Help Simmaron Research AMPlify Therapies for ME!!

Author:

AMPlify-therapy-for-ME

Simmaron Research Foundation 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.

Collaborators

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.

Fundraising

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 very generous donors so far. We have a goal of raising $20,000 during this fundraising effort!

DONATE HERE

The Data Study

The Responder Study takes advantage of an unfortunate year-long hiatus in availability of Ampligen, meaning that the patients are restarting medication 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 response to therapy in order to understand this patient population more completely.” Our goal is to publish data about treatments.

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.

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!

DONATE HERE

 

Facebook
Twitter
WhatsApp
Email

Latest News

Happy Pride Month 2022 with rainbow ribbon in a heart

#MEAction Recognizes & Celebrates Pride Month 2022!

#MEAction recognizes and celebrates Pride Month! As a community that welcomes and encompasses all, this Pride Month, we asked members of our LGBTQIA+ community to share what Pride means to them and what they have learned from this movement that they bring with them to the ME movement. Here are a few responses: Kristina Osobka-Stier

Read More »
Severe ME Artist Project 2022 over swatches of gold paint

Severe ME Artists Project 2022!

#MEAction is once again excited to announce our Severe ME Artists Project 2022 that will feature work from those within the severe ME community and will be in recognition of Severe ME Day on August 8th! This project will be an opportunity for those with severe ME to showcase their art work (whether it be

Read More »

Help keep our work going

We rely on donations from people like you to keep fighting for equality for people with ME.

Donate

Get actions alerts and news direct to your inbox

You can choose what you want to be kept up to date on.

Subscribe
Scroll to Top