Ampligen in europe

[aquariusgirl]

Hemispherx ships Ampligen for European chronic fatigue syndrome program http://bizj.us/1nj572

Anyone know anything about this?

 

[shannah]

A different article reads,

PHILADELPHIA, July 25, 2016 (GLOBE NEWSWIRE)

Hemispherx Biopharma (NYSE MKT:HEB) announced today that the first order of rintatolimod (Ampligen®) for the Early Access Program (EAP) in Europe has been shipped with receipt confirmed on July 22. On May 23, 2016, the Company executed an amended and restated agreement with Impatients N.V., a Netherlands-based company operating as myTomorrows, for the commencement and management of an Early Access Program (EAP) in all of Europe and Turkey. Ampligen® is the trade name in the United States for rintatolimod.

“This program will enable Chronic Fatigue Syndrome (CFS) patients, who face an unmet medical need in the EU, to access rintatolimod under early access regulations,” said Tom Equels, CEO of Hemispherx. “It will operate concurrently while we work with the FDA to determine a path toward approval in the United States. The initiation and implementation of our EAP out-reach is an important tangible step in our effort to make our experimental drug Ampligen® a commercially approved drug available to all those suffering from CFS.”

http://globenewswire.com/news-relea...ss-Program-in-Europe.html?f=22&fvtc=9&fvtv=us

 

[Seven7]

what about US? can we get it here as a EAP?

 

[JohnnyD]

You can get it in the U.S through the AMP511. But it sounds like they are gearing up for a new trial and a new protocol. The company website says: "new protocol in development" ... and today this:

Hemispherx Biopharma Reaches Agreement with Avrio Biopharmaceuticals for the Accelerated Production of Ampligen®

GlobeNewswire•July 27, 2016
Comment
PHILADELPHIA, July 27, 2016 (GLOBE NEWSWIRE) -- Hemispherx Biopharma (NYSE MKT:HEB) ("Hemispherx" or the “Company") announced today that it has reached an agreement with Avrio Biopharmaceuticals (“Avrio”), Irvine California, to serve as an additional contract manufacturer of Hemispherx’s experimental drug, Ampligen®, also known by its generic name rintatolimod. Avrio, an FDA inspected facility, has the capabilities for the compounding and fill/finish of sterile clinical and commercial grade Ampligen® to satisfy the Company’s ongoing domestic clinical studies as well as the recently initiated Early Access Program (EAP) in Europe and Turkey. This agreement with Avrio should allow Hemispherx to rapidly replenish its Ampligen®/rintatolimod inventory. Serving the EAP, outside of the United States, is especially important because it has the potential to generate positive cash flow on EAP transactions while Hemispherx seeks commercial approval for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) in the United States, Argentina, and elsewhere.

Thomas Equels, Hemispherx CEO, commented, “We are pleased to be working with Avrio, a well-respected professional team that is highly motivated to support our short term goal of accelerated manufacturing of Ampligen® to serve our clinical initiatives and the EAP, as well as partner with us for the long haul. Avrio, as an additional CMO for Ampligen®, provides price efficiencies, very rapid turnarounds, and a safety net of redundancy. Maintaining a supply of clinical grade Ampligen® is one of our top priorities since many individuals with severe ME/CFS continue to seek Ampligen® availability through our access programs.”

Dr. Assad Kazeminy, CEO of Avrio Biopharmaceuticals, noted, “The new relationship with Hemispherx represents an exciting addition to our well-established client portfolio. We are delighted with the Hemispherx decision, and strongly believe that Hemispherx’s manufacturing strategy is an excellent match to Avrio’s core competencies.”