In the News

Sexual Transmission of Lyme Disease: a Paradigm Shift

The Microbiome of a Woman's Reproductive Tract May Predict Preterm Birth

Study Highlights MBI Secondary Screening Technology as a Cost-Effective Way to Increase Accurate Breast Cancer Diagnoses

Study Finds Daily Cognizin Citicoline Oral Supplement Improves Attention in Adolescent Males

New Study Confirms Stretta Therapy for GERD to be Safe, Effective, and Durable

Rosetta Genomics Receives Conditional Approval from New York State for Lung Biomarker

Clover Leaf University Has Agreed to Conduct a Clinical Study with Medical Cannabis Research Partners, Haleigh's Hope and Flowering H.O.P.E. Foundation, Using High-CBD Strain - Haleigh's Hope

Sexual Transmission of Lyme Disease: a Paradigm Shift

Editorial analyzes evidence for sexual transmission in animals, humans.

San Francisco, CA, August 26, 2015, If Lyme disease is sexually transmitted, what are the implications for the general population? An editorial published online on August 21, 2015, in the prominent infectious disease journal Expert Review of Anti-infective Therapy explores what happens if Lyme disease morphs from a tickborne illness into a sexually transmitted disease.

Lyme disease is caused by Borrelia burgdorferi, a type of corkscrew-shaped bacteria called a spirochete (pronounced spiro’keet) that is known to be transmitted by ticks. The Lyme spirochete resembles the agent of syphilis, long recognized as the epitome of sexually transmitted diseases. In 2013 the Centers for Disease Control and Prevention (CDC) announced that Lyme disease is much more common than previously thought, with over 300,000 new cases diagnosed each year in the United States. That makes Lyme disease almost twice as common as breast cancer and six times more common than HIV/AIDS.

The editorial was written by two members of the International Lyme and Associated Diseases Society (ILADS), San Francisco internist Raphael B. Stricker, MD, and Canadian microbiologist Marianne J. Middelveen, Mdes. The article reviews the evidence from animal models and human studies of possible sexual transmission of Lyme disease, including a study published in December 2014 that convincingly showed the presence of the Lyme spirochete in semen and vaginal secretions from Lyme disease patients.

The authors point out that contact and/or sexual transmission of Borrelia burgdorferi was demonstrated in mouse and dog models more than 25 years ago. Around the same time, sexual transmission of the Lyme spirochete was demonstrated by Russian researchers in ticks that transmit the disease to humans. Those studies have never been repeated.

“The mouse, dog and tick studies showing contact and sexual transmission of Borrelia burgdorferi have been ignored for too long,” said Dr. Peter Mayne, an ILADS member and Lyme researcher from Australia. “Those studies need to be replicated using modern technology to give us better information about how Lyme disease spreads.”

“The combination of animal model evidence and live spirochetes in human genital secretions strongly suggests that sexual transmission of Lyme disease occurs in humans,” said Ms. Middelveen. “We need to do more research to determine the risk of sexual transmission of this syphilis-like organism.”

Dr. Stricker pointed to a potential paradigm shift in assessing the risk of Lyme disease. “Recognition that Lyme disease can be sexually transmitted would be a game changer,” he said. “We need to re-examine available animal models, including ticks, to learn more about sexual transmission of the Lyme spirochete.”

The Microbiome of a Woman's Reproductive Tract May Predict Preterm Birth

The microbiomes in the reproductive tracts of pregnant women who later had a baby born too soon are significantly different from those of women who delivered full term.

The microbiome, a community of microorganisms on and in the body, is an emerging area of research that may help explain health issues as different as preterm birth, asthma and inflammatory bowel disease.

Researchers at the March of Dimes Prematurity Research Center at Stanford University took weekly samples of the microorganisms from the teeth and gums, saliva, reproductive tract, and stool from 49 pregnant women. They found little change in the bacterial communities in each woman, week to week at each location. But they did find that microbial communities in the reproductive tracts of women who delivered their babies too soon were different from those of women who delivered full term. Those differences were found early in the pregnancies and tended to persist throughout the pregnancies.

"These findings may help us screen women and identify and predict those who are more likely to have a baby born too soon," said David Relman, MD, a professor of microbiology, immunology, and of medicine at the Stanford University School of Medicine and the lead investigator for the research center on this project.

Preterm birth is the number one killer of newborns and serious gaps exist between racial and ethnic groups. More than 450,000 babies are born too soon in the U.S. and the national preterm birth rate is worse than that of most other high-resource countries, the March of Dimes says. Worldwide, 15 million babies are born preterm, and more than one million die due to complications of an early birth. Babies who survive an early birth face serious and lifelong health problems, including breathing problems, jaundice, vision loss, cerebral palsy and intellectual delays.

The research paper "Temporal and Spatial Variation of the Human Microbiota During Pregnancy" was published Aug. 17 in the journal, Proceedings of the National Academy of Sciences. The researchers also found that the patterns of women's microbiomes changed immediately after they delivered their babies, and did not revert back to pre-pregnancy patterns in some cases until at least a year later.

"This might explain why women with closely spaced pregnancies have a higher risk of preterm birth," said Dr. Relman.

The March of Dimes is raising $75 million to support its five prematurity research centers. These unique, transdisciplinary centers bring together the brightest minds from many diverse disciplines -- geneticists, molecular biologists, epidemiologists, engineers, computer scientists, and others -- to work together to find answers to prevent premature birth. In addition to the research center at Stanford in California, the March of Dimes established a research center with a group of universities and hospitals in Ohio, and centers at the University of Pennsylvania, at Washington University in St. Louis, and at the University of Chicago, Northwestern University and Duke University.

"Our nationwide network of prematurity research centers is critical to understanding the unknown causes of preterm birth. This new finding puts in place another piece toward solving the much larger puzzle of preterm birth," says Dr. Jennifer L. Howse, President of the March of Dimes.

The March of Dimes works to improve the health of babies by preventing birth defects, premature birth and infant mortality. The March of Dimes is the leading nonprofit organization for pregnancy and baby health.  For the latest resources and information, visit marchofdimes.org or nacersano.org. Visit prematurityresearch.org for more information about the research centers. Find us on Facebook and Twitter.

SOURCE March of Dimes

Study Highlights MBI Secondary Screening Technology as a Cost-Effective Way to Increase Accurate Breast Cancer Diagnoses

A recent study conducted by Mayo Clinic has determined that the addition of Molecular Breast Imaging (MBI) for women with dense breast tissue resulted in a lower cost per cancer detected than screening with mammography alone. The MBI technology known as LumaGEM, developed and commercialized by Gamma Medica Inc., is a cost-effective tool for detecting early stage cancers in women who have dense breast tissue, which accounts for 45 percent of all women. The study, published in the American Journal of Roentgenology (AJR), entitled "Diagnostic Workup and Costs of a Single Supplemental Molecular Breast Imaging Screen of Mammographically Dense Breasts," found MBI technologies led to more accurate diagnosis rates, and in combination with mammography, resulted in a cost savings of approximately 15 percent.

"The results reinforce the importance of LumaGEM and accelerate our pace to bring the advanced MBI technology to radiologists searching for more accurate tools to diagnose breast cancer," commented Philip Croxford, president and CEO of Gamma Medica. "In addition to the results, which support MBI's promise as a safe, cost-effective, supplemental screening alternative for those with dense breast tissue, women found it to be an easy and comfortable experience."

An additional publication of the Mayo Clinic study in the American Journal of Roentgenology, entitled "Molecular Breast Imaging at Reduced Radiation Dose for Supplemental Screening in Mammographically Dense Breasts," concluded there was a four-fold increase in detection rates as compared with standard mammography when using LumaGEM as a secondary screening method. Unlike mammography, tomosynthesis, and ultrasound—all of which are anatomical imaging tests—the LumaGEM system is a functional imaging modality that highlights the metabolic activity in the breast regardless of tissue density. This allows radiologists to clearly identify early stage cancers. MBI provides equivalent sensitivity, and improved specificity, when compared to MRI, but at roughly one-third of the cost.

About 1 in every 8 women in the United States will develop breast cancer during their lifetime. Nearly 1 in 2 women have dense breast tissue, which masks early stages of cancer in traditional screening methods, often leading to missed opportunities for early intervention. Early detection through screening remains the most reliable method to manage the disease. However, for women with dense breast tissue standard mammography and 3-D tomosynthesis lack the clarity and accuracy to detect early stage cancers.

"These publications emphasize the value of MBI with a safe low-dose capability, a lower cost per cancer detected, and a higher detection rate of breast cancer malignancy that isn't achievable by other breast imaging modalities," said Scott Headland, vice president of sales. "This study underscores the need for Gamma Medica to hasten every effort in growing the adoption of LumaGEM MBI for all women with dense breast tissue."

Source: Gamma Medica, Inc., gammamedica.com

Study Finds Daily Cognizin Citicoline Oral Supplement Improves Attention in Adolescent Males

Results of a double-blind, placebo-controlled, human clinical trial showed that nearly one month of oral supplementation with Cognizin citicoline resulted in improved attention and motor function in healthy adolescent males. The study, published in the August edition of the Journal of Attention Disorders, followed 75 healthy male adolescents who received either a placebo, 250 mg of Cognizin citicoline supplement, or 500 mg of Cognizin citicoline supplement for 28 days. After the 28-day study period, participants who received Cognizin citicoline showed statistically significant increased motor speed, improved attention, and decreased impulsivity compared with the placebo group.

The authors noted the results of this study support previous research that has demonstrated citicoline's positive impact on the brain's frontal lobe, which is still maturing during adolescence. Further, enhanced motor speed, visual selective attention, and reduced impulsivity could prove to be useful in an adolescent population experiencing neural development and increased risk-taking behavior.

"We're pleased with the findings that indicate daily supplementation with Cognizin citicoline enhanced attentional processes in healthy adolescent males," said lead researcher Deborah Yurgelun-Todd, PhD, University of Utah. "This is the first study of its kind that has examined the effects of Cognizin citicoline in an adolescent population—natural supplementation is key, especially during adolescence, when the brain's frontal lobe is still in development."

"The exciting attention-supporting implications of this study are consistent with prior Cognizin citicoline research conducted with healthy adult women, who also experienced improved attention after 28 days of daily Cognizin citicoline oral supplementation," said Danielle Citrolo, registered pharmacist and manager of technical services for Kyowa Hakko USA. "To see strong results, with minimal side effects, in an adolescent population opens the door for additional, ground-breaking research on brain health. We're pleased to know that daily Cognizin supplementation is a promising option for those seeking to positively impact attention and motor skills in healthy adolescents."

Adolescent study participants completed the Ruff 2&7 Selective Attention Test, Finger Tap Test, and the Computerized Performance Test, Second Edition (CPT-II) at baseline and after 28 days of supplementation. In the study, side effects were monitored closely in the pediatric population. It was impressive to find that there were no significant differences in side effects between the treatment and placebo groups, consistent with previous studies that found few side effects associated with citicoline supplementation in adults.

"Although we did not measure dopamine in this study, it is likely that citicoline may increase dopamine activity in healthy adolescent males and result in the changes observed in this study," said Dr. Yurgelun-Todd. "Citicoline has been shown in previous studies to increase levels of dopamine, which may be one of the mechanisms through which citicoline improves motor and attentional functions."

Though previous studies have examined improvement of deficits in motor and attentional abilities, this most recent study, where participants took daily supplements of either 250 mg or 500 mg of Cognizin citicoline, measured the enhancement of abilities in individuals with normative functions in the respective domains.

For a brief, animated tutorial on how Cognizin citicoline works in the brain, please click here.

Source: Kyowa Hakko USA; kyowa-usa.com

New Study Confirms Stretta Therapy for GERD to be Safe, Effective, and Durable

Stretta Therapy, a non-ablative radiofrequency treatment for GERD, was called "effective, safe, and durable following 15 years of worldwide use" and cited as a "viable complement or alternative to medical and surgical treatment" in a newly published clinical review of endoscopic techniques for gastroesophageal reflux disease (GERD). Authors Wai-Kit Lo, MD, MPH, and Hiroshi Mashimo, MD, PhD, of Harvard Medical School, examined multiple alternatives to PPI therapy or surgery, including Stretta and other devices such as endoscopic plication and suturing, as well as injectable and implantable bulking agents. Their findings have been published online (in advance of print) in the Journal of Clinical Gastroenterology.

GERD affects an estimated 20 percent of adults, and although PPI therapy is the accepted standard of care, there are approximately 40 percent of patients who still experience symptoms despite PPI treatment. The authors explain that the main anatomic and neuromuscular defects underlying GERD are not addressed by PPIs. They also recognize a rising awareness of adverse effects associated with long-term PPI use and a decline in the volume of surgical fundoplication, noting that these factors underscore the need for alternative approaches to complement medical and surgical treatments.

There are several endoscopic techniques available. However, recognizing that data about these therapies has been mixed, the authors undertook a critical assessment of these technologies to better understand the role that they play in the management of GERD symptoms.

In their evaluation of treatments, authors noted that Stretta has the longest period of clinical evaluation, observing that Stretta data includes a meta-analysis of 1,441 patients across 18 studies, and four randomized-controlled trials. They referenced that Stretta earned the strongest grade recommendation by the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) in guidelines for endoluminal treatment of GERD in 2013. They also reported that newer studies show that the effect of Stretta remains durable at 8 and 10 years after initial therapy. Additionally, recent guidelines from the ASGE came out in support of a consideration of endoscopic treatments for GERD.

Regarding Stretta, the authors concluded that, "A wealth of research has demonstrated the safety, efficacy, durability, and repeatability of Stretta treatment. Most important, it does not preclude alternative treatments including medical, surgical, or repeat radiofrequency treatments, and may also provide potential treatment for patients who have failed fundoplication. Stretta is likely the least expensive alternative to medical therapy. This technique should be considered a viable complement or alternative to medical and surgical treatment of GERD symptoms."

Source: Mederi Therapeutics

Rosetta Genomics Receives Conditional Approval from New York State for Lung Biomarker

Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based and other molecular diagnostics, announces that the Company was granted conditional approval status for its ROS1 lung cancer biomarker by Fluorescence in situ Hybridization (FISH) assay from the New York State Department of Health (“NYSDOH”) under the Company’s Molecular Oncology permit. New York is the only U.S. state that requires an independent regulatory review process for laboratory-developed tests. With this conditional approval, Rosetta Genomics’ ROS1 by FISH assay is now available in all 50 states. In making the assay available pending final approval, the NYSDOH requires the Company to provide any additional information they request within 60 business days.

“Through our recent acquisition of PersonalizeDx, we have a best-in-class FISH testing program that provides informative FISH results in 98 percent of cases with a rapid turnaround time of 3-4 days. Combining the ROS1 lung cancer biomarker with FDA-approved ALK FISH and EGFR PCR testing provides actionable genomic targets, which enhances the oncologist’s treatment decision options,” stated Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics.

Rosetta Genomics offers a comprehensive test menu in lung cancer. Treating physicians have an array of options to choose from, whether they want to confirm primary lung cancer diagnosis, clarify tumor subtype, perform a full oncogenomic profile or focus exclusively on lung-specific biomarker targets via NGS, FISH, PCR and/or IHC. Rosetta Genomics will continue to pursue New York State approval for its entire menu of test offerings.

Clover Leaf University Has Agreed to Conduct a Clinical Study with Medical Cannabis Research Partners, Haleigh's Hope and Flowering H.O.P.E. Foundation, Using High-CBD Strain - Haleigh's Hope

Clover Leaf University, a Department of Higher Education approved occupational program focused on providing the cannabis industry with an educational standard of best practices, and corporate business standards, as well as providing training for cannabis industry workers, and Flowering HOPE Foundation, a Colorado based 501(c)(3) nonprofit announced a joint program to conduct a clinical study on the high-CBD epilepsy therapy known as Haleigh's Hope.

The study, scheduled to begin this fall, will examine the safety of Haleigh's Hope for use in treating childhood epilepsy. The study is slated to work with 50 patients over the course of the trial. According to the strain's developer Jason Cranford, Haleigh's Hope has been used effectively to reduce the symptoms of epilepsy in more than 300 children nationwide.

Cranford is Founder of the Flowering HOPE Foundation, a Health Care Associate for the Society for Cannabis Clinicians, as well as an expert botanist who specializes in the organic cultivation of medical grade cannabis and the development of highly medicinal cannabis infused products. Over the past four years, Cranford has successfully bred and produced a 95 percent CBD plant that has been verified through two independent labs. He has developed several CBD rich infused products including Haleigh's Hope and Cannatol.

"The United States is severely lacking in clinical research on the safety, efficacy and impact of medical marijuana on specific disease states. While there is a massive amount of anecdotal evidence on the role high-CBD, low-THC, treatments such as Haleigh's Hope have on diseases such as childhood epilepsy, Crohn's disease, multiple sclerosis and even cancer; there are no peer reviewed published clinical trials in the US on this type of therapy using whole plant cannabis extract. This is the first study of its kind and we expect the program will be completed quickly and successfully," said Jason Cranford, creator of Haleigh's Hope.

The group intends to apply for a grant to fund the study, which will be performed by Colorado licensed physicians, epitologists, and pediatric neurologists.