Hemispherx Biopharma Announces First Large Ampligen Shipment to a Clinical Site

Hemispherx Biopharma (NYSE:HEB), an immuno-pharma R&D and emerging commercial growth company focused on unmet medical needs in immunology, shipped 720 vials of Ampligen to the Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) clinical site at Hunter-Hopkins Center in Charlotte, N.C., where it will be used in the Expanded Access Program known as “AMP-511”.

As quoted in the press release:

Hemispherx recently announced the expansion of the protocol, allowing new enrollees, who would not be eligible to participate in a future confirmatory trial. Hemispherx continues to believe that this study does not and will not interfere with any future studies planned to obtain marketing approval. Any future confirmatory clinical trial is not expected to include previously-treated patients such as those currently enrolled in the AMP-511 protocol, and we do not believe that recruitment of new patients into any future studies will be impaired by additional enrollment in the treatment protocol. Expansion was possible because this year Hemispherx successfully produced two commercial-sized lots of Ampligen, which were filled and finished into approximately 16,000 vials. Both lots have passed all necessary release testing and are now available for distribution.

“Tens of thousands of Americans are fully disabled by severe ME/CFS, a horrible disease which takes people from the work force and from their family life, leaving them in a bedridden state almost as incapacitating as paralysis in the most severe cases.” said CEO Thomas K. Equels.  “Our production of new vials of Ampligen and our expansion of the American EAP to new patients is being done with the highest motives of compassionate care. As we enter this holiday season, we at Hemispherx are working to bring hope to a patient population where this severe unmet medical need leaves so many without hope. It is heartbreaking that some patients with this horrible disease — because they cannot see a light at the end of this tunnel — choose suicide rather than a life of endless pain, incapacity, and immobility. According to The Lancet, suicide risk in patients with severe CFS may be increased nearly 700 percent. Our team at Hemispherx is gratified to be able to make the newly produced Ampligen vials available to patients with this condition. Hemispherx is the only company with a late stage drug candidate for ME/CFS therapy in the U.S.”

Click here to read the full press release.