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A Year of Progress at Simmaron

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By Courtney Miller • www.ProHealth.com • December 26, 2013


A Year of Progress at Simmaron

From Simmaron Research

Dear Friends,

As we reflect upon 2013, we are grateful for the generosity of our supporters, humbled by the strength of our patient community and hopeful about new research studies being pursued. Science is on the cusp of new understanding of ME/CFS driven by research studies and collaborations to which Simmaron is proud to have contributed.

We are excited about the foundation's accomplishments in its first two years, having completed our portion of 9 research studies and begun 4 more. We eagerly await publication of Dr. Ian Lipkin's groundbreaking results, which he previewed for the community this fall. 2014 will also see publications of more of our finished collaborations.

We need your continued financial support going into 2014 as we begin several new scientific initiatives.

First, Simmaron Research is proud to announce that we are in the initial stages of a 2 year ME/CFS Physician Fellowship. For some time now, we have been looking toward the future at the critical gap in the number of experienced ME/CFS physicians to treat patients. Simmaron is uniquely positioned to take leadership in training fellows given Dr. Daniel Peterson's expertise in diagnosis and treatment of CFS and his understanding of clinical research.

Next, we are initiating our first study on genomics of natural killer (NK) cells. Led by our Scientific Director, Dr. Isabel Barao, Ph.D., this study will examine immune response genes expressed by NK cells, macrophages, and B cells in families with CFS. Genomic and functional analysis of immune receptors in chronic fatigue syndrome, is a collaboration with University of Nevada, Reno, National Cancer Institute, and Sierra Internal Medicine.

Simmaron has also been awarded access to samples from the NIH directed XMRV investigation for our study entitled, Tick and Arthropod-Borne Disease in Post-Infectious Fatigue. We will begin work on this study in the New Year. This study has the potential to aid in subsetting patients for treatments and identifying a role of infection in precipitating ME/CFS.

Work has also begun on our study to investigate the value of T-cell gene rearrangement testing in identifying a subset of ME/CFS patients who are at risk of developing lymphoma and other cancers, for diagnostic and treatment purposes. And in response to rural health needs, Simmaron will endeavor to develop a repeatable model for a hepatitis C virus (HCV) clinic.

2013 marked the first year of our popular Internship Program which supported 5 interns! We have started a number of data analysis projects to generate pilot data on treatment protocols and biologic markers to inform future grant submissions and clinical trials, assisted by these young, budding scientists.

While building capacity this year, Simmaron continues to be a lean organization focusing our resources on a strong science team. We are building our Scientific Advisory Board with the addition of Dennis F. Mangan, Ph.D. Some of you may recognize his work as the Chair of the Trans-NIH Working Group for CFS, where he organized the National Institutes of Health's first State of the Knowledge Scientific Workshop on ME/CFS in more than a decade. Dr. Mangan has already brought great insight to our research initiatives.

2013 additions to our science team include Scientific Director, Isabel Barao, Ph.D., who is a cancer immunologist and adjunct assistant professor at University of Nevada Reno. Gunnar Gottschalk, SNC '11, is now Simmaron's Research Manager, and we have recently hired Holly Evers as our new Administrative Director.

With the New Year upon us we would like to again thank you for your generous contributions of our scientific efforts. Our new initiatives need your continued support, and if you are able, we are pleased to invite you to make a year-end contribution of any size to propel us forward. You may send donations to the address below, or make them online. Thanks to you, we will continue our work to reach the goal where ME/CFS is a treatable and well-understood illness and where patients have access to care that truly improves their quality of life.

All of us at Simmaron wish you and your family a wonderful, healthful new year.

Gratefully,

Courtney Miller, President

For the Board of Directors

________________

New Scientific Study Initiatives

ME/CFS Physician Fellowship - Under the leadership of Dr. Peterson, Simmaron Research has created a 2 year physician fellowship program to train physicians to recognize and treat patients with ME/CFS and develop expertise in this field.

Genomic and functional analysis of immune receptors in chronic fatigue syndrome - In this study, Simmaron Research will determine whether genetic variations in the genes coding for immune receptors expressed by natural killer (NK) cells, macrophages and B cells, play a role in chronic fatigue syndrome (CFS) risk and pathogenesis. Findings could support diagnosis and development of new therapeutic interventions.

Tick and Arthropod-Borne Disease in Post-Infectious Fatigue - This study will assess the similarities and differences in exposure to multiple tick and mosquito-borne pathogens among geographically diverse patient cohorts, with the potential to aid in subsetting and identifying a role of infection in precipitating CFS/ME.

Multisite Assessment of the Prevalence of Clonal T-cell Receptor Gamma Gene Rearrangements in CFS patients - This study will investigate the value of T-cell gene rearrangements in identifying a subset of patients who are at risk of developing lymphoma and other cancers, for diagnostic and treatment purposes.

Clinical Data Analyses - We have started data analyses of clinical charts to generate pilot data for possible publications and grant submissions for on the pathogenesis of CFS and therapeutics. Initial clinical data analyses include the drugs Cidofovir, Ampligen and IVIG.

________________

Ongoing Scientific Study Initiatives

Griffith University Spinal Fluid study - As a complement to the Lipkin study seeking to identify pathogens in spinal fluid, this study is assessing the role of miRNAs and immune abnormalities in CFS patients compared to controls. This investigation is groundbreaking, and seeks to explain the neurological symptoms of CFS. Led by Dr. Sonya Marshall-Gradisnik, Ph.D., the study will be completed in early 2014.

CDC's Multi-Site Clinical Assessment of Chronic Fatigue Syndrome - year 3 - Sierra Internal Medicine is collaborating in the CDC's 7-site clinical assessment of CFS to characterize patients in clinical practices of clinicians with expertise in ME/CFS. The data collected using a standardized approach from expert clinical practices will be used by CDC to address the CFS case definition and to study sub-groups to improve therapy and allow the underlying biology to be discovered. CDC's Dr. Elizabeth Unger is charting a new path at CDC to scientifically research the illness grounded in the field's expert physicians.

_______________

Pending Publication

Epidemiological Survey - This study is aimed at following up with individuals who were diagnosed with CFS in a number of sites, including those diagnosed more than 10 years ago. The survey seeks to learn if patients have developed cancers, autoimmune diseases, or other disorders at a higher incidence. Results will be published in mid 2014.

Pathogens and Pathogenic Mechanisms in Cerebrospinal Fluid of ME/CFS - This study seeks to detect Pathogens and Pathogenic Mechanisms in the cerebral spinal fluid of patients with ME/CFS using the known and novel pathogen arrays at The Center for Infection and Immunity at Columbia University. Results will be published in early 2014.

Nested Pathogen study in Cerebrospinal Fluid of Cancer Subset of ME/CFS - This study parallels the Columbia University investigation of the cerebral spinal fluid of a subset of ME/CFS patients who went on to develop lymphoma or other cancers. Results will be published early 2014.

Post-Infectious Cardiomyopathy Study - This study investigates four subjects from Northern Nevada who developed a form of dilated cardiomyopathy with an unknown cause. We are awaiting publication of the results.

_______________

Published

Persistent human herpesvirus-6 infection in patients with an inherited form of the virus. - The data presented in this publication, sponsored by the HHV6 Foundation, document that some individuals with CIHHV-6 are infected persistently with exogenous HHV-6 strains that lead to a wide range of neurological symptoms. Journal of Medical Virology, July 25, 2013.

XMRV and MLV in Chronic Fatigue Syndrome - The study, funded by the NIH and led by Dr. Ian Lipkin, created one of the best characterized, multi-site set of patients and controls in CFS. The results of this study indicated that there was no connection between CFS and XMRV or MLVs, and were published in the Journal of Molecular Biology on September 18, 2012.

Cytotoxic lymphocyte microRNAs as prospective biomarkers for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis - The objective of this study was to determine the association between miRNAs in cytotoxic cells andCFS/ME. There was a significant reduction in the expression levels of miR-21, in both the NK and CD8(+)T cells in the CFS/ME sufferers. Additionally, the expression of miR-17-5p, miR-10a, miR-103, miR-152, miR-146a, miR-106, miR-223 and miR-191 was significantly decreased in NK cells of CFS/ME patients in comparison to the non-fatigued controls. Journal of Affective Disorder, December 2012.

A Double-Blind, Placebo-Controlled, Randomized, Clinical Trial of the TLR-3 Agonist Rintatolimod in Severe Cases of Chronic Fatigue Syndrome (Ampligen) - A Phase III prospective, double-blind, randomized, placebo-controlled trial comparing twice weekly IV Ampligen versus placebo was conducted in 234 subjects with long-standing, debilitating CFS/ME at 12 sites. Ampligen produced objective improvement in ET and a reduction in CFS/ME related concomitant medication usage as well as other secondary outcomes. PLOS One, March 14, 2012



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