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Help Simmaron AMPlify therapies for M.E.!

Simmaron is fundraising for its one-of-a-kind study to analyze data from ME/CFS patients who respond to treatments like Ampligen®, IVIG, and cidofovir. The goal of the study is to build a scientific roadmap for getting a first medication approved by the FDA for our disease.

Which patient subset responds to immune-based treatments, like Ampligen and IVIG?

Or anti-viral treatments like cidofovir?

Which subset responds to saline or amino acid infusions?

What measures demonstrate response?

These therapies are currently in use at Sierra Internal Medicine in Incline Village under individualized treatment plans by Dr. Daniel Peterson, and Simmaron’s role is to compare the results of 3 different treatment groups in a prospective analysis that can give us clues to measuring treatment response vigorously.


Simmaron is collaborating with Maureen Hanson, PhD of Cornell, who will lead scientific research on patient samples; the US Centers for Disease Control, which will lead statistical analysis; and Sierra Internal Medicine, where patients receive the treatments.


The funds we raise will pay for data extraction, analysis, and sample preparation to study who responds, what markers track improvement in how patients feel, and what characteristics can be used to refine patient enrollment in double-blind trials. The funds are not covering individuals’ costs for the treatment itself.

The study has a budget of $200,000, and some of the elements have secured funding from generous donors so far. We have a goal of raising $20,000 during this fundraising effort!

The Data Study

The Responder Study takes advantage of an unfortunate year-long hiatus in availability of Ampligen, meaning that the patients are being tracked from a baseline of not having that treatment for more than a year and the functional decline that came with the hiatus.

The study will include 13 patients who resume Ampligen, 13 who receive other intravenous therapies, and 13 patients who receive no infusion-based treatments, matched for age and sex.

Our research team will track the following measures before, during, and at 52 weeks for the different treatment arms:

  • NK cell (natural killer cell) function
  • Cytokine expression
  • Multiple symptom surveys
  • Exercise tolerance test
  • Cornell-designed research protocols

Gunnar Gottschalk, Simmaron Research Fellow, describes the urgency of this study, “It is imperative that we publish findings that track an individual’s response to therapy in order to understand this patient population more completely.”

NIH Presentation

During NIH’s recent workshop for Young ME/CFS Investigators, Gottschalk presented on the clinical experience of 25 patients treated with Ampligen from 2011 to 2017 at Sierra Internal Medicine. The presentation showed “…significant and sustained clinical reduction in both the physical and neurological symptoms following Rintatolimod (Ampligen®)”, including improvement in physical functioning, pain and energy after 6 months of treatment.

Poster Presentation at NIH Accelerating Research for ME/CFS Scientific Conference, April 2019

Informing A Pathway to Approval

We know first-hand that patients need well-designed treatment trials to achieve FDA approval for a first ME medication. Rigorous data analysis, starting with this study, can provide a building block to designing rigorous placebo-controlled trials that have a stronger chance of approval, and ultimately attract pharmaceutical companies to the disease.

Simmaron is leading the effort to turn science into treatments for patients, and your support powers our work. Help us reach our goal of raising $20,000 in the next month to fund an important part of this study!

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  • Jilly

    April 24, 2019 at 10:42 pm - Reply

    I cannot speak for Ampligen, but I can for cidofovir. I have had CFS/ME since 1992 after a bout of mono and have cycled through the disease getting continuously worse since then. I was a patient of Dr. Martin Lerner in Michigan for a couple years and did 9 rounds of Cidofovir with him.

    It was a rough treatment, BUT — I went from having to travel through the airport in a wheelchair TO RUNNING 5+ MILES ON A TREADMILL. It was the best and longest remissive state I have been able to achieve with this disease.

    Unfortunately, a shocking personal event rocked my world 7 months following treatment (my husband left me for another woman) and the ensuing long-term grief and anxiety, in addition to pushing myself to my limits in the gym caused me to crash again, and crash hard. I have been in a semi permanent crash state (bed and house bound) since then (2015). However, I did have such incredible results from Cidofovir like none other. To note is that I have been with Dr. Montoya’s clinic at Stanford since Dr. Lerner died, and am on their protocol. But nothing has been nearly as effective as the Cidofovir.

    Feel free to contact me.

  • Gregory Cutler

    April 25, 2019 at 1:03 am - Reply

    Can you further elucidate how such a small study will induce the maker of Ampligen to fund a Phase 3 Study when they have refused to do so in the past?

    • Cort Johnson

      April 25, 2019 at 7:36 pm - Reply

      Hemispherx has hardly been the cat’s meow for ME/CFS The study will, hopefully, however, indicate how and why Ampligen works when it does.If the study can show which immune factors are reduced prior to Ampligen treatment and then recover with Ampligen treatment it may be identify a subset of patients who will respond. That could enable Hemispherx to a) target patients and b) enable them to fund a smaller study than otherwise.

      We shall see!

      Besides that the study could simply help us understand what went wrong in patients with acute infectious onset.