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Hemispherx Biopharma Inc. Announces First Large Ampligen Shipment to a Clinical Site for Use in U.S. Expanded Access Program
OCALA, Fla., Dec. 19, 2018 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE American: 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 (”EAP”) known as “AMP-511”. The FDA authorized the AMP-511 protocol to treat ME/CFS patients in an effort to expand compassionate care in this dread disease which is estimated to disable more than 100,000 Americans.
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.”
The FDA authorized expanded access program will allow treatment of up to 100 ME/CFS patients at any one time at approved clinical infusion therapy sites. Ampligen has received approval from Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica (“ANMAT”) for commercial sale of Ampligen in the Argentine Republic for the treatment of severe ME/CFS. Details of the commercial launch are in the final stages in Argentina. Further, Ampligen has completed a U.S. based Phase III study for the treatment of ME/CFS, and the Company is working to develop a subset of high level Ampligen responders for consideration by the FDA in a confirmatory trial to help complete our pending New Drug Application with the FDA. The first steps for initiating our European EAP in ME/CFS are now underway. In oncology, Ampligen is an experimental drug currently undergoing clinical Phase I/II development for the treatment of certain cancers at major U.S. cancer research centers based on successful animal studies. Further, the Dutch government has approved an EAP for late stage pancreatic cancer patients, which has been underway with full reimbursement for over one year.
Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. Among other things, for those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.hemispherx.net. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
Hemispherx Biopharma, Inc.
LHA Investor Relations
Miriam Weber Miller
Senior Vice President