Past News Items - May 2012

A recent placebo-controlled study reveals new evidence of trans-cranial bright light's effect to brain functions when administered through the ear. Bright light stimulation was found to increase activity in brain areas related to processing of visual sensory information and tactile stimuli. The findings constitute the first ever published scientific article about functional modulation of the brain with bright light delivered to the brain through the ears. The study was published today May 29th, 2012 in the World Journal of Neuroscience.

"The research results confirm that it is possible to influence brain functions with bright light delivered directly to the brain through the ear," says researcher TuomoStarck from the Oulu University Hospital. "The group that received bright light demonstrated in the analysis significant increase in neural network activity especially in brain areas connected with visual perception."

The study was conducted with 51 healthy test subjects, utilizing functional magnetic resonance imaging (fMRI). Some of the test subjects were given bright light into the ear canals with an optical fibre, and for others the light source was switched off. The eyes of the test subjects were covered during the study so that they were unable to determine which group they belonged to. Optical fiber did not warm up from the influence of light. The study setting was typical for brain imaging, and corresponds with a placebo controlled setting. Real time functions of the brain's resting state neural networks were measured in the study with fMRI, making it possible to locate the regions of the brain where the amount of blood and its oxygen saturation change as a result of intervention; in this case as a result of bright light.

"There is earlier proof of the existence of photosensitive proteins, such as opsins, in the brain. This study confirms light-responsiveness of the brain itself, and that bright light given through the ear canal is a very viable method for influencing mood," says Professor and Leading Senior Physician Timo Takala from Oulu Deaconess Institute.

According to a second, closely related research result by Oulu University researchers, presented in March at the European Congress of Psychiatry, the human brain contains large amounts of photosensitive OPN4 (melanopsin) receptor protein. The clinical efficacy of bright light therapy for mood disorders when administered through the eye is believed to be based on the photosensitive OPN4-protein that has earlier been found only on the retina.

"Discovery of the photosensitive OPN4-protein in several parts of the human brain adds to the body of evidence that bright light channeled to the brain directly - and not only through the eyes - increases the activity of brain functions," comments Chief Science Officer Juuso Nissilä from the Finnish company Valkee Oy.

Bright light is widely recognized as an effective therapy for treating Seasonal Affective Disorder. The Valkee bright light headset is based on the latest research findings regarding photosensitivity of the brain: bright light is channeled through the ear canal directly to those brain areas that are known to be central in depression, and that have been discovered in studies at the Oulu University to contain photosensitive proteins.

A link to the article: http://www.scirp.org/journal/PaperInformation.aspx?paperID=19417

Released: 05/30/12

New Research Suggests Novel Insulin Sensitizer Works Through a New Mechanism to Treat Root Cause of Type 2 Diabetes

Washington University School of Medicine researchers show MSDC compound has anti-diabetic efficacy without side effects profile of current drugs to treat insulin resistance

A study published online in the Journal of Biological Chemistry (jbc.org/content/early/2012/05/23/jbc.M112.363960) showed a new drug to treat diabetes being developed by Metabolic Solutions Development Company, LLC (MSDC), MSDC-0602, improved insulin resistance and inflammation in obese mice. These findings by researchers at Washington University School of Medicine, in collaboration with colleagues at the University of Michigan and MSDC, suggest that MSDC-0602, a novel anti-diabetic drug which is in Phase 2 clinical trials, may constitute the first in a class of next generation insulin sensitizers that appear to work through a new biochemical mechanism to treat insulin resistance and type 2 diabetes.

"Currently-approved insulin sensitizing drugs are effective but their use is limited by side effects believed to be caused by the over-activation of the peroxisome proliferator-activated receptor gamma (PPARg)," said Brian N. Finck, PhD, Research Assistant Professor in Medicine, Division of Geriatrics & Nutritional Science, Washington University School of Medicine. "Our findings provide the framework for the discovery and development of a new class of insulin sensitizers that can operate independent of the activation of PPARg."

Previously, it was believed that both the anti-diabetic activity and the side-effects of these agents were mediated through activation of a nuclear receptor called PPARg. However, it is now generally accepted that over-activation of PPARg drives the unwanted and often unacceptable side effects associated with the currently-approved insulin sensitizers, which are PPARg agonists, and emerging evidence suggests that the potent anti-diabetic efficacy can be separated from the ability to activate PPARg. Some, including MSDC researchers, have suggested that key aspects of the insulin sensitizing actions remained to be identified.

"Having been among the original workers in this field, we have long been skeptical of the PPARg hypothesis as an explanation for all of the actions of the insulin sensitizers and have been concerned the singular pursuit of compounds that activate PPARg has hampered the development of safe, effective, and durable treatments for insulin resistance," said Jerry Colca, PhD, president, chief scientific officer and co-founder of MSDC. "The work of Dr. Finck and his colleagues affirms our goal to understand this important pharmacology in a way that will allow the development of new therapeutic agents to improve treatment outcomes for patients with type 2 diabetes."

This study, titled "Insulin Resistance and Metabolic Derangements in Obese Mice are Ameliorated by a Novel Peroxisome Proliferator-Activated Receptor g-sparing Thiazolidinedione," evaluated MSDC-0602 for its effects on insulin resistance in obese mice. These researchers found that MSDC-0602 markedly improved several measures of multi-organ insulin sensitivity, fat tissue inflammation, and metabolic disturbances in the liver including suppressing fat and glucose production, which are increased in diabetic liver cells. These beneficial effects were mediated, at least in part, via direct actions on liver cells and were preserved in liver cells lacking PPARg, indicating that PPARg was not required to suppress the formation of fat and glucose.

The study was conducted by the Department of Medicine at Washington University School of Medicine and the Department of Internal Medicine at the University of Michigan, in collaboration with scientists at MSDC.

MSDC is developing two novel compounds to treat type 2 diabetes that are intended to improve the body's sensitivity to insulin (which moves blood sugar (glucose) into cells, where it is stored and later used for energy), lower the percent of calorie-storing "white" fat, increase the production of calorie-burning "brown" fat, preserve the function of pancreatic beta cells (which produce insulin), and possibly protect neurons in the brain (which could be important in treating diseases such as Alzheimer's and Parkinson's disease).

Phase 2b results for MSDC-0160, a novel once-a-day oral insulin sensitizer, will be presented June 9, 2012 at the 72nd Scientific Sessions of the American Diabetes Association (Abstract #996-P). MSDC previously reported results from a Phase 2a study of MSDC-0602, a second novel once-a-day oral insulin sensitizer, which showed the potential of that agent to achieve significant glucose control, reduce HbA1c, and increase insulin sensitivity in type 2 diabetes patients.

Released: 05/29/12

New Wellness Team Approach Improves Diabetes Outcomes while Lowering Medication Costs

An integrated wellness team approach to diabetes care is helping patients lower their prescription costs and improve their condition, according to research presented today at the American Association of Clinical Endocrinologists’ (AACE) 21st Annual Scientific & Clinical Congress in Philadelphia.

Researchers John Gary Evans, MD, et al noted that by participating in this program, patients were able to decrease their doses of insulin and oral medication, on average, by 46 percent and 12 percent, respectively. In addition, on average, patients were able to reduce their 30-day prescription costs by nearly $143 per month. Participants also decreased their body mass index (BMI) by 3.07 and hemoglobin A1c (HgA1c) by 0.7 percent. HgA1c was reduced by an average of 1.3 percent for patients with a baseline HgA1c of 8 percent or more.

“These results demonstrate that engagement leads to a greater understanding of a healthier lifestyle,” said Dr. Evans, lead author on the study.

The program, developed by Dr. Evans’ Jacksonville-based endocrinology group, enrolled adult patients with type 2 diabetes in an intensive wellness program that addressed multiple aspects of diabetes care. Patients were counseled in nutritional, fitness, and behavioral elements of diabetes management in a customized 16-week curriculum while their doctors monitored BMI, weight, HgA1c levels and diabetes medication dependence. Medications were reduced as needed to reduce the risk of low blood sugars. The group strived to improve diabetes outcomes and reduce complications and expenditures by tailoring the approach to each patient.

“The multi-disciplinary program creates a timeframe that gives patients time to absorb the information, revisit strategies for management and engrave the behaviors into their minds,” explains Dr. Evans. “Covering those key elements is what it takes for patients to grasp and embrace the strategies to be successful and improve their condition.”

In November 2011, the Centers for Medicare and Medicaid (CMS) ruled that intensive behavioral therapy for obesity is covered as a benefit under some Medicare plans. Dr. Evans says that he hopes the success of this program will illustrate the need for lifestyle intervention and wellness training as part of comprehensive care plans for all diabetes patients.

“It is our hope that the success of this curriculum will create a pathway for intensive wellness programs to be recognized as medical benefits for diabetes patients by insurance companies,” said Dr. Evans. “The only way to be successful with long-term goals is to affect a lifestyle change.”

To read additional press releases about the AACE 21st Annual Scientific & Clinical Congress in Philadelphia, please visit media.aace.com. or follow the Twitter hashtag #AACE2012.

For a brief bio and photo of Dr. Evans, please click here.

Released: 05/22/12

Light-Responsive Melanopsin Found in Many Parts of the Human Brain

More evidence of the effectiveness of bright light directed at the brain

A new study by Oulu University found large amounts of a light-sensitive OPN4-protein, melanopsin, in the human brain. The mood-enhancing influence and circadian pacemaking properties of bright light when administered through eyes has been shown in earlier studies to be based on the OPN4-protein. In those studies the protein was found only on the retina. This new discovery now confirms that bright light, when channeled through the ear canal into the brain, can have an influence on brain functions.

The study, done at Oulu University, was presented in March at the European Congress of Psychiatry in Prague. The OPN4-protein was originally discovered in 2000 when it was found on the retina. In the more recent study at Oulu University the same protein was found in all the 17 sites of the human brain that were being studied. The presence of the protein was confirmed using methods of molecular biology.

"The discovery of the research team confirms that some of the brain cells may be photosensitive. OPN4-protein, also known as melanopsin, is present in brain cells that have a central role in modulation of several vital functions, including the circadian rhythm", says Professor Seppo Saarela of the Oulu University biology department, who led the study. "Often findings of even classical status are worth re-confirming with additional measurements by several research groups, utilizing improved methods. The present study succeeded in locating melanopsin despite the negative results by the earlier studies. Never before have these measurements been completed on as much human samples as was used in the study now reported", emphasizes Saarela.

The new research findings are supportive of effects of bright light therapy administered directly into the brain through the ear canal.

"Discovery of the photosensitive OPN4-protein in several parts of the human brain adds to the body of evidence that bright light channeled to the brain directly—not just through the eyes—can modulate brain functions", says Chief Science Officer Juuso Nissilä from Finnish company Valkee Oy. The molecules of the opsin family are extremely sensitive to quantities of light that have been already shown in studies decades ago to penetrate all the way into central parts of the brain", he emphasizes.

Bright light is widely recognized as an effective therapy for treating Seasonal Affective Disorder. The Valkee bright light headset is based on research findings on photosensitivity of the brain: light is channeled through the ear canal directly to regions of the brain that are known to be central to depression and that have been discovered to contain photosensitive proteins in studies at the Oulu University. Already earlier, in 2011, a research group in Oulu found a photosensitive OPN3-protein (encephalopsin, panopsin) in the human brain.

Valkee Oy is a health technology company founded in 2007, that has developed a bright light headset device for treatment of Seasonal Affective Disorder. The knowhow of the company is based on long term scientific research and development work together with the Oulu University. For more information on Valkee Oy see http://www.valkee.com or Valkee Facebook-pages http://www.facebook.com/ValkeeCompany

Released: 05/21/12

Nature Neuroscience Study Shows Unique Scientific Support for Potential New Myelin Repair Treatment for Multiple Sclerosis

Funded by the Myelin Repair Foundation, Study Conducted by Case Western Reserve University Scientists Find Improvement with Mesenchymal Stem Cell Signals in Animal Models of Multiple Sclerosis

The Myelin Repair Foundation (MRF) today announced the results of a new peer-reviewed research study published in Nature Neuroscience that demonstrates functional improvement in immune response modulation and myelin repair with factors derived from mesenchymal stem cell (MSC) treatment in animal models of multiple sclerosis (MS). Funded by the Myelin Repair Foundation, this research conducted by Case Western Reserve University scientists showed positive results with human mesenchymal stem cells in animal models of MS by not only successfully blocking the autoimmune MS response, but also repairing myelin, demonstrating an innovative potential myelin repair treatment for MS.

Multiple sclerosis is a disease of the immune system that attacks the myelin, causing exposed nerves or “lesions” which block brain signals, causing loss of motor skills, coordination and cognitive ability. Compared to the controls, this research study showed fewer and smaller lesions found on the nerves in the MSC treatment group.

MSCs were found to block the formation of scar tissue by suppressing the autoimmune response, which would otherwise cause permanent damage to the nerves. Furthermore, the research showed that MSC treatment also repaired myelin, enhancing myelin regeneration of the damaged axon and the rewrapping of the myelin around the axon in animal models of MS. One treatment of MSCs provided long-term protection of the recurring disease.

Led by Myelin Repair Foundation Principal Investigator and Vice President for Research & Technology Management at Case Western Reserve University’s Dr. Robert Miller, this study documents a new promising pathway for treating multiple sclerosis that blocks the autoimmune response and reverses the myelin damage in animal models of MS. The human MSCs used in this study were culled from adult stem cells derived from the bone marrow.

“We are thrilled with the publication of this important research study that examines a new pathway to treat multiple sclerosis, one that reverses the damage of the disease,” said Dr. Robert Miller. “Since we were just beginning to understand how MSCs provide myelin repair for lesions, with the Myelin Repair Foundation’s support, we continue to deepen our knowledge of exploring the next generation of MS treatments that stimulate healing, rather than symptom suppression of the disease.”

“We pride ourselves on supporting best-in-class scientists devoted to find new ways to treat multiple sclerosis, advancing highly innovative research projects that otherwise would not have moved forward,” said Scott Johnson, president of the Myelin Repair Foundation. “The success of Case Western Reserve University’s study and recognition in this prestigious journal furthers our goal to identify new pathways to treat multiple sclerosis by supporting a multi-disciplinary team of the best researchers in the field.”

About the Myelin Repair Foundation
The Myelin Repair Foundation (MRF) (myelinrepair.org) is a Silicon Valley-based, non-profit research organization focused on accelerating the discovery and development of myelin repair therapeutics for multiple sclerosis. Its Accelerated Research Collaboration (ARC) model is designed to optimize the entire process of medical research, drug development and the delivery of patient treatments.

Released: 05/18/12

2012 Sound Healing Retreat Immersion

June 20 – 23, four of America’s foremost experts in the art and science of sound healing will lead the 2012 Sound Healing Retreat Immersion. This intensive four-day program is ideal for experienced sound healing professionals, holistic practitioners who wish to introduce sound healing in their practices, and those who seek personal transformation through the miracle of sound.

The internationally renowned faculty includes Dr. John Beaulieu, Dr. Zacciah Blackburn, Dr. Mitch Nur, and Philippe Garnier. This intensive retreat experience also features special presentations by Grandmother Barbara Threecrow, Lisa Rafel, and Steven and Gina Bachmann. The 2012 Sound Healing Retreat Intensive builds on the success of the 2011 event, also held at the Menla Mountain Retreat, located in Phoenicia, NY, 20 minutes from Woodstock. View a video presentation of the 2011 event: www.soundhealingretreat.com

A certification of completion, signed by all retreat faculty members, will be awarded to participants who complete this training in sound healing. The course will be of specific interest to naturopathic and osteopathic doctors, chiropractors, acupuncturists, and other professionals in the field of complementary and alternative medicine. The program will include instruction on how to structure and conduct a Healing Sound Session with a client, providing insight into how to recalibrate and realign the energy centers of the body through the use of sound.

“Sound Healing improves and transforms a range of physical and emotional states. It is especially effective for those with chronic illness, allergies, and compulsive behavioral patterns, or who are recovering from trauma and grief,” says sound healer, teacher, and retreat organizer Philippe Garnier. Sound healing has been clinically shown to support people suffering from stress related disorders and chronic pain, as well as patients undergoing cancer treatments.

Under the guidance of these remarkable scholars, doctors, healers, and musicians, students will explore the healing potential of tuning forks, crystal and Tibetan singing bowls, indigenous horns, voice, drums, and other percussion instruments. Participants will learn the therapeutic application of these tools to create sacred space, shift and expand consciousness, address a range of physical conditions, restore balance, and promote positive change at the cellular level.

Highlights of the retreat: John Beaulieu, ND, PhD on using BioSonic Fibonacci tuning forks in order to induce altered states of consciousness that empower creative visions and help people work through dependencies and addictions. Zacciah Blackburn, PhD, introduces students to the vibrational aspect of all living things through shamanic and classical healing techniques. The leading scholar in Himalayan and Tibetan Singing Bowls, Mitch Nur, PhD, shares the history, myth, and practical use of these ancient instruments. Philippe Garnier offers a session on how one can use crystal healing bowls in one’s healing practice focusing on how sound, prayers, and intention create extraordinary changes in both body and consciousness.

“Participants will experience profound personal transformation as a result of being surrounded with these healing frequencies so completely for these four unparalleled days,” says Garnier. “To have the opportunity to study with these teachers in this intensive retreat on the sacred and already energetically charged land of will be unique experience that will stay with them forever. Everyone will leave the retreat with precious and practical skills that they can immediately use both to enhance their own individual growth and benefit their clients.”

Tuition for commuters begins at $994 (cost includes three meals per day). Rates for those who stay at Menla range from $1042 to $1481. One-day registration rates begin at $269 per day. Visit soundhealingretreat.com for payment and accommodations details.

Menla House is conveniently located less than 10 miles from Woodstock and is easily accessible to residents of the Hudson Valley and Catskills area. Phoenicia, NY is two hours north of New York City (three hours by the Adirondack Trailways Busline) and three and a half hours from Boston. The retreat center is an hour from both the Albany and Steward (Newburgh, NY) airports. For further information on directions and transportation to Menla House please visit: menla.org/Menlalocation.html.

Released: 05/18/12

UTEP and Premier Biomedical to Collaborate on Cancer, Alzheimer’s and Brain Injury Research

The University of Texas at El Paso and Premier Biomedical, Inc. (OTCBB:"BIEI") have signed a collaboration agreement to conduct joint research of Premier’s sequential-dialysis technique, a method for the removal of harmful molecules that cause diseases.

The research projects will use Premier Biomedical, Inc's. patent-pending technology to "Remove the Pathophysiologic Basis of the Disease" developed by its co-founder, Dr. Mitchell S. Felder.

The team will concentrate initially on developing treatments for traumatic brain injury, cancer, and Alzheimer's disease, said Robert Kirken, PhD, professor and chair of biological sciences at UTEP.

“The goal is to try to remove unwanted proteins or molecules that exacerbate or cause the disease state,” Kirken said. “With UTEP’s technology, coupled with the support of Premier Biomedical, we may be able to address these human diseases.”

Researchers in UTEP’s $45 million state-of-the-art Border Biomedical Research Center (BBRC) will test Premier’s patents inside the BBRC’s six core laboratories, which allow faculty to conduct vital research using advanced technology.

The Analytical Cytology lab provides UTEP scientists with advanced instrumentation to study cell structure, function and disease state.

The Bioinformatics Computing lab offers high performance computing capabilities to support computer modeling and database development.

The Cell Culture and High Throughput Screening (HTS) Core lab is a comprehensive research facility that provides investigators with advanced technology to conduct cell-based experiments and test a large number of compounds against cancer, pathogens, and other diseases.

The DNA Analysis Core Facility supports UTEP researchers in their nucleic acid-based research studies such as sequencing, typing and fingerprinting. The Statistical Consulting Lab provides BBRC faculty with statistical and computing support.

Biomolecule Analysis lab supports scientists by specializing in the separation and characterization of biomolecules.

"The agreement with UTEP offers an optimum synergistic relationship where the vast intellectual capabilities of the University will facilitate more rapid product development and reduce time-to-market for our technology,” said William A. Hartman, President, CEO, and co-founder of Premier Biomedical, Inc. “Using the University’s facilities to conduct the necessary research on our initial products is a tremendous benefit to this company and its shareholders. The initial focus of the team on traumatic brain injury, cancer, and Alzheimer's disease has immediate potential to finally develop a badly needed cure for these dreaded diseases for all humanity."

UTEP graduate and undergraduate students also will be trained in these new therapeutic strategies to help fight and combat human disease, helping to boost UTEP’s bid to become a national research university with a 21st century demographic.

Established in 1992, with support from the Research Centers in Minority Institutions (RCM) and the National Institutes of Minority Health Disparities (NIMHD), the BBRC addresses health issues relevant to the population along the U.S.-Mexico border.

Premier Biomedical, Inc. is located in Port Richey, Fla. and also has operations in Jackson Center, Penn. More information about Premier Biomedical, Inc. and its revolutionary technology can be found on the company’s web site at premierbiomedicalinc.com.

Released: 05/17/12

Folic Acid Essential for Prenatal Health, No Matter the Form

The bioavailability of folic acid does not significantly differ between delivery in standard tablet or softgel capsule forms, according to research published in this month's Journal of the Academy of Nutrition and Dietetics. Folic Acid helps support a women's pregnancy and development of a healthy newborn.

"This research provides important information to health professionals who treat women of childbearing age. Because half of all pregnancies are unplanned(1), intake of folic acid should be part of the daily routine for many women and this research helps to reduce barriers for its intake through supplements," said Louis I. Ndife, DVM, PhD, Director of Medical and Scientific Affairs at Pharmavite LLC. The folic acid tablets and prenatal multivitamins with DHA softgels used in the study were manufactured by Pharmavite LLC., makers of Nature Made vitamins.

Absorption of Folic Acid from a Softgel Capsule Compared to a Standard Tablet
This randomized crossover study evaluated the bioavailability of folic acid from a multivitamin softgel capsule vs. a folic acid tablet in 16 premenopausal women (18-45 yr of age). Participants were randomly assigned to receive a single dose of ~1000 mcg folic acid in two tablets or ~1000 mcg folic acid in a multivitamin softgel capsule, and then crossed over to receive the other study product ~one week later. Blood samples were collected pre-dose (0 hr) and 1, 2, 3, 4, 6 and 8 hr post-dose for serum folate analysis. The study results showed apparent bioavailability of folic acid was similar for the folic acid tablets and a multivitamin softgel capsule.

There were no significant differences between folic acid tablets and multivitamin/mineral softgel capsules for serum folate net incremental areas under the curve (niAUC 0-8 hr), total areas under the curve (AUC 0-8 hr) or maximum concentrations (C max). There was an apparent delay in absorption of folic acid from the softgel capsule compared with the tablets, but this difference is likely clinically insignificant in the context of long-term nutrition.

The study concluded that serum folate AUC 0-8 hr and C max were similar for a multivitamin/mineral supplement with folic acid in a softgel capsule when compared to a similar formulation in tablet form, although the timing of absorption appeared to differ, with the peak folate concentration occurring later after capsule ingestion. In the context of long-term nutrition, this difference in rate of absorption will likely be of little consequence.

Importance of Folic Acid
An estimated 3,000 pregnancies each year in the United States are affected by neural tube defects (NTDs), which are serious birth defects of the spine (spina bifida) and brain (anencephaly). However, consumption of the B vitamin folic acid prior to conception can reduce the occurrence of NTDs by up to 70%.

Because of this, both the US Public Health Service and Institute of Medicine issued recommendations that all women capable of becoming pregnant consume 400 mcg of folic acid daily. Additionally, the Food and Drug Administration mandated fortification of cereal grain products with folic acid to increase women's daily intake.

While this fortification of the US food supply resulted in a 26 percent reduction in NTDs, many women still do not receive adequate levels of folic acid from their diets. This has been particularly pronounced in the past decade, as many women of childbearing age follow low-carbohydrate weight loss diets, which limit many of the fortified foods. Therefore, increasing the use of vitamins containing folic acid remains an integral component of NTD prevention.

Released: 05/16/12

Juventas Therapeutics Enrolling Patients in Phase IIa STOP-CLI Clinical Trial

Juventas Therapeutics, a privately-held, clinical-stage company developing novel regenerative therapies for treatment of cardiovascular disease, is pleased to report that it is actively enrolling patients in a placebo-controlled, randomized double-blinded Phase IIa study evaluating the safety and efficacy for JVS-100 in patients with Rutherford Class 4 or 5 critical limb ischemia (CLI). JVS-100, the Company's lead product, encodes Stromal cell-Derived Factor 1 (SDF-1) which has been shown to repair damaged tissue through recruitment of circulating stem cells to the site of injury, prevention of ongoing cell death and restoration of blood flow.

Patients are enrolling at Northwestern Memorial Hospital, Cardiology PC, Minneapolis Heart Institute Foundation, and Summa Health Systems. In addition, the Company is enrolling patients at three leading cardiovascular institutions in India; Medanta the Medicity, Sir Ganga Ram, and Fortis Escorts Heart Institute.

"We are excited to be participating in the STOP-CLI trial," says Melina Kibbe, MD, principal investigator for the study and the Edward G. Elcock Professor of Surgical Research at the Northwestern University School of Medicine. "CLI is a devastating disease for which there are no good therapeutic options. JVS-100 is a regenerative therapy with the potential to improve clinical outcomes for these patients."

There are an estimated 3 million Americans suffering with CLI. The prognosis for these patients is 25 percent mortality and 35 percent major amputation rates within a year of diagnosis.

"Juventas is committed to developing novel regenerative therapies for life-threatening cardiovascular diseases," states Rahul Aras, PhD, President & CEO for Juventas Therapeutics. "The initiation of this trial, with top-tier clinical centers, represents an exciting milestone for the Company."

The STOP-CLI Trial
The STOP-CLI Trial (Sdf-1 plasmid Treatment fOr Patients with Critical Limb Ischemia) is a dose-ascending, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of JVS-100 treatment in patients with Rutherford class 4 or 5 CLI.

Patient outcome measures include safety, time to amputation, wound closure, TcPO2, ankle-brachial index (ABI) and toe-brachial index (TBI)

About Juventas Therapeutics
Juventas Therapeutics, headquartered in Cleveland, OH, is a privately-held clinical-stage biotechnology company developing a pipeline of regenerative therapies to treat life–threatening diseases. Founded in 2007 with an exclusive license from the Cleveland Clinic, Juventas has transitioned its therapeutic platform from concept to initiation of mid-stage clinical trials for treatment of heart failure and critical limb ischemia. Investors include New Science Ventures, Takeda Ventures, Triathlon Medical Venture Partners, Early Stage Partners, Fletcher Spaght Ventures, Reservoir Venture Partners, North Coast Angel Fund, X Gen Ltd., JumpStart Inc., and Blue Chip Venture Co. The company has received non-dilutive grant support through the Ohio Third Frontier funded Cleveland Clinic Ohio BioValidation Fund, Global Cardiovascular Innovation Center and Center for Stem Cell & Regenerative Medicine.

For more information, visit juventasinc.com.

Released: 05/09/12

Sports-Related Concussions Topic of June Brain Health Conference

Leading brain health experts to present cutting edge research, protocols

Nordic Naturals, industry leader in omega-3 oils, in partnership with the Brain Health Education and Research Institute (BHERI), announces the 2012 Research and Education Conference "Advances in the Prevention and Management of Sports-Related Concussions" set for June 8-9 at the Bethesda Marriott in Bethesda, MD.

Noted experts from diverse fields including academia, professional sports and government will present cutting-edge research, new clinical evidence and advances in treatment regarding the critically important area of preventing, assessing, treating and managing sports-related concussions. Speakers include Joseph Hibbeln, MD; Michael Lewis, MD; Victor Coronado, MD; Julian Bailes, MD; John Norwig, ATC; Joseph Maroon, MD; Hee Yong Kim, PhD; and, Tim Walilko, PhD.

"According to the CDC, as many as 3.8 million sports- and recreation-related concussions occur in the United States each year," noted Keri Marshall, MS, ND, Nordic Naturals' Chief Medical Officer. "This conference is a premier educational event for health care professionals, athletic trainers, coaches, and military officers who want to learn the current recommendations for prevention, assessment and treatment of concussions and brain injury."

Michael Lewis, MD, founded BHERI following a career in the Army where he spearheaded the use of omega-3s for traumatic brain injury. "I started the Institute to educate people about the power of omega-3s in the prevention and treatment of concussions," Lewis said. "Partnering with Nordic Naturals has been a great fit for us because of our shared passion to see continued research and education about omega-3s and brain health." More information about the Institute can be found at brainhealtheducation.org.

Cost of the conference is $75. Attendees will receive a $75 voucher for Nordic Naturals professional products and a free Holman Omega-3 Blood Spot Home Test Kit. Members of the military, government employees and members of the press may attend at no cost, but are required to register. Continuing education credits will be offered for athletic trainers.

For complete speaker profiles, agenda and registration information, see nordicnaturals.com/DC.

Released: 05/08/12

WilloMD Announces Plans to Take One Billion Pain Pills Off the Street

Millions suffering from addiction and joint pain have hope with new digital smart technology

Physician's Technology announced new computerized digital joint pain relief technology may take one billion pain pills off the street. Millions suffer from joint pain and arthritis, often pushing them to the brink of addiction to pain pills. Government sources report that over 1.7 million Americans 12 and older are addicted to pain medication and thousands die each year. In desperation, many give in to pain pills. As baby boomers age, joint pain and arthritis are a growing problem.

The inspiration for the "Pain Pill Challenge" as a National initiative is to bring awareness to this growing health problem. It includes hands-on demonstrations around the country introducing new digital smart joint pain management technology called the WilloMD.

At the events, the firm's medical team invites unscripted audience participation and WilloMD demonstrations. As the audience looks on, most report measurable joint pain relief and greater mobility. It offers a convenient in-home drug-free alternative, saving time and money spent for repeated office visits.

WilloMD is like a GPS for joint pain. In youth, wear and injury trigger toxicity and inflammation, activating the immune system to help repair and promote healing. With age, and increased damage, this repair process slows and toxicity can accumulate, damaging cartilage, soft tissue and meniscus. This is known as Toxic Joint Syndrome. The WilloMD gives the user a boost similar to when they were younger. Thousands, including the Navy Seals, have taken the Pain Pill Challenge and discovered the WilloMD.

David B. Sutton, CEO, commented, "This is an exciting healthcare paradigm shift with a high-tech tool for joint pain relief. Some joint conditions may respond to more conventional approaches. The 'Pain Pill Challenge' could be visiting your town; e-mail us at [email protected] or send a tweet at @willomd. We are glad to be a part of such a massive and positive movement. It's free and all you have to lose is your joint pain."

Released: 05/07/12

Do You Have Patients That Suffer from Migraines?

Online Migraine Trial Available

Quincy Bioscience is enrolling migraine sufferers who experience at least three migraines per month into a three month in a dose ranging study of an apoaequorin-based supplement.

This randomized controlled trial will be conducted completely online. There is no travel required! Quincy Bioscience has pioneered "distance studies" using validated patient-rated outcomes assessments.

To read more about Quincy Bioscience, visit QuincyBioscience.com. To apply for the online migraine trial, visit onlinemigrainetrial.org.

Released: 05/07/12

New Findings of Daily Consumption of Soy Isoflavones and Cacao-Flavonoids in Diabetes Type 2 Patients

A new, one-year, double-blind controlled clinical study shows that cacao-flavonoids and soy isoflavones can significantly improve biomarkers of CVD risk in postmenopausal women with type 2 diabetes.

The trial, conducted by Peter J. Curtis, PhD, et al, funded by a UK based Charity, Diabetes UJK, and supported by Frutarom Ltd., Israel, and Barry Callebaut, the world's leading manufacturer of high-quality cocoa and chocolate products, was published February, 2012, in Diabetes Care. The purpose of the study was to assess the effect of dietary flavonoids on cardiovascular disease (CVD) risk in postmenopausal women with type 2 diabetes on established statin and hypoglycemic therapy.

The clinical trial consisted of 93 medicated postmenopausal women with type 2 diabetes. Subjects were randomly allocated to consume 27 g/day (split dose) of flavonoid-enriched chocolate (Barry Callebaut ACTICOA chocolate containing 850 mg flavan-3-ols [90 mg epicatechin] and 100 mg of isoflavones [aglycone equivalents)]/day) or a matched placebo.

At the conclusion of this trial, the combined one-year intervention with flavan-3-ols and isoflavones resulted in a significant improvement in biomarkers of CVD risk in postmenopausal type 2 diabetic patients, compared to placebo. These data highlight the additional benefit of dietary flavonoids to standard drug therapy in managing CVD risk in this group of patients.

"We are incredibly happy with the new study results showing that the soy isoflavones in SoyLife, produced by Frutarom, in combination with cacao-flavonoids could help decrease CVD risk," says Mira Koppert, Manager of the LifeLine brand extension at Frutarom. "We anticipate these outstanding findings will open new opportunities in marketing SoyLife to supplement makers and food processors and position it as the leading soy isoflavones source in the global market."

SoyLife has been included in more than 35 proprietary studies in the fields of menopause, bone health, heart health, and cognitive function. "SoyLife stands out in the market in comparison to other soy isoflavones, not only due to its extensive research but also because it is a natural, multi-component ingredient, derived from soy germ, containing not just soy isoflavones but also vitamin E, antioxidants, fibre and many others," explains Mira Koppert. "These factors and the typical soy germ isoflavone profile of genistein : daidzein : glycitein, which is 15 : 50 : 35 indicate SoyLife is a perfect solution to obtain the health effects associated with soy." SoyLife is available in concentrations ranging from 3% to 40% and can be used in tablets, capsules, soft-gel capsules, as well as multiple functional food and beverage applications.

For more information, visit the new SoyLife website at soylife.com.

Released: 05/07/12

New Research Confirms Doctors Participating in Practice Improvement and Patient Management Programs Cost Less, Have Better Patient Outcomes

HCI3 analysis of claims finds programs like Pentient-Centered Medical Home and Bridges to Excellence most effective for patients with chronic conditions

Physicians participating in practice improvement and patient management programs such as the Patient-Centered Medical Home (PCMH) and Bridges to Excellence (BTE) realize better cost performance for patients with chronic conditions than their non-Recognized peers, according to recent research released today by the Health Care Incentives Improvement Institute, Inc. (HCI3).

The Patient-Centered Medical Home is an approach to providing comprehensive primary care and pilots are being supported by the Patient Centered Primary Care Collaborative. Managed by HCI3, a non-profit focused on improving health care quality and value through evidence-based incentive and payment solutions, BTE is a family of programs to reward Recognized physicians who meet certain performance measures. The results are available in the latest HCI3 Improving Incentives Issue Brief.

"Overall, these findings support emerging evidence on the use of practice-based systems that underlie the accreditation criteria for both programs," said Meredith B. Rosenthal, professor of Health Economics and Policy, Harvard School of Public Health. "In particular, studies are finding that improved population management focusing on chronic illness can impact inpatient utilization and/or emergency department visits."

PCMH-recognized physicians participating in pilots had a favorable cost performance amounting to approximately $12 per chronically ill member per month. BTE Diabetes-Recognized physicians had a favorable cost performance of approximately $36.50 per member with diabetes per month. The better performance was tightly associated to the management of certain patients for which quality measures were reported, and did not extend to other patients with chronic illness for whom quality metrics were not reported. These amounts, while not negligible, might be underestimating the full potential impact of PCMH practices on total plan member costs. However, the current findings also put into question the sometimes sizable per member per month payments made by private and public sector plans to PCMH-recognized practices.

"While PCMH and BTE-recognized physicians have a better cost performance than their non-recognized peers, that better performance seems to be limited to the chronic conditions for which they are actively reporting quality outcomes," said Francois de Brantes, HCI3 Executive Director.

The analysis found the current per member per month incentives paid for PCMH may be somewhat inflated. Health plans are paying on average between $15 to 20 per member per month, while the costs savings for a chronically ill patient is $12 or roughly $144 annually.

"The effect of good management on some patients with chronic conditions does not appear to spill over to other patients," de Brantes emphasized. "As such, employers as one of the largest purchasers of health care should (a) continue to pursue incentives for physicians to become recognized, (b) tie those incentives as much as possible to actual cost performance, and (c) tie all incentives to comprehensive quality scorecards that look at outcomes across patients with different chronic conditions, and not simply a slice of them."

Patients and Method
HCI3 performed an analysis of claims data using its PROMETHEUS Evidence-informed Case Rate (ECR) analytics software of commercially insured members from multiple health plans across the United States. The analysis included claims data that ranged from 2008-2010, covering 668,604 member lives, triggering 87,377 chronic episodes of care, and included 6,650 primary care physicians. Patients with one or more of six chronic conditions (Diabetes, Hypertension, Coronary Artery Disease, Chronic Obstructive Pulmonary Disorder, Asthma, and Gastro-esophageal Reflux Disease) were identified using the coding rules and clinical logic included in the software package.

About the Health Care Incentives Improvement Institute, Inc.
The Health Care Incentives Improvement Institute, Inc. (HCI3) is a non-profit multi-stakeholder umbrella organization for Bridges to Excellence and PROMETHEUS Payment. The mission of the organization is to create significant improvements in the quality and affordability of health care by developing and implementing programs that recognize and reward physicians, hospitals and other health care providers that deliver safe, timely, effective, efficient, equitable and patient-centered care. HCI3 offers a comprehensive package of solutions to employers, health plans and coalitions to improve the flawed incentives that currently permeate the US health care system. Visit HCI3.org for more information.

Released: 05/04/12

Karen Howard Takes Reins at National Animal Supplement Council

Karen Howard has been selected by the board of directors of the National Animal Supplement Council (NASC) to lead the organization as president into its next era. Bill Bookout, who has led the nonprofit industry trade association for the past 10 years, has accepted a newly formed position with Kemin Industries as vice president of global sales for the company’s Animal Nutrition and Health Vet division, however will remain actively involved and continue as chairman of the board with NASC.

Prior to her appointment with NASC, Howard served as executive director of the American Association of Naturopathic Physicians and was responsible for turning around the nonprofit’s $275,000 deficit into profitably managing a $1.6 million annual budget. She also successfully created a presence for naturopathic doctors on Capitol Hill earning them a respected position in the healthcare arena.

“Karen possesses the necessary leadership skills to run and manage a nonprofit effectively and is very experienced in federal and state legislative issues,” says Bookout, who will continue to spearhead federal and state regulatory actives for NASC. “But beyond her many talents, Karen has the level of passion required to take NASC to the next level. I know she will connect with our members and continue to accomplish great things for our organization and the animals.”

Howard started her career on Capitol Hill and has proven to work successfully with regulators to achieve positive outcomes for diverse groups of stakeholders. Many of her achievements are a result of working productively with Congress to implement legislation that positively impacts health and wellness industries.

“The animal health industry is positioned for continued growth and I see a huge opportunity for expanding consumer education through the NASC,” says Howard who has two rescue dogs, Razz and Scotty. “I admire the mission of NASC and the impact it will have on the health and wellbeing of companion animals worldwide.”

Since 2002, NASC has been the leader in educating consumers, veterinarians and business partners about credible animal supplement products and companies that have successfully completed facility audits of specific, nationally recognized standards through the Quality Seal Program. The NASC Quality Seal alerts consumers that they are buying from a reputable company that has successfully completed an independent quality audit. For a complete list of NASC member companies, visit animalsupplements.org.

Released: 05/04/12

Study Identifies Possible Protective Blood Factors Against Type 2 Diabetes

Researchers at Albert Einstein College of Medicine of Yeshiva University in collaboration with Nurses' Health Study investigators have shown that levels of certain related proteins found in blood are associated with a greatly reduced risk for developing type 2 diabetes up to a decade or more later. The findings, published today in the online edition of Diabetes, could open a new front in the war against diabetes.

These proteins are part of what is called the IGF axis. This axis was named for insulin-like growth factor-1, (IGF-1), so called because it has biological effects similar to those of insulin (the hormone that regulates blood glucose levels) but has a greater effect on cell growth than insulin. The researchers also looked at levels of several proteins known as IGF binding proteins, or IGFBPs, that may have strong effects independent of IGF-1.

Researchers have hypothesized that the IGF axis may influence risk for developing diabetes – an idea supported by laboratory and mouse studies, and a few initial studies in humans. However, the current study is the first large, prospective investigation of several components of the IGF-axis and the risk for developing diabetes, according to co-senior author Howard Strickler, MD, MPH, professor of epidemiology and population health at Einstein.

In the current study, the researchers analyzed levels of IGF-1, IGFBP-1, IGFBP-2, and IGFBP-3 in blood taken from 742 women in the Nurses' Health Study who years later developed type 2 diabetes as well as a similar number of women in the study who did not develop diabetes. None of the women had any signs or symptoms of the disease at the time their blood samples were taken. The median time between the taking of blood samples and diabetes onset was nine years.

Each component of the IGF axis (IGF-1 and IGFBP-1, -2, and -3) had a significant independent association with diabetes risk – most notably IGFBP-1 and -2. Compared with women in the bottom 20 percent with respect to their levels of IGFBP-1, having high levels of IGFBP-1 (top 20 percent) was associated with a three-fold reduction in risk for diabetes, while high levels of IGFBP-2 were associated with a more than five-fold reduction in diabetes risk.

"Our data provide important new evidence that circulating IGF-axis proteins may have a role in the development of type 2 diabetes," said Dr. Strickler.

The findings have potential clinical implications. First of all, IGF-axis proteins could help in stratifying people at risk for diabetes. "For example," said Dr. Strickler, "we know that obesity is a major risk factor for diabetes. But some overweight individuals don't develop diabetes, while some thin people do. If our findings are confirmed, they could help doctors more precisely determine who is actually at risk for the disease."

The proteins may also prove useful as targets for novel therapies to prevent or treat diabetes. But Dr. Strickler cautions that it's too early to apply these findings to clinical practice. "IGF-axis proteins have other effects, some beneficial and some not," he notes. "We need to learn more about the connection between the IGF-axis and diabetes before we recommend that people get tested for these substances, and before deciding how we can exploit the IGF-1 axis to help address diabetes."

The Diabetes paper is titled, "The Insulin-Like Growth Factor Axis and Risk of Type 2 Diabetes in Women." The first author was Swapnil Rajpathak (who was at Einstein at the time this work was conducted). The other senior author is Frank B. Hu, MD, PhD, of Harvard School of Public Health, Boston, MA. Additional contributors include Meian He, MD, PhD, (Harvard and Huazhong University of Science and Technology, Wuhan, Hubei, China); Qi Sun MD, ScD, (Harvard); Jeannette Beasley, PhD, RD, MPH, (Fred Hutchinson Cancer Research Center, Seattle, WA); Michael Pollak, MD, (McGill University, Montreal, Quebec, Canada); and Robert Kaplan, PhD, Radhika Muzumdar MD, MBBS, Thomas Rohan, MD, PhD, Mimi Kim, SciD, Jeffrey Pessin, PhD, and Judith Wylie-Rosett, EdD, all of Einstein. Co-author Marc Gunter, PhD, contributed to the paper while at Einstein.

The study was supported by grants from the National Institutes of Health. Laboratory testing and data analysis were supported in part by NIDDK 5-R01-DK-080792. The NHS is supported by grants CA-87969, DK-58845, and DK-58785 from the National Institute of Diabetes and Digestive and Kidney Diseases and the National Institute of Child Health and Human Development. Q.S. was supported by a career development award (K99HL098459) from the National Heart, Lung, and Blood Institute. The authors report no conflicts of interest.

Released: 05/02/12

Novel Joint Supplement Shown to Reduce Pain and Improve Overall Quality of Life for Osteoarthritis Sufferers

Osteoarthritis (OA) is the most common joint disorder in the US affecting more than 33 million Americans. This painful and disabling disorder is often considered a normal part of aging: the result of years of wear and tear on our bodies. Everyday activities, from sitting comfortably to brushing teeth, can become intolerable. While OA can’t be cured, promising new research shows that many people may find substantial relief from the most typical OA symptoms from a unique dietary supplement.

In results of a multi-center, double-blind, placebo-controlled human arthritis clinical study published by the prestigious Journal of Agriculture and Food Chemistry, researchers found that people suffering from joint conditions associated with OA experienced significant improvement in their pain levels, and ability to participate in everyday activities, after taking a healthy aging nutritional supplement called BioCell Collagen.

The supplement contains highly bioavailable forms of the major constituents of human joints: collagen type II, hyaluronic acid and chondroitin sulfate. There are more than 14 different types of collagen found in the body. Collagen type II is the main structural building block of soft connective tissue and joint cartilage. Previous studies have demonstrated that BioCell Collagen is well absorbed into the bloodstream, and indicate that its components are deposited into the joint cartilage.

“This ingredient has a lower molecular weight than other forms of joint supplements, which appears to be an important reason for its effectiveness,” comments Jerome Stenehjem, MD, School of Medicine, University of California at San Diego, a principle study investigator. “These study results are exciting, especially for people who want relief from their OA symptoms without experiencing the typical side effects associated with prescription drugs and over-the-counter pain relievers. It is possible that nutrients such as those found in this patented supplement may improve the qualit y of the joint fluid, thereby supporting better joint health.”

Clinical trial details
This recent study involved 80 patients, all of whom had painful and progressive OA in their hips or knee joints. They received either one gram twice daily of BioCell Collagen or a placebo for 70 days. Forty percent of the BioCell Collagen group experienced at least a 30 percent pain reduction compared to only three percent in the placebo group. Additionally, 51 percent of the BioCell Collagen group had at least 40 percent reduction in assessment scores measuring pain, stiffness and overall physical difficulties while only 12 percent of those in the placebo group found that level of relief. Side effects were minimal, and comparable in both groups.

“This was the largest randomized controlled human study to date of BioCell Collagen, and it confirms previous studies that demonstrated similar effectiveness and safety,” stated Stenehjem.

Added study investigator Alexander G. Schauss, PhD, FACN, Senior Director of AIBMR Life Sciences, “This was a well-designed study published by one of the most recognized scientific journals in the world. We are pleased that results build on the substantial body of evidence indicating BioCell Collagen’s potential to make a difference in people’s lives.”

BioCell Collagen

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