Ampligen Takes Big Step Forward - Becomes First Drug Approved Anywhere For Chronic Fatigue Syndrome

Cort

Founder of Health Rising and Phoenix Rising
Staff member
Does 60 mean I'm able to feed and water and clothe myself except for the days I can't get off the couch all day and still don't feel up to cooking? I don't know.

I do know that I can do more than some but I can't maintain much and my life is curtailed pretty significantly.

Welcome, @Anita Patton. Reading your post gave me a thirst for Ampligen. Even though I am not sure I'd meet the criteria, my life sure would look different if it worked for me the way it did with you. Guess I will stick with cat's claw and NSAIDs for now
I imagine that you could squeeze in there. :)
 

SueS

Active Member
Oh, thanks, @Cort!

(Says something about my violent need for validation that your nod for my admittence into the 60 club makes me feel ... well, validated, hehe)
 

voner

Active Member
@Cort,

I thought your reporting of this:

Hemispherx reported it's at long last identified a subset of high responders to Ampligen and will present a paper to that effect at the IACFS/ME conference in October.

Was very significant. Being able to identify a subset of people with ME/CFS that will respond to Ampligen could contribute a lot to defining that subset's disease process, in addition to providing significant symptom relief. That's a big first step. I look forward to October's presentation.
 

Cort

Founder of Health Rising and Phoenix Rising
Staff member
@Cort,

I thought your reporting of this:



Was very significant. Being able to identify a subset of people with ME/CFS that will respond to Ampligen could contribute a lot to defining that subset's disease process, in addition to providing significant symptom relief. That's a big first step. I look forward to October's presentation.
You what's the really weird thing - Every conference that I can remember has featured an Ampligen presentation - and they've generally been quite boring. Now that we've got something really significant - no presentation!

It looks like its going to end up in the poster section...:arghh:

I like the conference but nothing from Ron Davis or the Open Medicine Foundation's Severely Ill project made it to a presentation at the conference...:banghead:

That I really don't get.
 

voner

Active Member
You what's the really weird thing - Every conference that I can remember has featured an Ampligen presentation - and they've generally been quite boring. Now that we've got something really significant - no presentation!

It looks like its going to end up in the poster section...:arghh:

I like the conference but nothing from Ron Davis or the Open Medicine Foundation's Severely Ill project made it to a presentation at the conference...:banghead:

That I really don't get.

IS there a publicly available schedule for the conference up yet?
 

Ron

Member
October 27, 2016. IACFS/ME Conference Keynote Presentation
New ME/CFS Developments at the National Institutes of Health


Dr. Whittemore received her Ph.D. in anatomy from the University of Minnesota, followed by post-doctoral work at the University of California, Irvine, and a Fogarty Fellowship at the Karolinska Institute in Stockholm, Sweden. She was on the faculty of the University of Miami School of Medicine in The Miami Project to Cure Paralysis prior to working with several non-profit organizations including the Tuberous Sclerosis Alliance, Genetic Alliance, Citizens United for Research in Epilepsy (CURE), and the National Coalition for Health Professional Education in Genetics (NCHPEG). She also served a four-year term on the National Advisory Neurological Disorders and Stroke Council.

Dr. Whittemore has been a strong voice for increasing the research commitment for ME/CFS at the NIH. This includes launching a research protocol at the NIH Clinical Center to intensively study individuals with ME/CFS and re-invigorating the efforts of the Trans-NIH ME/CFS Research Working Group. The working group, co-chaired by Dr. Whittemore, consists of representatives from 23 NIH institutes that help to support extramural ME/CFS research. Dr. Vicky Whittemore is also the NIH representative to the U.S. Department of Health and Human Services' Chronic Fatigue Syndrome Advisory Committee.


PLENARY SPEAKER: Dr. Øystein Fluge, Chief Physician, Department of Oncology, Haukeland University Hospital, University of Bergen, Norway
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Dr. Fluge is Chief Physician in the Department of Oncology at Haukeland University Hospital, University of Bergen, Norway. He received his medical degree in 1988 from the University of Bergen and has specialized in oncology since 2004. He has conducted research at the Surgical Institute and Department of Molecular Biology, University of Bergen and has been funded as a Research Fellow by the Norwegian Cancer Society.
In 2004, Dr. Fluge and his colleague, Dr. Olav Mella, a neurologist at the same institution, noticed that a patient’s ME/CFS symptoms improved substantially while undergoing chemotherapy treatment for a concurrent diagnosis of lymphoma. This was followed by a pilot study in 2009 with positive results. In 2011, Dr. Fluge, Dr. Mella, and their colleagues published a randomized double-blind placebo-controlled trial of rituximab in 30 ME/CFS patients demonstrating that two-thirds of the intervention group experienced moderate to major improvements in their ME/CFS symptoms. For a medical condition with no disease-modifying treatments, this was a ground-breaking study. Currently, they are in the midst of attempting to replicate their results in a larger Phase III multi-center study in Norway.
12th International IACFS/ME Biennial Clinical and Research Conference
Emerging Science and Clinical Care
Thursday, October 27th


9:30 am – 12:30 pm
Professional workshops (run concurrently; attendees select one only)


Review of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, Fibromyalgia and Multiple Chemical Sensitivities/Environmental Sensitivities: Office Assessment and Management
Alison Bested, M.D., F.R.C.P.C.
Clinical associate professor, Department of Medicine, University of British Columbia

Acute and Chronic Enteroviral Infection
John Chia, M.D.
UCLA School of Medicine

How Cardiopulmonary Exercise Testing Informs Pathology and Treatment
Staci Stevens, M.A.
Founder, WorkWell Foundation

1:30 pm – 4:30 pm
Professional workshops (run concurrently; attendees select one only)


Behavioral Assessment and Treatment of ME/CFS and Fibromyalgia
Fred Friedberg, Ph.D.
President, IACFS/ME
Research Associate Professor, Stony Brook University
Founder and Editor, Fatigue: Biomedicine, Health and Behavior

Diagnosing and Treating Orthostatic Intolerance
Peter Rowe, M.D.
Johns Hopkins University School of Medicine

NIH Grant Writing Workshop
Vicky Whittemore, Ph.D.
Program Director, Channels, Synapses and Circuits
National Institute of Neurological Disorders and Stroke


General Session Agenda-Friday, October 28th

8:00 am – 8:15 am
Welcome and Introduction
Fred Friedberg, Ph.D.
President, IACFS/ME
Research Associate Professor, Stony Brook University
Founder and Editor, Fatigue: Biomedicine, Health and Behavior

8:15 am – 9:00 am (last 15 min. are Q and A)
Plenary Session
B-lymphocyte depletion and disease mechanisms in ME/CFS
Oystein Fluge, M.D.
Chief Physician, Department of Oncology,
Haukeland University Hospital, University of Bergen, Norway

Paper Sessions following short paper presentations each 12 minutes in length, presenters will field questions written on cards by the audience and given to the chair as time permits.

9:00 am – 10:15 am
Session 1: The Latest Research in Immunology and the Microbiome
Session Chair: Sonya Marshall-Gradisnik, Ph.D.
Professor of Immunology, Griffith University, Australia

Exercise testing highlights differences in cytokine profile and network between patients with chronic fatigue syndrome and healthy sedentary participants
Francois Haddad, M.D., Director, Biomarker and Phenotypic Core Laboratory, Stanford Cardiovascular Institute

A panel of biomarkers accurately identifies CFS/ME patients and contributes to the understanding of the pathophysiology of the disorder
Kenny L. De Meirleir, M.D., Nevada Center for Biomedical Research at University of Nevada

A profile of circulating cytokines is associated with disease severity in chronic fatigue syndrome patients
Jose G. Montoya, M.D., Stanford University School of Medicine

Alterations in the enteric bacterial and viral microbiome in ME/CFS
Ludovic Giloteaux, Ph.D., Department of Molecular Biology and Genetics, Department of Microbiology, Cornell University

10:15am – 10:45 am
Break/Visit Exhibits

10:45 am – 12:15 pm
Session 2: Treatment Studies and Clinical Practice
Chair: Daniel Peterson, M.D.
Griffith University, Gold Coast, Australia
Owner, Sierra Internal Medicine, Incline Village, Nevada

Reflections on the rituximab trials
Olav Mella, M.D., Department director/professor, Haukeland University Hospital, Oslo, Norway

Synergy Trial for CFS – a phase 2 study of low-dose methylphenidate plus mitochondrial support
Lucinda Bateman, M.D., Bateman Horne Center of Excellence

N-Acetylcysteine alleviates cortical glutathione deficit and improves symptoms in CFS:
An in vivo validation study using proton magnetic resonance spectroscopy
Dikoma Shungu, Ph.D., Departments of Radiology, Neurology and Neuroscience, Weill Cornell Medicine

A re-examination of the cognitive behavioral theory of CFS
Madison Sunnquist, DePaul University

Potential for an immunosignature assay to aid in classification and prediction of rituximab response in ME/CFS
David Patrick, M.D., FRCPC, MHSc, University of British Columbia School of Population and Public Health

12:15 pm – 1:45 pm
Lunch Break/Visit Exhibitors

Special Lunch Session: ME/CFS studies at the Centers for Disease Control and Prevention
Multi-site Clinic Assessment of ME/CFS (MCAM)
Chair: Elizabeth R. Unger, M.D., Ph.D.
Chief, Chronic Viral Diseases Branch
Centers for Disease Control and Prevention (CDC)

Study design of the multi-site clinic assessment of ME/CFS (MCAM)
Elizabeth R. Unger, M.D., Ph.D.
Jin-Mann S. Lin, Ph.D., Senior statistician/epidemiologist, US Centers for Disease Control and Prevention

Description of the Multi-site Clinic Assessment of ME/CFS (MCAM) Study
Mangalathu Rajeevan, Ph.D., Research Microbiologist, US Centers for Disease Control and Prevention

Data on cognitive function from Multi-Site Clinical Assessment of Myalgic Encephomyelitis/Chronic Fatigue Syndrome (MCAM) – Preliminary Analysis
Gudrun Lange, Ph.D., Consulting Clinical Neuropsychologist, Mount Sinai Beth Israel Pain and Fatigue Study Center.

Exercise testing data from the Multi-Site Clinic Assessment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (MCAM) Study
Dane Cook, Ph.D., Professor ofKinesiology, University of Wisconsin-Madison

Salivary test data from the Multi-site Clinic Assessment of Myalgic Encephomyelitis/Chronic Fatigue Syndrome (ME/CFS) (MCAM) Study
Jin-Mann S. Lin, Ph.D., Senior statistician/epidemiologist, US Centers for Disease Control and Prevention

Pilot study evaluating impact of sample processing and assay format on measured natural killer cell function
Troy Querec, Ph.D., Associate Service Fellow, Associate Service Fellow

1:45 pm – 2:45 pm
Session 3: Gulf War Illness
Session Co-chairs:
Kristy Lidie, Ph.D., US Department of Defense
Victor Kalisinsky, Ph.D., US Department of Veterans Affairs
Gulf War Illness Program Officers

Gulf war illness and chronic fatigue syndrome: lessons learned
Presenter: Lea Steele, Ph.D., Research professor, Baylor University Institute of Biomedical Studies

Brain Immune Interactions in Gulf War Illness: Cytokines and Cognition in US Military Veterans
Kimberly Sullivan, Ph.D., Boston University Medical Campus

Genomic approach to find mechanisms of Gulf War Illness pathobiology
Lubov Nathanson, Ph.D., Institute for Neuro Immune Medicine, Nova Southeastern University

Using gene expression signatures to identify novel treatment strategies in Gulf War Illness
Travis Craddock, Ph.D., Department of Psychology & Neuroscience, Nova Southeastern University

2:45 pm – 3:15pm
Break/Visit Exhibits

3:15 pm – 5:15 pm
Session 4: Diagnosing CFS/ME; Difficult Clinical Cases: Focus on Fatigue and Pain
Session Chair: Nancy Klimas, M.D.
Immediate Past President, IACFS/ME
Professor of Medicine & Director, Nova Southeastern University
Director, Miami VAMC Gulf War Illness & ME/CFS Research Program

Panel:
Lucinda Bateman, M.D., Bateman Horne Center of Excellence, Utah
John Chia, M.D., UCLA School of Medicine
Charles Lapp, M.D., Hunter-Hopkins Center, North Carolina
Dan Peterson, M.D., Sierra Internal Medicine, Incline Village, Nevada
Katherine Rowe, M.D., Royal Children's Hospital , Australia
Peter Rowe, M.D., Johns Hopkins University School of Medicine

5:15 pm – 6:00 pm
Visit Poster Presentations/Exhibits

Evening Session
6:30 pm – 8:30 pm
Common Data Elements (CDEs) for Standardized Testing and Clinical Studies
Chair: Vicky Whittemore, Ph.D.
Program Director, Channels, Synapses and Circuits
National Institute of Neurological Disorders and Stroke

The National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health and the Center for Disease Control and Prevention (CDC) will partner to develop common data elements (CDEs) for standardized testing and common data elements to be recorded in clinical studies/trials of individuals with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The development of CDEs for ME/CFS will facilitate the comparison of results across studies and help to standardize analysis. The session will be led by NINDS and CDC Program Staff to discuss the timeline and process for developing the CDEs and to obtain feedback and input from ME/CFS stakeholders.


General Session Agenda-Saturday, October 29th

8:00 am – 9:00 am
Session 5: CFS, SEID, ME Case Definitions: Clinical vs. Research Criteria
Presenter: Leonard Jason, Ph.D.
Professor, DePaul University, Director of the Center for Community Research

Discussants:
Lucinda Bateman, M.D.
Chief Medical Officer
Bateman Horne Center of Excellence
Salt Lake City, Utah

Jon Kaiser, M.D.
IACFS/ME Board Member
University of California, San Francisco

9:00 am – 10:00 am
Session 6: Symptom Provocation Studies I
Chair: Staci Stevens, M.A.
Founder, WorkWell Foundation

Cardiopulmonary exercise testing demonstrates post-exertional chronotropic incompetence
Mark Van Ness, Department of Health, Exercise, and Sport Science, University of the Pacific

Post-exertional malaise: multiple and unexpected symptoms, sometimes delayed, often prolonged
Lily Chu, M.D., Stanford University School of Medicine

Cognitive function in adolescents with chronic fatigue syndrome/myalgic encephalomyelitis:
A novel paradigm
Sarah Knight, Ph.D., Murdoch Children’s Research Institute, Australia

10:00 am – 10:30 am
Break/Visit Exhibits

10:30 am – 12:00 pm
Session 7: Public Health Research
Chair: Steve Krafchick, MPH, JD
IACFS/ME Board Member

Estimating rates of pediatric chronic fatigue syndrome and myalgic encephalomyelitis in a community-based sample
Leonard A. Jason, Ph.D., DePaul University

Two year follow-up of impaired range of motion in adolescent chronic fatigue syndrome
Peter C. Rowe, M.D., Johns Hopkins University School of Medicine

Allergic disorder phenotypes in ME/CFS and patterns of medical comorbidity and clinical dysfunction
Susan Levine, M.D., Cornell Medical Center, New York City

Exploring the role of sex hormones in driving symptom severity in ME/CFS
Gordon Broderick, Ph.D., Department of Medicine, University of Alberta

Nurses’ acute fatigue predicts sickness absence in the workplace: a 1-year retrospective cohort study
Knar Sagherian, RN, MSN, University of Maryland School of Nursing

Examining the accuracy of a physical diagnostic technique for chronic fatigue syndrome/myalgic encephalomyelitis: a blind controlled study
Ray Perrin, DO, Ph.D., Honorary Senior Lecturer: Allied Health Professions Research Unit, University of Central Lancashire, UK


12:00 pm – 1:30 pm
Lunch Break/Visit Exhibits

Lunch Panel
Special Interest Groups: International Research Networks
David Patrick, Ph.D., Moderator
Professor and Director
School of Population and Public Health
University of British Columbia, Canada

European network on myalgic encephalomyelitis/chronic fatigue syndrome (EUROMENE)
Eliana Lacerda, M.D., Ph.D., Assistant Professor, London School of Hygiene & Tropical Medicine

The case for stratification in ME/CFS: Experience from the UK ME/CFS Biobank
Luis Nacul, M.D., Ph.D.
London School of Hygiene & Tropical Medicine

1:30 pm – 2:30 pm
Session 8: Research on Autonomic Functioning and Comorbidities
Chair: Peter Rowe, M.D., Johns Hopkins University School of Medicine

Postural tachycardia in chronic fatigue syndrome induced by exercise
Madison Keefe, B.S., Georgetown University

Distribution of dolorimetry in CFS, FM, GWI and control women
Amber Surian, M.S., Department of Medicine, Georgetown University

Truncal ataxia is an unrecognized cause of orthostatic intolerance in patients with myalgic encephalomyelitis
Kunihisa Miwa, M.D.
Miwa Naika Clinic, Japan

2:30 pm – 3:30 pm
Session 9: Advances in Brain Research and Neurological Studies
Chair: Anthony L. Komaroff, M.D., Professor of Medicine, Harvard Medical School (retired)

Assessment of neurobiological dysfunction in chronic fatigue syndrome
Ben Natelson, M.D.
Pain & Fatigue Study Center, Mount Sinai Beth Israel

Disrupted functional connectivity in Gulf War illness (GWI)
James N. Baraniuk, M.D., Department of Medicine, Georgetown University

Functional neural consequences of post-exertion malaise in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)
Dane B. Cook, Ph.D., University of Wisconsin-Madison

3:30 pm – 4:00 pm
Break/Visit Exhibits

4:00 pm – 5:00 pm
Visit Poster Presentations/Exhibits

5:00 pm – 6:00 pm
IACFS/ME Membership Business Meeting

6:00 pm – 7:00 pm
IACFS/ME Social/Cocktails Hour

7:00 pm – 8:00 pm
IACFS/ME Banquet Dinner

8:00 pm – 9:00 pm
Awards Presentation


General Session Agenda-Sunday, October 30th

8:00 am – 9:15 am
Session 10: Symptom Provocation Studies II
Chair: Betsy Keller, Ph.D.
Department of Exercise and Sport Sciences, Ithaca College

Blood lactate increases more rapidly after a previous exercise challenge in patients with chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) than in healthy subjects
Katarina Lien, M.D., Ph.D., University of Oslo

Subsets of ME/CFS patient responses to a 2-day CPET
Betsy Keller, Ph.D., Department of Exercise and Sport Sciences, Ithaca College

Neuromuscular Strain Increases Symptom Intensity in Chronic Fatigue Syndrome
Peter Rowe, M.D, Johns Hopkins University School of Medicine

Polar Metabolites Distinguish ME/CFS Patients and Controls
Maureen Hanson, Ph.D., Department of Molecular Biology and Genetics, Cornell University

9:15 am – 10:30 am
Session 11: Genetics Research
Chair: Jose Montoya, M.D.
Professor of Medicine, Stanford University Medical Center

Single nucleotide polymorphisms in myalgic encephalomyelitis: possible genetic factors influencing pathophysiology
Benjamin Eike, B.A., Nova Southeastern University, College of Osteopathic Medicine

Using gene expression modules to identify gender specific treatments in myalgic encephalomyelitis/chronic fatigue syndrome
Mary G. Jeffery, Institute for Neuro-Immune Medicine, Nova Southeastern University

Epigenetic modifications and glucocorticoid sensitivity in myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)
Wilfred de Vega, Ph.D. Can.
University of Toronto

ME/CFS miRNA analysis, mRNA in-situ hybridization and STAT1 localization upon stress trigger
Paula A. F. Waziry, Ph.D., Institute of Neuro Immune Medicine, Nova Southeastern University

Genomics of chronic fatigue syndrome reveals systemic inflammatory response
Jose G. Montoya. M.D., Stanford University School of Medicine

10:30 am – 10:45 am
Break

10:45 am – 12:15 pm
Session 12: Panel Discussion
“Nothing about us without us:” How community-engaged research can accelerate progress in the field of ME/CFS
Moderator: Lily Chu, M.D., MSHS, Co-Vice President, IACFS/ME; Collaborator, Stanford ME/CFS Initiative

Speaker: William Elwood, Ph.D., Expert, community-engaged research, US National Institutes of Health (NIH) Member, Trans-NIH Working Group for ME/CFS

Panelists
Jin-Mann Lin, Ph.D., Senior statistician/epidemiologist, US Centers for Disease Control and Prevention
Leonard Jason, Ph.D., Professor of community psychology, DePaul University (Chicago, Illinois)
Sonya Chowdhury, Chief Executive, Action for M.E.; Member, United Kingdom ME/CFS Research Collaborative
Jennifer Spotila, J.D., FDA Patient Representative; former chairman, Solve ME/CFS Initiative Board of Directors

12:15 pm – 1:15 pm
Lunch/Visit Exhibits
Networking Lunch - Offering an opportunity for clinicians to network and talk about assessment and treatment issues.

1:15 pm – 2:30 pm
Session 13: Medical Education Proposals for ME/CFS
Panel Chair: Susan Levine, M.D., Visiting Fellow, Cornell University, Ithaca, NY

Fellowship program for CFS/ME research (I)
Mady Hornig, M.D., Columbia University Medical Center

A fellowship training program for ME/CFS (II)
Anthony Komaroff, M.D., Harvard Medical School (retired)

Fellowship opportunity in ME/CFS (III)
Daniel Peterson, M.D., Simmaron Research

2:30 pm – 3:00 pm
Summary of the Conference
Anthony L. Komaroff, M.D.

3:00pm
Conference Concludes
 

Ron

Member
Patient's Agenda:
12th International IACFS/ME Joint Patient and Professional Conference

Thursday, October 27th

8:00 am – 8:10 am
Welcome & Introduction

Fred Friedberg, Ph.D.
President, IACFS/ME
Research Associate Professor, Stony Brook University
Founder and Editor, Fatigue: Biomedicine, Health, and Behavior

8:10 am – 8:20 am TBA

8:20 am – 9:15 am (last 15 min.: Q and A)
New ME/CFS Developments at the National Institutes of Health
Keynote Speaker: Vicky Whittemore, Ph.D.
Program Director, Channels, Synapses and Circuits
National Institute of Neurological Disorders and Stroke

9:15 am – 10:00 am (last 15 min.: Q and A)
Rituximab and Emerging Treatments
Daniel Peterson, M.D.
Sierra Internal Medicine
Oystein Fluge, MD
Chief Physician, Department of Oncology,
Haukeland University Hospital, University of Bergen, Norway
Olav Mella, MD
Department director/professor, Haukeland University Hospital, Oslo, Norway

10:00 am – 10:30 am
Break/Visit Exhibits


10:30 am – 11:15 am (last 15 min.: Q and A)
Ensuring effective and efficient medical appointments: What can patients and caregivers do?
Lily Chu, M.D.
Independent Consultant
Co-Vice President, IACFS/ME

11:15 am – 11:45 am (last 10 min.: Q and A)
If not opioids, then what?
Jarred Younger, Ph.D.
Associate Professor
University of Alabama at Birmingham

11:45 am – 1:15 pm
Lunch Break/Visit Exhibits
Advocacy Roundtable

1:15 pm – 3:00 pm
Patient workshops (run concurrently; attendees select one only)

Legal Issues with ME/CFS--Myths and Reality (Joint Patient and Professional Workshop)
Steven Krafchick, J.D., M.P.H.
Krafchick Law Firm
IACFS/ME Board Member

Educating students suffering from ME/CFS—a Global Perspective (Joint Patient and Professional Workshop)
Faith Newton, Ed.D.
Associate Professor of Education
Delaware State University

Moving ME/CFS Forward Internationally (Joint Patient and Professional Workshop)
Margaret Parlor
President, National ME/FM Action Network (Canada)
Mary Dimmock, Advocate and Author

Music, Meditation, and Movement (Patient Workshop)
Judy-Anne Wilson
Educator and artist
Treasurer, ME Society of Edmonton, Canada

Pacing Approaches, Healing Time, and Other Techniques to Help Lessen ME/CFS Symptoms (Patient Workshop)
Jon Kaiser, M.D.
University of California, San Francisco

4:00 pm – 5:00 pm (last 15 min. Q and A)
Fibromyalgia Update
Lucinda Bateman, M.D.
Fatigue Consultation Clinic
Jarred Younger, Ph.D.
Associate Professor
University of Alabama at Birmingham
Following each talk, speakers will field questions written on cards by the audience as time permits

Evening sessions TBA
 

laureano

Member
Ok so this is Anita and I just wanted to jump in and say that the news of approval in Argentina is very good for us ALL of us because it is the first drug approved for ME/CFS. The science and research has progressed immensely in the 19 years that I have taken Ampligen. It has significantly helped me!

My labs have gone back to normal and I'm able to do much more than before, meaning upright and off the sofa v bedridden with fevers and swollen glands. it is an immune modulator and makes your body produce interferon and eradicates the reactivated viruses in the blood and spinal fluid. and acts as a high powered anti-inflammatory agent so the brain swelling of encephalitis has gone down - meaning I also have less headaches as well as more energy and ability to fight infection. talk about risk v. Benefit!

I have no side affects but highly improved health. I wish for every patient to get medicine!

It hurts my heart to see patients suffering when there is a medicine out there that can help a certain subset. Slso, this approval makes it easier for other new drugs to be invented that might help even more because the press alone has inspired more scientists to come on board and search for answers.
I'm from Argentina, I hope I can start taking this as soon as it becomes available on the market...
 

Cort

Founder of Health Rising and Phoenix Rising
Staff member
Argentina! Cool - Let us know how it goes....if you can get it easily enough, how much it costs and how it goes.

Good luck!
I'm from Argentina, I hope I can start taking this as soon as it becomes available on the market...
 

jsuzor

Member
I know of four people who have improved. Anita Patton is one - her recovery story is in the recovery stories section. I've met her several times. Bob Miller was still pretty impaired but he was able to function and travel and without it he was basically bedridden. He was on it for years and may still be on it. He tried to go off and relapsed after a year or two. Mary Schweitzer's case is well dooumented as well. She's given testimony at many CFSAC meetings. I saw her off Ampligen - she was in a wheelchair and could hardly talk and then there's Kelvin Lord - he published a long and really hilarious series of blogs of his experiences when I was Phoenix Rising...He was desperate when he went on it and was functioning and working again but certainly not cured on the drug.

I also know of people who got absolutely no help at all on the drug.

There's no doubt Hemispherx has a really tattered past and there's a blog on that in the Resource section below. I hope that is all behind them.
I know of four people who have improved. Anita Patton is one - her recovery story is in the recovery stories section. I've met her several times. Bob Miller was still pretty impaired but he was able to function and travel and without it he was basically bedridden. He was on it for years and may still be on it. He tried to go off and relapsed after a year or two. Mary Schweitzer's case is well dooumented as well. She's given testimony at many CFSAC meetings. I saw her off Ampligen - she was in a wheelchair and could hardly talk and then there's Kelvin Lord - he published a long and really hilarious series of blogs of his experiences when I was Phoenix Rising...He was desperate when he went on it and was functioning and working again but certainly not cured on the drug.

I also know of people who got absolutely no help at all on the drug.

There's no doubt Hemispherx has a really tattered past and there's a blog on that in the Resource section below. I hope that is all behind them.
 

jsuzor

Member
Okay, I have a lot to learn on the subject of Ampligen. I am impressed that there are 4 or more people who have gotten good results!
 

glori h

Member
Ampligen became the first drug approved for chronic fatigue syndrome (ME/CFS) anywhere in the world this week when ANMAT, the Argentine FDA, approved the drug for use in people with severe ME/CFS. Why should we get excited about Ampligen's approval in Argentina? Because Argentina has a modern medical system which includes having a rigorous drug approval process. Hopefully this will be a harbinger of things to come for Ampligen.

[fright]View attachment 1948 [/fright]Argentina was the first Latin American country Hemispherx Biopharma (HB) - the maker of the drug - tried to get Ampligen approval in. The process, which took four years, began when HB teamed up with GP Pharm, an Argentine pharmaceutical company. GP Pharm used the same studies to shepherd the approval through ANMAT, the Argentine form of the FDA, that HB used in its FDA application for Ampligen two years ago.

Ampligen was approved for use in people with "severe ME/CFS" - a designation that was based on the type of ME/CFS patients that took part in the company's original U.S. studies. A person with severe ME/CFS in Argentina needs to meet the new IOM and the (old) Holmes criteria, and have a Karnovsky score between 40 and 60 in order to get access to the drug.
  • 40: Disabled; requires special care and assistance.
  • 50: Requires considerable assistance and frequent medical care.
  • 60: Requires occasional assistance, but is able to care for most of his personal needs.
Hemispherx believes that at least 100,000 and perhaps as many as 500,000 patients in the 42 million person country will meet the criteria.

Equel's has been making the rounds of media outlets to discuss Ampligen. A financial analyst with Crystal Research agreed in an interview at Small Cap Nation - a financial media outlet focused on small companies - that the potential for Ampligen in the ME/CFS market alone was huge. With Ampligen the sole drug even being considered at this point for ME/CFS it would have the market to itself. He called the Argentine approval "very significant" and put the potential valuation of the drug in the multi-billion dollar range.


He also agreed the Argentine approval will make getting approval elsewhere easier.

The FDA Question

I talked with Nancy McGrory at Hemispherx about the recent approval. She believes the approval could help HB in other countries with similar regulatory drug processes. The fact that Ampligen passed muster in a country with a modern medical system with a rigorous drug approval process will likely, McGrory thought, prompt other countries to take a much closer look at the drug.

Ten years ago, she noted, most pharmaceutical drug companies concentrated on getting drug approval at the FDA first in the belief that making it through the FDA's notoriously tough regulatory process would give other countries confidence that the drug was safe and effective. The FDA - which is focused first on protecting the public health - has proved so risk averse lately, though, that some drug companies are choosing to get drug approval outside the U.S. first.

That brought up the question, though, what's going with FDA approval for Ampligen? When I asked McGrory about the reception Ampligen was getting at the FDA these days, she sounded hopeful. She said she believed that the work of patients, advocates and ME/CFS experts to educate the FDA about ME/CFS had paid off. The FDA Workshop and other meetings, she believed, really got the message across about how serious disease is, and that produced a sea-change in the agencies attitude towards ME/CFS. The FDA she thought, would like very much to approve a drug for this illness.

Thomas Equels, HB's new President has made Ampligen approval the companies top priority and has stated that he will to do whatever is necessary to get it done. McGrory said HB officials have meet with the FDA and the NIH several times, and will soon meet to finalize the protocol for what will hopefully be the final phase III study on ME/CFS.

The FDA wants, and is going to get a several hundred person trial. Equel's job now is to find partners to fund it. The companies new stance - that it’s committed to reach out and either license its technology or find a major pharmaceutical company or investor to assist it - is a distinct change of pace at HB.

In another hopeful note, Hemispherx reported it's at long last identified a subset of high responders to Ampligen and will present a paper to that effect at the IACFS/ME conference in October. Finding high responders to Ampligen would, of course, greatly help HB be successful in a phase III trial.
When asked in an extensive interview with Wall Street Transcript about what a potential investor should know about Ampligen Equels said:


 

glori h

Member
Ampligen became the first drug approved for chronic fatigue syndrome (ME/CFS) anywhere in the world this week when ANMAT, the Argentine FDA, approved the drug for use in people with severe ME/CFS. Why should we get excited about Ampligen's approval in Argentina? Because Argentina has a modern medical system which includes having a rigorous drug approval process. Hopefully this will be a harbinger of things to come for Ampligen.

[fright]View attachment 1948 [/fright]Argentina was the first Latin American country Hemispherx Biopharma (HB) - the maker of the drug - tried to get Ampligen approval in. The process, which took four years, began when HB teamed up with GP Pharm, an Argentine pharmaceutical company. GP Pharm used the same studies to shepherd the approval through ANMAT, the Argentine form of the FDA, that HB used in its FDA application for Ampligen two years ago.

Ampligen was approved for use in people with "severe ME/CFS" - a designation that was based on the type of ME/CFS patients that took part in the company's original U.S. studies. A person with severe ME/CFS in Argentina needs to meet the new IOM and the (old) Holmes criteria, and have a Karnovsky score between 40 and 60 in order to get access to the drug.
  • 40: Disabled; requires special care and assistance.
  • 50: Requires considerable assistance and frequent medical care.
  • 60: Requires occasional assistance, but is able to care for most of his personal needs.
Hemispherx believes that at least 100,000 and perhaps as many as 500,000 patients in the 42 million person country will meet the criteria.

Equel's has been making the rounds of media outlets to discuss Ampligen. A financial analyst with Crystal Research agreed in an interview at Small Cap Nation - a financial media outlet focused on small companies - that the potential for Ampligen in the ME/CFS market alone was huge. With Ampligen the sole drug even being considered at this point for ME/CFS it would have the market to itself. He called the Argentine approval "very significant" and put the potential valuation of the drug in the multi-billion dollar range.


He also agreed the Argentine approval will make getting approval elsewhere easier.

The FDA Question

I talked with Nancy McGrory at Hemispherx about the recent approval. She believes the approval could help HB in other countries with similar regulatory drug processes. The fact that Ampligen passed muster in a country with a modern medical system with a rigorous drug approval process will likely, McGrory thought, prompt other countries to take a much closer look at the drug.

Ten years ago, she noted, most pharmaceutical drug companies concentrated on getting drug approval at the FDA first in the belief that making it through the FDA's notoriously tough regulatory process would give other countries confidence that the drug was safe and effective. The FDA - which is focused first on protecting the public health - has proved so risk averse lately, though, that some drug companies are choosing to get drug approval outside the U.S. first.

That brought up the question, though, what's going with FDA approval for Ampligen? When I asked McGrory about the reception Ampligen was getting at the FDA these days, she sounded hopeful. She said she believed that the work of patients, advocates and ME/CFS experts to educate the FDA about ME/CFS had paid off. The FDA Workshop and other meetings, she believed, really got the message across about how serious disease is, and that produced a sea-change in the agencies attitude towards ME/CFS. The FDA she thought, would like very much to approve a drug for this illness.

Thomas Equels, HB's new President has made Ampligen approval the companies top priority and has stated that he will to do whatever is necessary to get it done. McGrory said HB officials have meet with the FDA and the NIH several times, and will soon meet to finalize the protocol for what will hopefully be the final phase III study on ME/CFS.

The FDA wants, and is going to get a several hundred person trial. Equel's job now is to find partners to fund it. The companies new stance - that it’s committed to reach out and either license its technology or find a major pharmaceutical company or investor to assist it - is a distinct change of pace at HB.

In another hopeful note, Hemispherx reported it's at long last identified a subset of high responders to Ampligen and will present a paper to that effect at the IACFS/ME conference in October. Finding high responders to Ampligen would, of course, greatly help HB be successful in a phase III trial.
When asked in an extensive interview with Wall Street Transcript about what a potential investor should know about Ampligen Equels said:


Annual projected drug cost $41,600 per year?
 

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