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Hemispherx Biopharma Inc. Announces Advancement in Expanded Access Program for Ampligen in the Treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Second Large Shipment Dispatched to Second Major Clinic
OCALA, Fla., Jan. 02, 2019 (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 325 recently manufactured vials of Ampligen to the Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) clinical site at Incline Village, Nevada, run by Daniel Peterson, MD. This clinic is at the forefront of ME/CFS research and treatment. The vials 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 the fight against this quality-of-life impacting disease where there is no commercially approved therapy.
Hemispherx recently announced the expansion of the protocol. New enrollees will not be eligible to participate in a future confirmatory trial. A plan for a future pivotal confirmatory trial is in development, but previously-treated patients will not be eligible for participation. This renders the EAP an increasingly important tool for patients who benefited from Ampligen based on their inclusion in previous trials.
Hemispherx manufactures Ampligen, and it is the Company’s control over the production of the product that allows for use of the product in this EAP. In 2018, the Company produced two large lots, totaling approximately 16,000 vials, replenishing Ampligen supplies.
“More than 100,000 Americans are fully disabled by severe ME/CFS. This is a horrible disease and a totally unmet medical need in the United States. ME/CFS in its most severe form takes people from the workforce and from their family life, leaving them in a bedridden state,” said CEO Thomas K. Equels. “Ampligen is the first and only meaningful therapy approved anywhere in the world for ME/CFS, with our recent approval in Argentina. It is also the only ME/CFS drug with a late stage new drug application at the U.S. Food and Drug Administration. This progress in expanding AMP-511, as we ended the year, is also a message of hope. While we have made great advances in our immuno-oncology programs, we want those suffering from ME/CFS to know that TeamHemispherx will never give up in the fight for therapeutic options in ME/CFS.”
Daniel Peterson, MD, a world-renowned expert in the treatment of ME/CFS with Ampligen and principal investigator at the Incline Village Nevada clinic states, “Rintatolimod, or Ampligen, is a useful drug for a subset of severely ill ME/CFS patients to improve quality of life and functional status. In some cases, the response can be so dramatic that patients return to gainful employment and/or school following treatment. Rintatolimod has an excellent safety profile. In addition, there are measurable outcomes to assess the drug’s efficacy, which should be investigated.”
The FDA authorizedexpanded 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 in the final stages of identifying 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