FDA declines to approve Hemispherx's Ampligen new drug application

[Sasha]

BTW, Bob has ended his hunger strike, is fine - I'm starting a new thread on that.

Big relief to all of us, I suspect.

 

[dannybex]

Kati and Barb: Well, I guess I understand, especially Kati, considering your mom's situation, and Barb, who comes from a nursing background (?). Very sorry about your mom Kati.

At the same time you're both reading far too much into what I asked or said (coffee enemas?!). I'm not saying drugs are out of the question, or never necessary, but to ignore the methylation issues (found in almost every CFS patient so far), how carnitine helps with mitochondrial issues, omega 3's help with circulation and inflammation, etc. not to mention ignoring the obvious changes in what we eat compared to 50-60 years ago...well, I guess we'll have to agree to disagree, and wish each other well.

And Sasha -- that's great to hear about Bob. I'm amazed he survived, and glad to hear he's eating again.

 

[barbc56]

Kati and Barb: Well, I guess I understand, especially Kati, considering your mom's situation, and Barb, who comes from a nursing background (?). Very sorry about your mom Kati.

At the same time you're both reading far too much into what I asked or said (coffee enemas?!). I'm not saying drugs are out of the question, or never necessary, but to ignore the methylation issues (found in almost every CFS patient so far), how carnitine helps with mitochondrial issues, omega 3's help with circulation and inflammation, etc. not to mention ignoring the obvious changes in what we eat compared to 50-60 years ago...well, I guess we'll have to agree to disagree, and wish each other well.

And Sasha -- that's great to hear about Bob. I'm amazed he survived, and glad to hear he's eating again.

I think there are many people on these threads who are doing this.

 

[Kati]

I'm eating fish probably 3 times a week. Wild salmon, sometimes cod. And meat.

Methylation problems have not been brought up to me by the experts I have seen. COQ 10 and carnitine have not been helpful to me and they are both expensive. i refuse to experiment and reading about people's experiments here, I do not feel any comfort in their safety. Moreover, I personally find that other patients and sometimes non-patients recommendations sounds more like medical advice and it can be unsafe. That's my opinion. So I do not visit these threads.

It's just not my cup of tea.

 

[Firestormm]

Hemispherx Biopharma Announces Financial Results for the Three Months Ended June 30, 2013

PHILADELPHIA, Aug. 9, 2013 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE:HEB) announced its financial results for the three months ended June 30, 2013. The net loss (including non-cash effects) was approximately $4,283,000 or $(0.03) per share as compared to a net loss of $3,000,000 or ($0.02) per share for the same three month period in 2012. This Quarter-to-Quarter increase in net loss of approximately $1,283,000 was predominantly caused by:

• a non-cash write-down of existing Alferon N Injection® work in process inventory for $458,000; and
  
• an increase of approximately $470,000 related to continued efforts to seek regulatory approval (U.S.A. and abroad) of the Ampligen® NDA for Chronic Fatigue Syndrome including costs related to clinical studies, research, raw material production and various GMP validation procedures at our New Brunswick, NJ facility.

Read more... linked in title above.

 

[Sparrowhawk]

I'm coming late to this discussion but I didn't see and answer to this question on page one:

"Without approval could doctors still prescribe off-label? I'm assuming this is unlikely as the drug is so expensive (can't help thinking that's at the root of the refusal; neither insurers nor the vastly cut budget of Medicaid want to pay)."

Is the Ampligen trial still going on in NC, self pay?

 

[JohnnyD]

Drugs must be approved in order to be prescribed off-label. Ampligen is experimental. Ampligen for CFS is available only through the AMP 511 Cost Recovery Trial. Presumably, if Ampligen were approved, the cost would come down due to economy of scale. Blue Cross Blue Shield has had Ampligen listed, for some time, as a drug they would cover/pay for (permission needed in advance) when approved.

I don't know for sure -- but I think Dr. Peterson is currently the only doc administering Ampligen. The reason I say this is that he had a recent interview (see ME/CFS Alert) where he stated he currently had 28 patients on Ampligen. Hemispherx 10-Q, released last Friday listed 28 patients currently on Ampligen.

 

[Nielk]

I think there are a few doctors providing Ampligen. Dr. Enlander is one in New York.

 

[vli]

Nielk, my thoughts exactly!!! I don't believe Mary Schweitzer has stopped getting ampligen from him??!

 

[JohnnyD]

Here are the 5 authorized 511 centers. They are all listed as recruiting patients (in clinicaltrials.gov), but I suppose the only way to know for sure, what kind of patient load they have and if they are indeed recruiting, is to call or email them.

Locations
United States, Florida
Nova Southeastern University Chronic Fatigue Center Recruiting
Miami, Florida, United States, 33176
Contact: Ernesto Martinez Duarte 305-595-4300 emartinezduarte@nova.edu
Principal Investigator: Nancy Klimas, MD
United States, Nevada
Dr. Daniel Peterson Recruiting
Incline Village, Nevada, United States, 89451
Contact: Kathleen Colley 775-832-0989 kathleen@ishere.com
Principal Investigator: Daniel Peterson, MD
United States, New York
Dr. Derek Enlander Recruiting
New York, New York, United States, 10065
Contact: Laura Melilli 212-794-2000 enlandercfs@yahoo.com
Principal Investigator: Derek Enlander, MD
United States, North Carolina
Hunter-Hopkins Center, PA Recruiting
Charlotte, North Carolina, United States, 28210
Contact: Wendy Springs 704-543-9692 wendy@drlapp.net
Principal Investigator: Charles Lapp, MD
United States, Utah
The Fatigue Consultation Clinic Recruiting
Salt Lake City, Utah, United States, 84102
Contact: Ali Allen ali@fcclinic.com
Principal Investigator: Lucinda Bateman, MD

 

[vli]

I'm sure the above list is accurate.

 

[Bob]

Here's some limited information about a phase III trial of Ampligen for CFS in a press release from Hemispherx:
http://online.wsj.com/article/PR-CO-20140319-906721.html

PRESS RELEASE
March 19, 2014

Hemispherx Biopharma, Inc. to Present Clinical Interpretations on CFS Treatment at the 11th Biennial International Research and Clinical Conference

Hemispherx Biopharma, Inc. to Present Clinical Interpretations on CFS Treatment at the 11th Biennial International Research and Clinical Conference

PHILADELPHIA, March 19, 2014 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE MKT:HEB) will participate in the 11th Biennial International Research and Clinical Conference to be held in San Francisco, California, USA, March 20-23, 2014. The title of the presentation is "Differential Exercise Responses to Rintatolimod [Ampligen(R)] Exhibited by Patients with Severe Chronic Fatigue Syndrome (CFS)". This Phase III prospective, double-blind, randomized, placebo-controlled trial was conducted at twelve centers by leading researchers in fatigue and post-exertional fatigue.
...
http://online.wsj.com/article/PR-CO-20140319-906721.html

Perhaps it relates to this:
Study of Ampligen in Chronic Fatigue Syndrome
http://clinicaltrials.gov/show/NCT00215813
http://forums.phoenixrising.me/inde...f-ampligen-in-chronic-fatigue-syndrome.23007/

 

[JohnnyD]

There is a followup PR released today. I think what Hemispherx is trying to do here, is present/promote a new endpoint. that is, if a new study is required.


PHILADELPHIA, March 24, 2014 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE MKT:HEB) participated in the 11th Biennial International Research and Clinical Conference held in San Francisco, California, USA, on March 20-23, 2014. The title of the presentation was "Differential Exercise Responses to Rintatolimod [Ampligen(R)] Exhibited by Patients with Severe Chronic Fatigue Syndrome (CFS)". This Phase III prospective, double-blind, randomized, placebo-controlled trial was conducted at twelve centers by leading researchers in fatigue and post-exertional fatigue.

The data on the experimental immunotherapeutic included a re-examination post-hoc of the primary and secondary endpoints as a function of dichotomization of patient responses.

Dichotomization of improvement in exercise performance from baseline at the >=25% and >=50% levels were analyzed on the Intent-to-Treat (ITT) Population. For the ITT population a significantly greater percentage of rintatolimod patients (39%) vs. placebo patients (23%) improved ET (exercise tolerance) duration by >=25% (p=0.013) while 26% compared to 14% of rintatolimod vs. placebo patients, respectively, improved ET duration by >=50% (p=0.028). A frequency distribution analysis of >=25% improvement, =25% worsening in ET from baseline at 40 weeks for the baseline >9 minutes cohort showed net improvement to be 18.3% for the rintatolimod cohort vs. 4.6% deterioration for placebo (p=0.015). A continuous responder analysis using 5% increments from >=25% to >=50% provided a robust clinical enhancement in ET effect in the rintatolimod cohort for the ITT population, as well as, for a subset of patients with baseline ET duration >9 minutes as compared to placebo. The Karnofsky Performance Score (KPS) and Vitality (SF-36 subscale) quality of life secondary endpoints demonstrated similar clinically significant improvements for the rintatolimod cohort as a function of the same ET dichotomization. Rintatolimod was generally well-tolerated in this CFS/ME population.

http://finance.yahoo.com/news/hemispherx-biopharma-inc-presented-clinical-123000373.html