Dr. Mary Fletcher and the ME/CFS research team at the Institute for Neuroimmune Medicine at Nova Southeastern University have received a very large grant ($1.9 million) from the National Institute of Neurological Disorders and Stroke at the NIH. This grant will look for biomarkers in, get this, men with Chronic Fatigue Syndrome. The grant builds on the work provided by $10 million (that’s right, ten million dollars) worth of work on Gulf War Syndrome – a syndrome populated mostly by men. It may be first study devoted to specifically understanding this disease in men.
It’s about time! The NSU research group has been focused mainly on women, and this big grant will balance that out. ME/CFS is often spoken of as a “woman’s disorder”, but men make up twenty to forty percent of the million people in the U.S. believed to have Chronic Fatigue Syndrome. (The press release, interestingly, suggests that this figure is too low. One wonders who they feel the epidemiological studies missed.)
Study to Illuminate New Treatment Possibilities
The goal is to use those biomarkers to select existing drugs to be repurposed to treat people with ME/CFS. They’re not just whistling Dixie down in Miami about this. A similar effort in GWI in men has produced a treatment that’s now in phase 1 clinical trials. Dr. Klimas reported they’ll be performing a series of GWI clinical trials over the coming 2 years. The best way to keep abreast is to watch NSU’s web site .
They clearly have specific drugs in mind. The Klimas-Fletcher-Broderick team has been circling around the subject of repurposing drugs for some time. Their focus on neuro-inflammatory and neuro-degenerative disorders such as ME/CFS, GWI, Parkinson’s disease, and Multiple Sclerosis suggests they may be considering a wide variety of drugs. The focus on repurposing in this grant suggests they’re getting closer to clinical trials.
Check out the abstract of the study and you can see what big goals the group has. They state they’ve “developed a dynamic model to identify the mediators of persistence and relapse” in ME/CFS. In other words, their modeling is aimed at identifying no less than why ME/CFS persists in men and what causes patients to relapse, and then finding ways to restore the homeostasis (i.e., the health) that has been lost.
This work builds on Broderick’s modeling work which suggested that different immune-endocrine pathways are at work in men and women in ME/CFS. That work suggests estrogen plays a major role in the endocrine instability in women with ME/CFS, and that testosterone plays a protective role in men.
Dr. Fletcher’s goal to precisely pin down the differences between men and women with ME/CFS suggests they already have a good idea what they are, and now it’s just a matter of zeroing in on them.
They will also use the grant to identify gender differences as they relate to their ability to keep the lid on latent viruses in the body.
Pathways to Neuroimmune Disease Being Mapped Out
The deeper the NSU team digs into ME/CFS and GWS the more interesting it gets. ME/CFS and GWS look very similar; not only are their symptoms — highlighted by post-exertional relapse — similar, but they also share common autonomic, inflammatory, and cellular immune dysfunctions. Digging deeper into the molecular basis of these disorders has revealed fundamental differences, however. Differing gene expression and cytokine responses to exercise indicate that strikingly different pathways at the molecular level are producing similar-appearing diseases on the surface.
Will the same pattern extend to gender differences in ME/CFS? Are very different pathways of disease creating similar disorders on the surface? Could men and women with ME/CFS – at the molecular level have different diseases? Thus far the answers to these questions may be yes.
Given the difficulty of getting enough patients for normal studies, it will probably much harder to get to fill a study focusing on men. Men between the ages of 18 and 75 who are interested in enrolling in the study can call (305) 275-5450.
Regarding whether you need to live in the area to be in the study Dr. Klimas reported “No, you can live anywhere if you are able to travel to South Florida for the screening (1/2 day) and the study (2 days). However the study has very limited travel funds, and the screening visit is a week or two before the study visit to allow for labs to come back that determine if the person is eligible. We are still working out some of the logistics. The study coordinator is Fanny Collado, RN and her best contact is by email firstname.lastname@example.org”
A Friend to ME/CFS Emerges
A two million dollar endowment from the Schemel Family Foundation allowed Dr. Fletcher to move herself and the E.M. Papper Laboratory of Clinical Immunology to Nova Southeastern and become the first Schemel Professor for Neuroimmune Medicine.
Other NIH funded studies
While we’re at it let’s take a brief look at some other NIH studies Dr. Klimas’s Institute of Neuroimmune Medicine is engaged in.
Good Day/Bad Day Study Extension
In this extension of the Good Day/Bad Day (GD/BD) study examining ME/CFS patients on their good days and their bad days, biomarkers are the key again. This study will attempt to identify the mechanisms behind the altered immune functioning highlighted in the first GD/BD study.
Their goal is build a gene expression assay that identifies the key markers driving the neuro-immune-endocrine mess that is ME/CFS.
They’ll also assess the effectiveness – in the lab – of targeting immunotherapies at the IL-15 cytokine to increase natural killer cell functioning. They are jazzed enough regarding the IL-15 cytokine to state that they believe it will qualify for clinical trials in ME/CFS.
This study, then, could produce a diagnostic test for ME/CFS and identify an immunotherapy that increases NK cell functioning. This study is two-thirds done and ends in 2015.
The Molecular Basis of the Exercise Problems in ME/CFS
This study focuses on the ‘regulatory’ failure they believe occurs during exercise in ME/CFS. They believe ME/CFS, at least in part, derives from a failure to properly regulate the immune, endocrine, and neurological systems during exercise. Their past studies, for instance, reveal that convoluted immune networks in people with ME/CFS have replaced smaller and more effective immune networks in healthy people.
In this study they examine the molecular ramifications of hitting the immune, endocrine, and neurological systems in ME/CFS patients hard with an exercise stressor. Then they’ll integrate those molecular findings into an interpretable map showing how the different systems link together in ME/CFS and in healthy controls. Then they’ll identify weak links in the “wiring”.
Using computer simulations they’ll assess the effectiveness of different treatments in repairing these weak links and resetting homeostasis; i.e., returning the system to it’s normal resting state (health) in which the normal response to exercise found in the healthy controls occurs….(That would be nice!).
This study ends in 2015.
Dr. Klimas States Critical Mass Being Reached at NSU
Dr. Klimas started the Institute for Neuro Immune Medicine at NSU just a couple of years ago but the program has grown rapidly. Now she reports that a critical mass is being reached in the program.
“We are very excited about these studies. The bottom line is that we are now funded to study the dynamics of relapse in men AND women with GWI OR ME/CFS with sufficient funding to develop novel treatment strategies in both illnesses and both sexes. We are fairly far along with men who have GWI and women with ME/CFS, and as a result are already proposing the treatments suggested by our work as phase 1 studies to funding agencies and philanthropists. We have the new NIH grant to study men with ME/CFS and a new VA grant to study women with GWI. We also have a big DoD grant to model GWI in animals to test many different treatment strategies with funding through to the first phase 1 study in GWI. It’s the critical mass we had been hoping for, now have in hand, and are pressing hard for the translational studies that follow.” Dr. Klimas
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