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Hemispherx to Distribute Second Lot of Ampligen® for use in Multiple Indications in Argentina, the United States and Europe
Ampligen supply will support product launch in Argentina, Expanded Access Programs for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome in the United States and Europe and pancreatic cancer in the Netherlands, and upcoming U.S. based Phase I/II combination therapy clinical trials in various solid tumors
ORLANDO, Fla., Sept. 18, 2018 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE American: HEB) announced today regulatory inspection and clearance for distribution of the Company's second commercial scale lot of Ampligen® (rintatolimod), which is slated for multiple uses including product launch in Argentina, where Ampligen is approved for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), ME/CFS expanded access program (EAP) in the United States and Europe and an EAP in the Netherlands for pancreatic cancer. This lot includes approximately 8,000 vials and is the second such lot filled and finished this year, giving a usable Ampligen supply of approximately 16,000 vials.
Ampligen, a first-in-class drug of large macromolecular RNA (ribonucleic acid) molecules, was approved for commercial sale in Argentina in 2016 for the treatment of ME/CFS, the first therapy ever approved for this quality-of-life impacting disease. The Argentine commercial launch is scheduled for year end and the first quarter of 2019. The Company will also provide Ampligen to medical centers in the U.S. and Europe for use in EAPs for patients with ME/CFS and in the Netherlands for pancreatic cancer. Finally, but significantly, the Company expects to commence additional clinical trials using Ampligen in combination with FDA-approved checkpoint blockade therapies in an effort to improve overall efficacy and survival in cancers such as pancreatic, non-small cell lung, ovarian and colorectal tumors, the first of which may commence within sixty days.
"We are pleased to announce completion of our second commercial size lot of Ampligen and excited about the opportunities availability of the therapy affords us. From a product launch in Argentina, to supporting patients through EAPs and in evaluation for the treatment of solid tumors, we are working to advance Ampligen as rapidly as possible, and realize its potential across multiple market opportunities," said Thomas K. Equels, Chief Executive Officer of Hemispherx. "While there are millions of ME/CFS patients across the globe, the approval of Ampligen in Argentina represents the first therapy ever approved for treatment of the condition. Additionally, we are hopeful that our initial trials in solid tumor indications will demonstrate the promise of the therapy in combination with checkpoint inhibitors and have a true impact on the cancer treatment paradigm."
I’m not sure what this means...anything that treats this will likely have a lot of side effects...just like RA and MS meds. About 25 % improve on Ampligen.
@prioristhe side effects and "improve" percentage should be red flags for you
people drinking too much from the conventional medical system of pharma and surgery well will shorten their life span
Thank you for your posts. I’m sorry that you have been sick for nearly your entire life. I can only imagine how much you have researched and how many treatments you have tried.
I’d like to hear more about your experiences with Ampligen and Hemespherx if you don’t mind sharing.
A press release:
AIM doses first ‘long hauler’ patient in trial of post-Covid-19 infection
Where does one obtain treatment with Ampligen? Is it available in Argentina now?
Has anyone enquired about getting Ampligen in/ from Argentina?