemic, lower-risk MDS patients," said lead study author Rami S. Komrokji, MD, of Moffitt Cancer Center in Tampa, FL. "Importantly, the response rates are more encouraging in our study than most rates reported with other investigational agents. Larger, randomized studies are necessary to confirm these promising results and evaluate whether a higher dose may provide greater benefit without additional toxicity."

Dr. Komrokji will present this study at 6:00 p.m. PST on Sunday, December 7, in the Poster Hall on Level 1 of Moscone West.

Drug Boosts Hemoglobin Levels, Decreasing Transfusion Burden in Beta-Thalassemia Patients
ACE-536 Increases Hemoglobin and Decreases Transfusion Burden and Serum Ferritin in Adults with Beta-Thalassemia: Preliminary Results from a Phase 2 Study [53]

A second compound in a new class of activin receptor proteins, ACE-536, is under investigation to treat beta-thalassemia, a blood disorder characterized by reduced hemoglobin production. Patients with this condition often do not respond well to conventional erythropoietin-stimulating agents (ESAs).

This ongoing, Phase II dose-finding trial is studying ACE-536 among adults with transfusion-dependent (TD) and non-transfusion dependent (NTD) beta-thalassemia, evaluating the compound's ability to stimulate more effective erythropoiesis. The treatment is injected once every three weeks for up to five doses at sequentially increasing dose levels with a two-month follow up. As of July 2014, preliminary data for 30 patients (7 TD and 23 NTD patients) receiving several dose levels of ACE-536 demonstrated increased hemoglobin levels among the NTD patients and a significant reduction in transfusion burden (greater than 50%) among the TD patients. No serious adverse events were reported to be related to the treatment, and no notable changes in platelets or white blood cell counts were observed.

"While preliminary, these data indicate that ACE-536 may be effective in increasing hemoglobin levels and decreasing transfusion burden in patients with beta-thalassemia," said lead study author Antonio G. Piga, MD, of University Hospital San Luigi Gonzaga in Torino, Italy. "As no treatments are approved for beta-thalassemia, we are optimistic that ongoing studies will support use of this treatment, with the goal of reducing or even eliminating blood transfusions for these patients."

Dr. Piga will present this study at 12:00 noon PST on Sunday, December 7, in the Golden Gate Hall of the San Francisco Marriott Marquis.

L-Glutamine Reduces Pain Crises, Other Common Events Associated with Sickle Cell Disease
A Phase 3 Study of Oral L-Glutamine Therapy for Sickle Cell Anemia and Sickle Beta Thalassemia [86]

Sickle cell disease (SCD) is a chronic condition with few treatment options available. The most commonly utilized treatment is oral hydroxyurea, but because of its potential severe side effects, it is not appropriate for use among all patients. This study evaluated the use of pharmaceutical-grade
L-glutamine as a new, daily oral treatment option for SCD based upon the theory that it may reduce oxidative stress and therefore decrease the red blood cell (RBC) "sickling" associated with the disease.

To study the efficacy and safety of L-glutamine for SCD, researchers enrolled 230 patients with SCD into a multi-center, Phase III clinical trial. Study participants were randomized to receive daily L-glutamine (152 patients) or placebo (78 patients) for 48 weeks, after which treatment levels were tapered to zero. Researchers observed that patients who received L-glutamine experienced fewer painful crises and a longer time to a pain crisis than patients receiving placebo. Treated patients were also less likely to be hospitalized for their condition (2 vs. 3 events during the study period) and spent less time in the hospital for these events (6.5 vs. 11 days) than those receiving placebo. Importantly, the percentage of patients experiencing acute chest syndrome, a severe complication of SCD, was less than half among the L-glutamine group compared to the placebo group (11.9% vs. 26.9%). The treatment was well tolerated, as safety profiles were similar among the treatment and placebo groups.

"These findings support the use of L-glutamine in SCD patients, as it appears to safely reduce the most common events associated with the disease," said lead study author Yutaka Niihara, MD, of Emmaus Medical, Inc. in Torrance, CA. "Unlike more intense regimens that require infusions and regular monitoring, this approach could offer a very simple oral alternative, making it particularly compelling."

Dr. Niihara will present this study at 4:30 p.m. PST on Sunday, December 7, in the Golden Gate Hall of the San Francisco Marriott Marquis.

Study Provides Accurate, Modern Natural History of Survival in Sickle Cell Disease
Survival into Adulthood in Sickle Cell Disease from the Dallas Newborn Cohort [559]

Despite advancements in treatments for sickle cell disease (SCD) that have improved outcomes, early mortality remains a critical issue, and accurate survival estimates are difficult to determine because of the lack of long-term follow up on this patient population.

To better illustrate the experience of sickle cell patients and identify risk factors for early death, the Dallas Newborn Cohort (DNC) was created to follow every infant born in Texas with SCD and receiving treatment at the University of Texas Southwestern Medical Center and Children's Medical Center Dallas. Since its inception in 1983, the DNC has followed 1,214 patients from birth until their transition to adult care. While previous DNC reports were unable to estimate SCD patient survival into adulthood, in this update the team utilized the National Death Index and medical records from local hospitals to extend survival estimates into adulthood. As of the latest analysis in December 2013, 91 percent of patients in the cohort experienced overall survival to age 25 and four percent of the cohort (53 patients) had died. Predictors for early death included genetic indicators of severe disease, lower baseline hemoglobin, and lower baseline oxygen saturation.

"With real-world data from birth to adulthood in a large group of patients, the DNC provides an accurate, modern picture of the natural history of sickle cell disease," said senior study author Timothy L. McCavit, MD, MS, of UT Southwestern Medical Center in Dallas. "While these patients are living longer with a better prognosis, the acceleration of early mortality in the early 20s illustrates the need to better address patients' transition from pediatric to adult care."

Dr. McCavit will present this study at 4:30 p.m. PST on Monday, December 8, in the Golden Gate Hall of the San Francisco Marriott Marquis.

Editor's Note: Recently, the National Heart, Lung, and Blood Institute (NHLBI) issued an evidence-based expert panel report on the management of sickle cell disease (SCD) aimed at improving the care of SCD patients. The report addresses all aspects of care, including treatment of acute complications, management of chronic complications, and the use of disease-modifying therapies. (Read about ASH's endorsement of the report here.)

SOURCE American Society of Hematology

Released: 12/04/14

Cell Science Systems Launches Telomere Testing: May Reveal Biological Age

Cell Science Systems Corp., one of the very few labs to offer telomere length testing, has launched its new version of this test at an affordable price. Knowing your telomere length is important because it directly relates to health and longevity.

Telomere length testing has recently become of wider interest following a study at Brigham and Women's Hospital, published just this week in the BMJ. In the study, “Mediterranean diet and telomere length in Nurses' Health Study: population based cohort study,” researchers analyzed 4,676 disease-free women who had their telomeres measured and completed biennial food frequency questionnaires.

They found that women who follow the Mediterranean diet rich in vegetables, fruits, nuts, legumes, and unrefined grains had longer telomere length. Longer telomere length is usually associated with greater health and longevity.

Telomeres are repetitive, non-encoding DNA sequences at the ends of chromosomes that get shorter each time a cell divides. They are analogous to the plastic tips on shoe laces and protect the DNA that gets copied. Shorter telomeres are associated with a decreased life expectancy and increased rate of aging-related disease.

What do you do if your telomeres are not as long as you'd like? Cell Science Systems is also well known for its proprietary method of food and chemical sensitivity testing: the Alcat Test. Food and chemical sensitivities have been linked to inflammatory processes—and inflammatory processes shorten telomeres.

David Blyweiss, MD, MPH, chief medical officer for Cell Science Systems, states, "This research supports our view that diet plays a critical role in overall health and aging. Combining the Alcat Food Sensitivity Test with Telomere Length testing is a perfect marriage. The Alcat blood test can help determine which foods and other substances may trigger unwanted inflammation which accelerates telomere attrition."

Source: Cell Science Systems, alcat.com

Released: 12/03/14

"Lifestyle Medicine" Deemed a Key Component of Successful Cancer Care

A growing body of scientific evidence now confirms what physicians and staff at Loma Linda University Medical Center’s James M. Slater, MD, Proton Treatment and Research Center have known for a quarter century: The practice of lifestyle medicine is vital in the successful treatment of cancer and other diseases.

Lifestyle medicine includes such interventions as stress management, nutrition, exercise, social networking, and spiritual support. This approach has been a key component of the healing process and is presented to all patients who receive proton radiation therapy at Loma Linda University Medical Center (LLUMC).

“Once proton treatment has concluded, we provide our patients with a comprehensive cancer survivorship plan and give them targeted tools, techniques, and the support they need to live a healthy and fulfilling life,” said Carol Davis, PsyD, DrPH, RTT, education program director for the department of radiation medicine at LLUMC. As an example, Davis points to the “Passport to Wellness” program at Loma Linda, which focuses on each patient’s specific situation. A tailored nutrition and exercise program is provided, exclusively geared to the patient’s long-term success.

Lifestyle medicine is one part of LLUMC’s overall philosophy of care. That philosophy begins at the time of diagnosis and centers around treating the “whole person,” including the myriad of physical, psychological, and spiritual needs that are essential to healing. Every aspect of healthy living is presented to LLUMC patients as they learn that healing comprises many components, from nutrition to physical activity to social networking to spiritual support.

To ensure that the healing process continues and the risk of cancer recurrence is reduced, patients are actively encouraged to continue practicing what they have learned about exercise, nutrition, stress reduction, and gathering social support after they complete their treatment at LLUMC.

“After a comprehensive assessment of an individual’s lifestyle and body composition, our preventive care specialists devise a behavior-modification program and meet with individuals monthly to talk, reassess, and plan for continued success in our program,” said Hildemar Dos Santos, DrPH, professor of preventive care at LLUMC. “The program is designed to help patients get back to normal as quickly as possible, while at the same time improving their quality of life.”

Modern medical practices, including the proton radiation therapy available at LLUMC, have led to a growing population of cancer survivors around the country. Survivors now number more than 13 million, or 1 in 25 Americans. Lifestyle choices such as health-supportive nutrition, maintaining a healthy weight, regular physical activity, stress management, group support, and spirituality are increasingly being shown to help prevent recurrent cancer and the development of new cancers. The same practices also may help prevent and treat many other common medical conditions.

Source: Loma Linda University Medical Center, lomalindahealth.org

Released: 12/02/14

Even Mild Coronary Artery Disease Puts Diabetic Patients at Risk

According to a new long-term study, diabetic patients with even mild coronary artery disease face the same relative risk for a heart attack or other major adverse heart events as diabetics with serious single-vessel obstructive disease. Results of the study were presented today, December 2, 2014, at the annual meeting of the Radiological Society of North America (RSNA).

AT A GLANCE:

Diabetic patients with mild coronary artery disease are at increased risk for heart attack, a long-term study of 1,823 people shows.

Previously, these patients were thought to have a lower risk of major adverse cardiovascular events and death than patients with obstructive coronary artery disease.

Cardiac CT angiography is helpful for identifying diabetic patients who are at higher risk for heart events.

Researchers at the University of British Columbia and St. Paul's Hospital in Vancouver analyzed data from the Coronary CT Angiography Evaluation For Clinical Outcomes: An International Multicenter (CONFIRM) Registry, which was developed to examine the prognostic value of cardiac computed tomography angiography (CCTA) for predicting adverse cardiac events related to coronary artery disease. The registry, which has CCTA data on 40,000 patients from 17 centers around the world, now has five-year follow-up data on 14,000 patients.

"The CONFIRM Registry is the largest long-term data set available and allowed us to evaluate the long-term prognostic value of CCTA in diabetic patients," said study co-author Jonathan Leipsic, MD, vice chairman of the Department of Radiology at the University of British Columbia.

The researchers analyzed data on 1,823 diabetic patients who underwent CCTA to detect and determine the extent of coronary artery disease, in which a waxy substance called plaque builds up inside the arteries of the heart. This plaque buildup causes the artery wall to thicken, which limits or, in some cases, completely obstructs blood flow.

Men and women (median age 61.7) in the study were categorized as having no coronary artery disease, mild disease (less than 50 percent of coronary artery narrowed), or obstructive disease (more than 50 percent artery obstruction). Over a 5.2-year follow-up period, there were 246 deaths, representing 13.5 percent of the total study group.

Major adverse cardiovascular event (MACE) data was available on 973 patients. During the follow-up period, 295 (30.3 percent) of the patients experienced a MACE, such as heart attack or a procedure to re-open an obstructed artery called a coronary revascularization.

The researchers found that both obstructive and mild, or non-obstructive, coronary artery disease as determined by CCTA were related to patient deaths and MACE. Most importantly, the study found that the relative risk for death or MACE for a patient with mild coronary artery disease was comparable to that of patients with single vessel obstructive disease.

"Until now, two-year follow-up studies suggested that a diabetic patient with mild or non-obstructive coronary artery disease had a lower risk of major adverse cardiovascular events and death than patients with obstructive disease," said co-author Philipp Blanke, MD, radiologist at the University of British Columbia and St. Paul's Hospital. "Our five-year follow-up data suggests that non-obstructive and obstructive coronary artery disease as detected by cardiac CTA in diabetic patients are both associated with higher rates of mortality."

Dr. Leipsic said researchers need a better understanding of the evolution of plaque in the arteries and patient response to therapies.

"Cardiac CT angiography is helpful for identifying diabetic patients who are at higher risk for heart events, who may benefit from more aggressive therapy to help modify that risk," added Dr. Leipsic.

Source: Radiological Society of North America (RSNA), rsna.org

Released: 12/02/14

CollPlant Launches Clinical Trial for the Treatment of Chronic Wounds

CollPlant, a developer and manufacturer of human collagen-based medical products, announced that it has enrolled and treated the first patient in its VergenixFG clinical trial in Israel.

The VergenixFG gel is an advanced gel formulation based on rhCollagen, intended for chronic wounds including diabetic foot ulcers, pressure and venous ulcers, and surgical and trauma wounds. The product is based on a human collagen produced in tobacco plants using a patented technology owned by

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