Past News Items - April 2012

A nationwide study led by Dr. Jed Nuchtern, chief of the division of pediatric surgery at Texas Children's Hospital, a pediatric surgeon with Texas Children's Cancer Center and professor of surgery at Baylor College of Medicine, found that the majority of infants with a particular form of neuroblastoma—a childhood tumor that often requires intensive chemotherapy and surgery—excel in their overall progress and survival when the tumor is monitored without surgical resection.

The results of the study will be presented at the American Surgical Association's 132nd annual meeting being held in San Francisco from April 26 to 28.

In this 10-year study, surgeons and oncologists who identified babies less than 6 months of age with a small tumor suggestive of neuroblastoma were given the option of immediate surgery or monitoring the baby carefully via ultrasound and urine tests. Overall, 87 babies who had tumors found either prenatally or before 6 months of age were entered into the study.

Of 87 babies, only four underwent surgery immediately—all of whom did well—while 83 were followed carefully for at least 15 months. Of the group that was followed, 16 children had surgery due to changes on one of the screening studies with eight found to have stage one neuroblastoma and only two with higher stages. There were no tumors that required additional intensive chemotherapy.

Most importantly, the three-year overall survival for the 83 babies who were followed by observation was 100 percent with median follow-up now of three years. Overall, 81 percent of these young babies on the observation arm were spared the need for surgery. The results of this study reveal that it is safe to carefully observe babies—specifically infants less than 6 months of age—who have a special, small isolated neuroblastoma tumor.

The investigators are now planning a study that will expand to include patients who are 1 years old at diagnosis and who have larger neuroblastoma tumors. The study was sponsored by the Children's Oncology Group and included participation by more than 100 physicians from more than 75 pediatric programs across the United States and Canada, including Texas Children's Cancer Center.

For more information about the Texas Children’s Hospital, please visit texaschildrens.org.

Released: 04/27/12

Rock Creek Pharmaceuticals Announces First Study Using Anatabloc Nutritional Supplementation in Alzheimer's Patients

Star Scientific, Inc. through its wholly owned subsidiary, Rock Creek Pharmaceuticals, Inc., announces that it has received IRB approval of the first human clinical study of the safety and effects of nutritional supplementation with Anatabloc in individuals with Alzheimer's disease. The study will be undertaken in conjunction with the Roskamp Institute of Sarasota, Florida, which has been acting as a research partner in assessing the impact of Anatabloc on Alzheimer's.

This study developed out of Roskamp's earlier research work published in the European Journal of Pharmacology (Paris D et al. Anatabine lowers Alzheimer's AB production in vitro and in vivo, Eur J Pharmacol. 2011 Nov 30;670(2-3):384-91) and multiple reports of use of the supplement in users with Alzheimer's disease. Both Rock Creek's and Roskamp's medical teams agreed that enough preliminary data was now available to initiate the study.

The study, entitled "A Three Month, Single-Site or Multi-Site, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Trial to Evaluate the Safety, Tolerability and Potential Effects of the Dietary Supplement Anatabine in Subjects with Alzheimer's Disease" is a six-visit, double-blind, randomized, placebo-controlled, parallel-group trial to evaluate the safety, tolerability, and potential effects of anatabine dietary supplementation in subjects with mild to moderate Alzheimer's disease (AD).

Secondary aims are to evaluate the effects of this specially formulated version of Anatabloc (patent pending) on amyloid beta (AB), global outcome, and functional measures of AD. Although the Roskamp Institute will be the primary study site, it is anticipated other sites may be added as needed to fulfill enrollment goals. The study will enroll subjects at least 65 years of age with a diagnosis of mild to moderate Alzheimer's disease, and it is expected that a minimum of 120 subjects will complete the trial.

Dr. Ryan Lanier, Chief Clinical Scientist for Rock Creek Pharmaceuticals, who coordinated the development of the study protocol, commented, "The Roskamp Institute has done its usual thorough job in working with Rock Creek to design a study that will begin to bring definitive answers to whether supplements of this class are tolerable and have demonstrable effects in supporting the medical treatment of individuals with this terrible condition. In answering calls from physicians looking for ways to support their patients suffering from Alzheimer's, it has been intensely frustrating to tell them that we are preparing for such a study, but have to complete the preliminary work to support a study in this population. Doing good science takes time and patience, but I am very glad we have the data needed to get started. The work done by Roskamp to date has been of world-class quality and I am confident that the same quality will continue in its role as the primary site for the Alzheimer's study. We will do everything we can to support the Roskamp Institute in that effort."

Rock Creek Pharmaceuticals and the Roskamp Institute have worked collaboratively on research relating to the company's anatabine compound for a number of years, occasioned by the Institute's interest in the effect of the compound on immune system support. Inflammation and the proper or aberrant functioning of the immune system is a critical factor in a number of neurological disorders studied by the Institute, and helping the immune system regain its natural balance through nutrition is one path toward supporting current medical treatments for such conditions.

Paul L. Perito, Rock Creek's Chairman and CEO stated, "I have waited a long time for this pivotal event, with considerable anticipation. We strongly believe that our nutritional products will be of value to physicians in providing optimal care for their patients, and I'm going to make sure that we do everything we can to get this study done as fast as possible."

Released: 04/27/12

miRagen Therapeutics Announces the Publication of Compelling Data Suggesting the MIRG-9103 Program May Have Utility in Treating Multiple Disorders Associated with Metabolic Syndrome

MiRagen Therapeutics, Inc., a biopharmaceutical company developing innovative microRNA (miRNA)-based therapeutics primarily for the treatment of patients who suffer from cardiovascular and muscle disease, announced today that scientific results published in the journal Cell reveal the central role of the heart in whole-body metabolism.

The data suggests that miRagen’s lead program, MIRG-9103 (antimiR-208), in addition to providing benefit in the setting of cardiac dysfunction, may have therapeutic utility in a variety of metabolic disorders that contribute to Metabolic Syndrome. Metabolic Syndrome is a cluster of conditions—increased blood pressure, a high blood sugar level, excess body fat around the waist, and abnormal blood lipid and cholesterol levels—that occur together, increasing the risk of heart disease, stroke, and diabetes. The MIRG-9103 program is one subject of the cardiovascular drug development alliance between miRagen Therapeutics and Servier. The research was conducted by miRagen scientists in collaboration with researchers at The University of Texas Southwestern Medical Center.

“These findings build on what we already know about the important role for the cardiac specific microRNA-208 in heart disease,” said Eric N. Olson, PhD, Chief Scientific Advisor and Co-Founder of miRagen Therapeutics, Inc. Dr. Olson is the study's senior author and Chairman of Molecular Biology at UT Southwestern. “The fact that pharmacological treatment with antimiR-208 in a model of diabetes and obesity shows profound beneficial effects in regulating systemic energy homeostasis changes the way we view the role of the heart in metabolism. The implications for therapeutic intervention in these areas are significant.”

In addition to revealing whole-body metabolism regulation by the heart, the data has significant implications for the potential of miRagen’s lead compound to treat a variety of cardiometabolic disorders. More specifically, the paper clearly indicates that modulating the miR-208 gene control pathway enhances metabolic rate, improves insulin sensitivity and glucose handling, lowers blood triglyceride and cholesterol levels, reduces fat deposition in adipose and liver, and confers resistance to obesity. These attributes suggest a potentially central role for miR-208 directed therapies in treating the conditions that contribute to Metabolic Syndrome.

“Metabolic Syndrome is unfortunately becoming increasingly common in the United States and the developing world,” said William S. Marshall, Ph.D., President and Chief Executive Officer. “We have previously published compelling results in model systems demonstrating the beneficial effects of antimiR-208 dosing in prevention of heart failure. The results reported today show that we may also be able to address many metabolic conditions that contribute to the development of cardiovascular disease. We are hopeful that these unprecedented results can further our goal of bringing life-changing medicines to patients in need.”

About microRNAs: MicroRNAs have emerged as an important class of small RNAs encoded in the genome. They act to control the expression of sets of genes and entire pathways and are thus thought of as master regulators of gene expression. Recent studies have demonstrated that microRNAs are associated with many disease processes. Because they are single molecular entities that dictate the expression of fundamental regulatory pathways, microRNAs represent potential drug targets for controlling many biologic and disease processes.

About miRagen Therapeutics: MiRagen Therapeutics, Inc., is a biopharmaceutical company founded to harness the power of microRNA (miRNA) biology and develop innovative microRNA-based therapeutics for cardiovascular and muscle disease. In October 2011, miRagen and Les Laboratoires Servier, a leading European pharmaceutical company, entered into a strategic alliance for the research and development of microRNA-based therapeutics for the treatment of patients afflicted with cardiovascular disease. Combining in-house expertise in microRNA biology and chemistry with strong external partnerships and academic collaborations, miRagen is striving to make a difference in health care across the globe. For more information, please visit miragenrx.com.

Released: 04/25/12

Soy-Based S-equol Supplement Reduces Hot Flash Frequency, Muscle and Joint Pain in US Postmenopausal Women

A dose of 10 milligrams (mg) daily of S-equol delivered via a newly developed fermented soy germ-based nutritional supplement is as effective as a standard dose of soy isoflavones at reducing hot flash frequency significantly and is even more effective for relieving muscle and joint pain, according to a peer-reviewed study in US postmenopausal women published in the June Journal of Women's Health, available now as a Fast Track article online ahead of print.

"This study provides evidence that daily doses of the supplement S-equol, a metabolite of the soy isoflavone daidzein, reduced hot flash frequency and relieved muscle and joint pain in US postmenopausal women. These findings confirm earlier studies in Japanese women documenting S-equol's ability to relieve menopausal symptoms," said Belinda H. Jenks, PhD, coauthor of the study and director of Scientific Affairs & Nutrition Education at Pharmavite LLC. Development and ongoing research of a supplement containing S-equol is conducted by the Saga Nutraceuticals Research Institute of Otsuka Pharmaceutical Co., Ltd. Pharmavite LLC, the makers of Nature Made vitamins and minerals, is a subsidiary of Otsuka, which supported the study.

S-equol Supplement Reduces Menopausal Hot Flashes, Muscle and Joint Pain in US Women
Daily doses of the supplement containing 10, 20 or 40 mg of S-equol each reduced the frequency of moderate to severe hot flashes similarly to a 50 mg dose of a soy isoflavone supplement in a double-blinded randomized study involving 102 US postmenopausal women aged 45 to 65 who experienced more than 35 hot flashes weekly when they enrolled. The investigators used a standardized soy isoflavone supplement for comparison in the study because of the scientific consensus that extracts or concentrated soy isoflavones support relief of hot flashes in menopausal women, based on placebo-controlled studies.

The investigators observed, after eight weeks of treatment, significant reductions occurred from the study start in the women's average daily hot flashes, the study's primary endpoint. These reductions were comparable for all three S-equol treatment groups, 10, 20 or 40 mg, which ranged from decreases of 3.09 to 3.66 hot flashes daily, to that of the soy isoflavone group, which averaged decreases of 2.92. The average number of daily hot flashes in all of the participants at the study start was 10.0 +/- 4.03.

Muscle and joint pain improved significantly for both the 10 and 20 mg doses of S-equol compared with the soy isoflavones (p=0.003 and p=0.005, respectively), based on scores from the Greene Climacteric Scale (GCS), which measures 21 symptoms using 0 to 3 scale, where 0 was 'not at all,' 1 was 'a little,' 2 was 'quite a bit' and 3 was 'extremely,' to produce scores.

"These US data expand on the previous studies in Japanese women and further document that a minimum daily 10 mg dose of S-equol would likely help women by both reducing the frequency of their hot flashes as well as decreasing their muscle and joint pain associated with menopause," said Jenks.

Further, for women who had more than eight hot flashes daily at the study start, both 20 and 40 mg S-equol were significantly better than the soy isoflavones in reducing hot flash frequency (p=0.045 and p=0.001, respectively), while the 10 mg S-equol dose had a strong positive trend (p=0.063), according to a sub-group analysis. This finding suggests that the S-equol supplement might be more useful for the women who have a higher frequency of hot flashes, Jenks said.

Also, more women in the 10, 20 and 40 mg S-equol groups achieved a reduction of 50 percent or more in their hot flash frequency by the study end than in the soy isoflavone group: respectively, 25.0, 27.3, 42.9 (P=0.056) and 16.0 percent.

No trends or clinically meaningful changes were identified in the women's laboratory blood or urine tests, hormone levels, electrocardiographs, physical examinations or vital signs. The trial investigators noted treatment-emergent adverse effects in participants of all the treatment groups. Such effects occurring in more than 10 percent of any S-equol group included abdominal distention (eight women) and endometrial hypertrophy (three women), the thickening of the lining of the uterus. The endometrial hypertrophy was identified by transvaginal ultrasounds and was assessed by the Medical Monitor; any changes observed were not considered to be clinically significant.

Of note, Jenks explained, endometrial hypertrophy developed in three women in the 10 mg S-equol group but only one and none in the 20 mg and 40 mg S-equol groups, respectively, which suggest that S-equol does not affect endometrial hypertrophy. Moreover, gastrointestinal disorders in the seven women in both 10 mg and 20 mg S-equol groups as well as the one in the 40 mg S-equol and two in the isoflavone groups, may have resulted from the naturally occurring dietary fiber in the fermented soy germ-based nutritional supplement containing S-equol and from the lactose in the placebo tablets used to match the total number of tablets in each group.

At enrollment, the women had not experienced a menstrual period in the previous 12 months and their levels of follicle stimulating hormone (FSH) were 40 or more milli international units/milliliter, a marker of menopause. The women were in good health. Investigators did not enroll anyone with a history of breast, ovarian or uterine cancer or endometrial hyperplasia, with a body mass index of 33 kilograms per meters squared or more or who had used hormone replacement therapy within 90 days of the study or soy, phytoestrogens or certain other supplements within 30 days of the study, as well as fitting certain other exclusion criteria.

Investigators randomized the 102 women into four groups to consume twice daily either the isoflavone (26 women) or one of the three doses of the S-equol supplement (24 in the 10 mg, 27 in the 20 mg and 25 in the 40 mg groups). The lowest dose of S-equol used, 10 mg, was based on preliminary studies that investigated the relationship between S-equol and menopausal symptoms including hot flashes in Japanese women, while the higher doses were used to reflect the larger body mass in Western women and to establish a dose response. The S-equol supplement tablets each contained 5.0 mg S-equol, 1.0 mg daidzein, 1.1 mg genistein, and 2.5 mg glycitein. The soy isoflavone tablets contained 24 mg daidzein, 22 mg genistein, and 2.0 mg glycitein as aglycone equivalent. The placebo tablets contained lactose.

The women had diets controlled for soy foods, isoflavones and lignans, compounds found in certain plants that are known as phytoestrogens because of their estrogen-like properties. The study included a seven-day period before the treatment weeks to allow for elimination of any women who responded to a placebo. Women also were tested to determine their ability to produce S-equol after eating soy. The study included 72 percent equol nonproducers and 28 percent equol producers, which represents the previously reported US equol producer ratio. The investigators randomized the equol producers equally into each of the study's treatment groups.

No previous studies have reported the effects of either soy isoflavones or S-equol on muscle and joint pain. Recent studies conducted with Japanese postmenopausal women documented that measures of neck or shoulder muscle stiffness improved with daily consumption of 10 mg S-equol supplements, compared to a placebo, as well as reduced the frequency of hot flashes. While muscle stiffness and muscle pain can result from impaired local blood flow and both soy isoflavones and S-equol are thought to affect blood flow, this new study suggests that S-equol may potentially be more effective than isoflavones, Jenks explained.

Journal of Women's Health, Online Ahead of Print: March 12, 2012 doi:10.1089

For more information about Otsuka Pharmaceutical Co., Ltd, visit otsuka.co.jp/en.

Released: 04/23/12

Parkinson's Disease Foundation Offers Free Online Course to Physical Therapists to Improve Lives of People with Parkinson's

The Parkinson's Disease Foundation (PDF) is pleased to offer physical therapists a free online course, "Parkinson's Disease: A Practical Approach to Evaluation and Treatment for the Physical Therapist," which is being taped in front a live audience today in New York, NY. The course is designed by expert physical therapists in the field of Parkinson's to help other physical therapists provide better care for the nearly one million people in the United States (US) living with Parkinson's.

During the month of April, which is Parkinson's Awareness Month, 5,000 people in the US will be newly diagnosed with Parkinson's. While no treatment can prevent or reverse Parkinson's, research suggests that physical therapy can improve physical mobility and quality of life. For example, people with Parkinson's often experience difficulty walking, rising from chairs and moving in bed. Research has shown that physical therapy can help improve strength, fitness level, walking speed and balance, leading to reduced disability and greater independence, says planning committee member Terry Ellis, PT, PhD, NCS.

Physical therapists and people with Parkinson's alike have communicated the need for trained physical therapists to care for the growing Parkinson's community. To meet this need, PDF is collaborating with the American Parkinson Disease Association (APDA), the American Physical Therapy Association (APTA) and the Visiting Nurse Service of New York (VNSNY), to bring the latest evidence-based information to physical therapists. The course includes ten educational sessions and two interactive panel discussions.

Dr. Ellis, also a Clinical Associate Professor at Boston University's College of Health and Rehabilitation Sciences: Sargent College, in Boston, MA, said, "As physical therapists, we can make a difference in the lives of people with Parkinson's—helping individuals to navigate the movement challenges that affect activities of daily life through engagement in exercise over the course of the disease. This course puts the latest evidence-based findings in the hands of practitioners around the country to help them provide the best care possible."

Robin Anthony Elliott, Executive Director of PDF, noted, "Physical therapists play a critical role in helping people with Parkinson's to manage their disease day-to-day. PDF is committed to providing physical therapists and other health care professionals with the tools they need—whether through this online course or via other educational programs—to improve the lives and futures of people touched by Parkinson's."

As of Friday, May 4, the course will be available free on PDF's website at http://support.pdf.org/ptherapy. Physical therapists can view the course over the next year at their convenience. 0.8 continuing education units are available.

Released: 04/18/12

A New Guide to Using Acupuncture for Sleep Disorders

Thieme Medical Publishers is proud to announce the publication of Acupuncture for Insomnia: Sleep and Dreams in Chinese Medicine, a text that presents a highly effective treatment for chronic and acute sleeplessness using therapeutic strategies from both TCM as well as Classical Chinese Medicine. This text provides a complete background on the physiology, causes, and treatment of sleep disorders, drawing parallels between concepts of Western and Chinese Medicine, and it classifies all acupuncture points that affect sleep to help in choosing the most appropriate treatment.

“Hamid Montakab, MD, the inspired author of this book, has taken on the vision and task beyond the current literature available on sleep, insomnia, and dreams. Sharing his vision not only from his understanding of the research from Western medicine, but also weaving the wisdom of Chinese medicine and the influence of French acupuncture, Dr. Montakab has created a comprehensive approach for delving into the mystery of sleep. Beyond the alpha waves, hormones, circadian rhythms, and wandering hun, Dr. Montakab investigates the significance of sleep to the essence of our spirit. With the integration of these various traditions, the content of this book will provoke the clinician, comfort the patient, and implore the reader to utilize these protocols.” – From the Foreword by Jeffrey C. Yuen, Daoist Traditions (College of Chinese Medical Arts)

Written from the unique perspective of a physician who is also trained in TCM and classical acupuncture, the book presents numerous case examples, and an up-to-date review of scientific studies on Chinese medicine and sleep. It is an essential reference for all acupuncture practitioners who provide optimal treatment to patients with insomnia, sleep disorders, and other sleep pathologies.

For more information about Theime Publishing Group, visit theime.com.

Released: 04/16/12

Nutraceutical Ingredients Market is Expected to Reach USD 29.5 Billion Globally in 2017: Transparency Market Research

According to a new market report published by Transparency Market Research, "Nutraceutical Ingredients Market—Global Industry Analysis, Market Size, Share, Growth And Forecast 2007 – 2017," the global nutraceutical ingredients market is expected to be worth USD 20.8 billion in 2012 and is further expected to reach USD 29.5 billion in 2017, growing at a CAGR of 7.3 percent from 2012 to 2017.

The body building segment is expected to be the largest segment at USD 9.5 billion in 2012. In the overall global market, Asia Pacific region is expected to maintain its lead position in terms of revenue till 2017. Asia Pacific is expected to enjoy 37.5 percent of global nutraceutical ingredients market revenue share in 2017 followed by North America.

Increasing number of clinical studies confirming the health benefits of nutraceuticals and their broad applications in food, beverages, dietary supplements, and pediatric and adult nutritional preparations has provided support for the growing use of nutraceutical ingredients. Moreover, faster growth in consumption of nutraceutical ingredients worldwide, especially in developing economies has boosted the growth of nutraceutical ingredient market. In addition, increasing economic prosperity in developing countries including India, China, Brazil, Mexico, Russia, South Africa, South Korea, and Poland will enable consumers to spend more on health and nutrition. This will boost the future growth of the nutraceutical ingredient market.

Major segments of nutraceutical ingredients market include body building, weight control, diabetes control and pain relief. In 2011, body building was the largest segment followed by weight control. The controlling diabetes segment was the third largest segment, accounting for 16.5 percent revenue share in 2011.

Amino acids and soy-based ingredients segments of body building market witnessed healthy growth rate during the review period (from 2007 to 2011). The growth in amino acid and soy-based ingredient segment is largely attributed to increased trend of fitness in most of the developing nations. The protein and peptide segment is also expected to have steady growth rate because of growing demand for nutritional diet and proper physic all over the world.

Nutraceutical ingredients presents opportunity for new entrants as well for existing players, due to the fact that most of the raw materials are abundant and product manufacturers are increasingly focusing on contract manufacturing outsourcing (CMO). Moreover, large product manufacturers are looking for backward integration, which will grow the competition into the market and will intern increase the market size of the nutraceutical ingredients.

This report is an effort to identify factors, which will be the driving force behind the nutraceutical ingredient market and its sub-markets over the next six years. The report provides extensive analysis of the nutraceutical industry, current market trends for better understanding of the nutraceutical ingredient market. The study presents a comprehensive assessment of the global nutraceutical ingredient market on the basis of:

Body Building

Probiotics and Prebiotics
Proteins
Peptides
Amino acids
Soy-based ingredients
Omega 3

Weight Control

Fibers and carbohydrates
Minerals
Vitamins & premixes

Controlling Diabetes

Antioxidants & Carotenoids
Dairy-based Ingredients

Pain Relief

Nutritional lipids and oils
Phytochemicals & Plant extracts

To browse the report, click here.

Released: 04/16/12

New Method May Help Detect Marker for Alzheimer’s Disease Earlier

Use of a new drug to detect the beta-amyloid plaques in the brain that are hallmark signs of Alzheimer's disease may help doctors diagnose the disease earlier, according to research that will be presented as part of the Emerging Science program (formerly known as Late-Breaking Science) at the American Academy of Neurology's 64th Annual Meeting in New Orleans April 21 to April 28, 2012.

Currently, Alzheimer's disease can only be definitively confirmed through the detection of amyloid plaques and/or tangles in the brain during autopsy after death or with a brain tissue biopsy. The new method uses the drug florbetaben as a tracer during a PET scan of the brain to visualize amyloid plaques during life.

In order to prove that the florbetaben PET scan detects beta-amyloid in the brain, the global phase III study directly compared brain regions in the PET scan to respective brain regions after death during autopsy.

For the study, more than 200 participants nearing death (including both participants with suspected Alzheimer's disease and those without known dementia) and who were willing to donate their brain underwent MRI and florbetaben PET scan. The amount of plaque found in the 31 participants who reached autopsy was then compared to the results of the scans. A total of 186 brain regions from these donors were analyzed along with 60 brain regions from healthy volunteers. Based on these 246 brain regions the study found florbetaben to detect beta-amyloid with a sensitivity of 77 percent and a specificity of 94 percent.

Comparison of the visual assessment method proposed for florbetaben for clinical practice with the post mortem diagnosis revealed a sensitivity of 100 percent and a specificity of 92 percent. Sensitivity is the percentage of actual positives that are correctly identified as positive, and specificity is the percentage of negatives that are correctly identified.

"These results confirm that florbetaben is able to detect beta-amyloid plaques in the brain during life with great accuracy and is a suitable biomarker," said study author Marwan Sabbagh, MD, director of Banner Sun Health Research Institute in Sun City, Arizona, and a Fellow of the American Academy of Neurology. "This is an easy, non-invasive way to assist an Alzheimer's diagnosis at an early stage. Also exciting is the possibility of using florbetaben as tool in future therapeutic clinical research studies where therapy goals focus on reducing levels of beta-amyloid in the brain."

The study was supported by Bayer Healthcare Berlin.

Learn more about Alzheimer's disease at http://www.aan.com/patients.

Released: 04/12/12

Cleveland HeartLab Launches "it" Campaign to Raise Awareness of Inflammation Testing

Cleveland HeartLab Inc. (CHL), a rapidly growing specialty clinical laboratory and cardiovascular disease management company, today announced the launch of a campaign to educate patients and health care professionals about the importance of "it," or inflammation testing, in determining heart attack and stroke risk. A unique inflammation biomarker panel is at the heart of CHL's advanced approach to cardiovascular disease risk assessment.

Cardiovascular disease continues to be the leading killer in the United States. But approximately 50 percent of patients who have a heart attack or stroke have normal levels of cholesterol. Research has demonstrated that the degree of inflammation in one's arteries is a better predictor of heart attack and stroke than cholesterol testing alone. CHL's inflammation panel offers broader prognostic coverage than traditional blood tests and enables a determination of the degree to which someone is at risk for a cardiovascular event.

"Our new 'it' campaign is designed to engage patients about the benefits of inflammation testing and its role in advanced cardiovascular risk assessment like they've never been before," said Marc S. Penn, MD, PhD, FACC, chief medical officer of Cleveland HeartLab and director of research, Summa Cardiovascular Institute, Akron, Ohio. "The campaign will generate increased understanding of inflammation testing and the significant role it plays in the assessment of cardiovascular disease and improved patient outcomes."

CHL's campaign employs a variety of tools that play on the abbreviation of "inflammation testing" to the word "it." The campaign provides a simple, easy-to-understand approach to inflammation testing awareness and education that engages both patients who may be at risk for heart disease and practitioners. The company's approach includes print and web ads (what is it?), waiting room brochures (how important is it?), patient reminder cards (make sure you get it) and other educational materials. These materials spark patient questions and direct them to easy-to-understand information about inflammation testing and how it can dramatically improve assessment of their cardiovascular health.

"Cleveland HeartLab's approach to inflammation is essential in the identification and prevention of heart disease," said Dharmesh S. Patel, MD, FACC, a cardiologist and diplomate in clinical lipidology at Stern Cardiovascular Foundation, Memphis, Tenn. "CHL's new 'it' campaign is a great step forward in assisting practitioners with educating patients about inflammation testing. Some cardiovascular disease risk factors are well known, but the role of arterial inflammation, a strong predictor of risk, is not always as well understood. CHL's inflammation-related biomarkers allow us to better define patients at risk for cardiovascular events and to determine where they are on the risk spectrum. Cleveland HeartLab's campaign is important because it elevates the additive power of inflammation testing in advanced cardiovascular disease risk assessment."

"Our advanced approach to cardiovascular disease risk assessment has been gaining tremendous momentum with thousands of health care professionals," said Jake Orville, president and chief executive of CHL. "CHL's simple, but powerful campaign will accelerate that momentum by providing clear information to patients about the importance of inflammation testing. We are especially pleased to be able to kick off our campaign as our panel of inflammation biomarkers takes center stage at this year's TEDMED conference."

The annual TEDMED conference, being held April 10 to 13, explores the issues, challenges and innovations that are shaping the future of health and medicine. At this year's conference, participants may choose to receive inflammation testing that uses CHL's proprietary biomarkers and the company's advanced approach to inflammation.

For more information about Cleveland HeartLab, visit clevelandheartlab.com.

Released: 04/11/12

Stem Cell Injections in Lou Gehrig's Disease can be Given Safely, New Research Shows

U-M ALS expert leads trial at Emory University

The first published results from an early-stage clinical trial show that spinal cord stem cells can be delivered safely into the spines of patients with the condition commonly known as Lou Gehrig's disease, opening the door for further research on this innovative approach.

In a paper published online ahead of print publication in the peer-reviewed journal Stem Cells, a team from the University of Michigan, Emory University and study sponsor NeuralStem, Inc. report the results from 12 patients who took part in a study being conducted at Emory.

All had amyotrophic lateral sclerosis, the inevitably fatal degenerative disease of the nervous system that many call Lou Gehrig's disease. None experienced any long-term complications related to either the surgical procedure or the implantation of stem cells, or showed signs of rejecting the cells. And in the months following the surgery to inject the cells, none showed evidence that their ALS progression was accelerating.

U-M Medical School ALS Eva Feldman, MD, PhD, is the principal investigator for the trial, and serves as a consultant to NeuralStem as part of her university role. She is also the director of the A. Alfred Taubman Medical Research Institute and the U-M Health System's ALS Clinic.

"This important publication reinforces our belief that we have demonstrated a safe, reproducible and robust route of administration into the spine for these spinal cord neural stem cells," says Feldman, who is senior author of the new paper and the Russel N. DeJong Professor of neurology. "The publication covers data up to 18 months out from the original surgery. However, we must be cautious in interpreting this data, as this trial was neither designed nor statistically powered to study efficacy."

The trial, which is taking place at Emory University, began in January 2010. The first 12 patients received neural stem cell transplants in the lumbar, or lower, region of the spinal cord. After reviewing safety data from these patients, the FDA has granted approval for the trial to advance to the final two groups of patients (three in each group), all of who will be transplanted in the cervical, or upper, region of the spinal cord.

Nicholas Boulis, MD, associate professor of neurosurgery at Emory School of Medicine, performs the surgery to implant the cells. He also developed the device used to inject the stem cells into the spinal cord, which received a notice of patent allowance from U.S. Patent and Trademark Office in October. NeuralStem has purchased an exclusive license to this technology.

Boulis trained in neurosurgery at U-M, and collaborated on research with Feldman during his seven years of residency. He holds an adjunct associate professor of neurology position at U-M and is one of the Taubman Scholars at the U-M Taubman Institute.

Also known as Lou Gehrig's disease, ALS is a fatal neurodegenerative disease with no known cure. It causes the deterioration of specific nerve cells in the brain and spinal cord called motor neurons, which control muscle movement. As the illness progresses, patients lose their ability to walk, talk and breathe. According to the ALS Association, approximately 30,000 Americans have ALS at any given time and patients with the disease usually die within two to five years of diagnosis.

This is the first US clinical trial of stem cell injections into the spinal cord for the treatment of ALS. The study is funded by the Maryland-based biotech company NeuralStem, Inc., which is also providing the human neural stem cells for transplantation. NeuralStem's cells have the ability to mature into various types of cells in the nervous system, including the motor neurons that are specifically lost in ALS. However, scientists say the goal of stem cell transplantation is not to generate new motor neurons, but to protect the still-functioning motor neurons by nurturing them with the stem cells, potentially slowing the progression of the disease.

For more about the ALS Center and clinical trial at Emory, visit http://neurology.emory.edu/ALS/index.html.

For more about the ALS Clinic at Michigan, visit http://www.uofmhealth.org/medical-services/als+lou+gehrigs+disease.

Citation: Stem Cells an 'Accepted Article', doi: 10.1002/stem.1079

Released: 04/11/12

Novel Atherosclerosis-Reversing, Heart Disease Therapy Wins NIH Clinical Development Grant

KineMed's "Reverse Cholesterol Transport" FX-5A apoA-I high-density lipoprotein mimetic peptide is awarded a Rapid Access to Intervention Development (RAID) grant by the National Institute of Health

KineMed Inc. today announced its successful award of a Rapid Access to Intervention Development (RAID) peer-reviewed grant by the National Institute of Health to advance an HDL mimetic, designated FX-5A, designed to reverse atherosclerosis and heart disease.

Reverse cholesterol transport is the body's natural process for removing unwanted cholesterol from sites of excessive deposition, including atherosclerotic plaques in arterial walls. Reversing atherosclerosis, the deposit of plaques containing cholesterol and lipoid material in arteries, by increasing the number of high-density lipoprotein, "HDL", particles and increasing reverse cholesterol transport, represents a new therapeutic paradigm. Current low-density lipoprotein, "LDL" cholesterol, lowering therapies are effective to reduce the risk of coronary events by only 30-percent, whereas studies suggest that for any given level of LDL-cholesterol, cardiovascular risk may be further reduced by an increase in HDL particle levels.

"We are honored to acknowledge this substantial award from the NIH BrIDGs program for assistance with manufacturing, formulation and IND enabling safety studies, to advance our novel ApoA-I mimetic lead compound for the treatment of atherosclerosis and cardiovascular diseases," said Dr. Scott Turner, Executive Vice-President, R&D at KineMed. "Raising HDL particle levels with the goal of increasing reverse cholesterol transport is a prime objective of our approach for further reduction of coronary events in patients at risk. While there are many current therapies in development looking to mimic human HDL, FX-5A has strong potential as a game-changing therapeutic because it is a small synthetic peptide optimized to efflux cholesterol, whereas the majority of other strategies focus on biologics."

"We thank the NIH and are proud to be collaborating on progress towards a life-saving therapy that can potentially bring benefit to millions of Americans threatened by cardiovascular disease. This award highlights KineMed's powerful insights into cholesterol biology and our ability to more rapidly and cost-efficiently advance therapeutics," said David Fineman, CEO & President of KineMed. "That we are able to see the mechanism of action—in action—is key. Through quantitative assays that we have developed and validated in association with thought leaders in this field, we can not only measure cholesterol efflux, but also account for the pluripotency of drug effects, by seeing both on- and off-target effects. These same techniques enable us to subtype the relevant patient populations that can be effectively treated, towards the broader goals of personalized medicine to streamline societal healthcare costs to large populations."

About HDL Therapy

Intravenous administration of apolipoprotein (apo) A-I complexed with phospholipid has been shown to rapidly reduce plaque size in both animal models and humans. Short synthetic amphipathic peptides can mimic the antiatherogenic properties of apoA-I and have been proposed as alternative therapeutic agents. High-density lipoprotein (HDL) levels have consistently been shown to be inversely related to cardiovascular disease risk. HDL promotes the flux of excess cholesterol from peripheral cells to the liver by the reverse cholesterol transport (RCT) pathway. Based on the inverse relationship between HDL and the incidence of cardiovascular disease, there has been great interest in developing drugs that raise HDL. Except for niacin there has been limited success in finding small-molecule drugs that increase HDL and decrease cardiovascular disease. This has prompted the development of a new treatment strategy called HDL therapy, which involves the intravenous infusion of exogenous HDL to rapidly stabilize patients with acute coronary syndrome. Even a single infusion of HDL has been shown in animal studies to reduce plaque size, lipid content, and inflammation. In human clinical trials, benefit in reducing atherosclerotic plaques has been observed after only 4-5 treatments with HDL therapy, and hence it has been proposed as a way to rapidly stabilize acute coronary syndrome patients.

Statin drugs are currently the predominant class of drugs prescribed to reduce the synthesis of LDL-cholesterol in the body. As a complement to statins, HDL therapy can move a large amount of cholesterol out of the body, up to 10g per day—about the size of a pat of butter.

For more information about KineMed, visit kinemed.com.

Released: 04/10/12

Recurrent Prostate Cancer Treatment: Research Indicates New PHC Dietary Supplement May Help

Preliminary findings from an FDA-approved clinical trial indicate that the experimental dietary supplement Prostate Health Cocktail (PHC) may arrest and in some cases lower rising PSA (Prostate Specific Antigen) in men with recurrent prostate cancer. Principal investigator Tanya Dorff, MD, reported this early research data at a February meeting of the American Society of Clinical Oncology.

PHC was associated with PSA stabilization in more than four out of every five research participants and a PSA decline in nearly one out of every three subjects. Conducted at the University of Southern California's Norris Comprehensive Cancer Center in Los Angeles, the study remains ongoing.

"The purpose of the study is to test whether the ingredients in PHC can induce PSA declines," explains Dr. Dorff. Thus far, 28 men ages 58 to 64 have participated and been treated with three PHC capsules daily. Prior to enrolling in the study, all had been diagnosed with recurrent prostate cancer, indicated by rising PSA after prostatectomy and/or radiation therapy. Twenty-three of the men (83 percent) experienced PSA stabilization; and eight out of 27 (29.6 percent) experienced a PSA decline.

"In contrast to hormonal therapies, PHC was associated with no significant decrease in testosterone levels," reports Dr. Dorff. "So it appears that this non-toxic dietary supplement may be able to offer meaningful benefit without undesirable side effects, such as erectile dysfunction."

The recurrent prostate cancer treatment, Prostate Health Cocktail, is a blend of nutrients, minerals, vitamins and herbs. Previous laboratory tests and clinical trials have indicated that these ingredients—individually and in various combinations—can inhibit prostate cancer cell development, in some cases kill prostate cancer cells, and improve urinary symptoms caused by benign prostate enlargement.

PHC was formulated by physician scientist Jacek Pinski, MD, PhD, an associate professor of Medicine in the Division of Medial Oncology at the Keck School of Medicine of the University of Southern California. An internationally recognized oncologist and laboratory researcher, Dr. Pinski is Co-Director of the Prostate Cancer Research Program at the Norris Center and Hospital, where he combines clinical care with basic research on the biology of prostate cancer.

One out of six American men will be diagnosed with prostate cancer. In the US alone, the disease kills more than 30,000 men annually, making it the second leading cause of cancer death in males. After undergoing prostatectomy (surgical removal of the prostate gland) or radiation, nearly 30 percent of patients subsequently relapse. At this time, no reliably effective standard of care currently exists for them.

Dr. Pinski created PHC to contribute toward an improved recurrent prostate cancer treatment plan for these men and other men. "My hope is that these early research findings will be followed by further evidence that PHC can serve as a non-toxic weapon in the arsenal we use to fight this disease."

For more information about Prostate Health Cocktail (PHC), visit OncoNatural.com.

Released: 04/10/12

Interprofessional Care Teams Improve Clinical Outcomes, Help Address Chronic Health Issues

Coalition Members Discuss Value of Collaboration in Diabetes Patient Care in Journal Article

With so much discussion about what's not working in healthcare today, experts are increasingly pointing to a model of care that is working to improve outcomes for patients. A growing body of research is showing that the concept of "team work" or interprofessional collaboration can fill service gaps, enhance communication and ease the demands on the healthcare system—all of which translates into better care for patients.

The Coalition for Patients' Rights, a national coalition that represents more than three million licensed and certified healthcare professionals, has tracked the proliferation of multidisciplinary care teams as well as barriers to their creation, such as efforts to limit scope of practice. Often referred to as "turf battles," these efforts can restrict the ability of healthcare professionals to make full use of their training and education as well as discourage the interprofessional cooperation that benefits patients. The multidisciplinary approach to healthcare allows professionals from a variety of disciplines to each contribute expertise to help patients. A growing number of academic institutions are providing the next generation of healthcare professionals with opportunities to work in clinical teams as students.

Recognizing the importance of collaborative practice and teamwork, the Interprofessional Education Collaborative, which represents the disciplines of Dentistry, Medicine, Nursing, Pharmacy and Public Health, identified core competencies for collaborative practice and co-led a conference where an action plan for implementing those competencies was designed.

"In the past, interdisciplinary care teams were largely found in geriatric settings. Now we are seeing this patient-centered approach make its way into other care areas for one reason—it works," said Jan Towers, spokesperson for the Coalition for Patients' Rights. "Especially for patients with chronic health conditions, having multiple professionals collaborating together can mean the difference between an optimal outcome or a sub-par outcome."

Research is demonstrating that a holistic healthcare approach can lead to better clinical outcomes in a number of areas. Examples of new research and publications examining the topic of interprofessional collaboration include:

Managing the many aspects of diabetes—Diabetes is a chronic disease with a range of symptoms and complications that can vary from patient to patient. In a commentary accepted for publication in the April 2012 issue of Health and Interprofessional Practice, Coalition leaders examined the ways healthcare providers from a variety of disciplines and backgrounds can collaborate to effectively care for diabetes patients, with each member of the team offering their own expertise.

Leveraging the allied health workforce—The Institute of Medicine (IOM) published a report in December 2011 summarizing stakeholders' discussions of ways to use the allied workforce to improve patient care. They noted that thousands of healthcare workers representing a variety of disciplines make up the allied health workforce. Stakeholders see potential to draw on allied care providers' areas of knowledge and experience as the healthcare system prepares to handle an influx of newly insured patients who gained coverage through healthcare reform.

Advancing science around sleep—In November 2011, the National Institutes of Health released a research plan outlining new approaches to the prevention and treatment of chronic sleep and wakefulness disorders. An estimated 50 million to 70 million United States adults have these types of disorders and interdisciplinary collaboration is being used to help advance research into treatments. The type of healthcare providers working together to improve these disorders can range from oral health experts to psychiatric nurses to cardiologists.

"When patients are able to engage with healthcare professionals across disciplines, it can help better meet patients' needs," said Towers. "It's important that, as more research reflects the value of multidisciplinary care, barriers to accessing a broad spectrum of providers are removed." The coalition raised concerns about patients' access to care being impacted negatively by policymakers' efforts to pass more than 950 pieces of legislation last year affecting the ability of healthcare professionals to provide care.

For patients and consumers who want to read more about multidisciplinary care options, follow the Coalition for Patients' Rights on Twitter @CoPatientRights.

For more information about the Coalition for Patients' Rights, visit patientsrightscoalition.org.

Released: 04/06/12

Duke Medicine's IPIHD Seeking to Support Innovators in Healthcare Delivery Across the World

The International Partnership for Innovative Healthcare Delivery (IPIHD), a support corporation of Duke Medicine, invites healthcare innovators and entrepreneurs globally with operational healthcare delivery models to apply to join the IPIHD Network for support in scaling and expanding.

IPIHD believes that the achievement of global access to cost-effective and high-quality healthcare is a critical component to reducing healthcare delivery inequities in the world. As such, membership is free to healthcare innovators.

Innovators with active operations can apply to join here: http://www.ipihd.org/joining-ipihd/innovators.

Innovators who apply and are accepted into the Network are eligible for support and mentoring programs through IPIHD, including IPIHD's Innovator-Investor Conference. The inaugural Conference will be held on April 15th in Washington DC, and links healthcare innovators with investors in a one-day session including lightning-round pitches, interactive panels, success stories on attracting funding, and networking opportunities.

The Conference is one of four core programs for innovators at the heart of IPIHD. Each program addresses one of the four challenges in scaling businesses identified through extensive research: access to knowledge and networks, organizational expertise, access to funding and capital, and regulatory barriers.

Hosted at Duke University and chaired by Victor J. Dzau, MD, the Chancellor for Health Affairs at Duke University and President and CEO of the Duke University Health System, IPIHD supports healthcare innovators in scaling and replicating their innovations through a select Network of healthcare innovators, industry leaders, and global organizations.

IPIHD was catalyzed by a two-year project at the World Economic Forum, supported by Duke University and McKinsey & Company, that studied transformative examples of healthcare delivery globally, examining both success factors and challenges to scaling and replication.

Released: 04/02/12

Nordic Naturals Introduces 100% Vegetarian, non-GMO Borage Oil for Natural Anti-Inflammatory Support

Nordic Naturals introduces Nordic GLA, a vegetarian borage oil made exclusively from non-GMO cold-pressed borage seed grown in New Zealand. Gamma Linolenic Acid (GLA) is a beneficial omega-6 fatty acid that occurs naturally in plants.

Nordic GLA provides essential omega oil nutrition to vegetarian consumers. The product, available in 4 fluid ounces, provides 480 mg of GLA per serving—the highest level among leading brands—and supports radiant skin, hormonal balance, joint function, and optimal body-fat metabolism. In addition to being 100% vegetarian, Nordic GLA contains no gluten, milk derivatives or artificial colors and is flavor-free.

Borage, also known as starflower, has the highest naturally occurring GLA of any known plant. Like other omega oils, GLA is an essential fatty acid that the human body needs but cannot produce on its own. It is one of two key omega oils in the omega-6 family of essential fatty acids. The other is linoleic acid (LA). GLA promotes the body's natural anti-inflammatory response and supports healthy skin, mood and joints, as well as brain and cardiovascular function.

The development of Nordic GLA reflects Nordic Naturals' commitment to offer innovative new omega oil products in order to meet the varying needs of its customers.

According to Keri Marshall, Chief Medical Officer of Nordic Naturals, "Nordic GLA is effective on its own, or in combination with Nordic Naturals fish oil or algae oil omega-3 products. We now offer borage oil, as a stand alone, independent of fish oil, or professionals can continue to recommend our borage/fish oil blends that we have had for some time such as Pro EFA."

Based in Watsonville, CA, Nordic Naturals is committed to delivering the world's safest, most effective omega oils to help provide the essentials of an extraordinary life. Distributing to more than 35 countries, Nordic Naturals offers more than 150 products in a variety of flavors and formulations, all in line with leading standards for safety, efficacy and sustainability. By providing omega oil supplements for adults, kids, athletes, and pets, Nordic Naturals helps everyone do more of what they love.

To learn more about Nordic Naturals, visit nordicnaturals.com.