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Hemispherx Biopharma Inc. Announces Updated Information about ME/CFS Expanded Access Program in the United States
Highlights Include Visit with Patients in North Carolina
OCALA, Fla., Dec. 17, 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, recently met with clinical patients at Hunter-Hopkins Center in Charlotte, N.C. undergoing treatment for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS).
Herbert Cousins, SVP for Patient Relations, and Peter Rodino III, Director of Governmental Relations, spoke with patients and the clinician about the company’s progress in expanding its U.S. Treatment Protocol/Expanded Access Program for ME/CFS, known as AMP-511. Cousins was recently hired to manage the company’s communications with patients and patient advocacy groups.
Hemispherx announced the expansion of the program in June — allowing new enrollees for the first time in more than a year — after completing its first commercial-sized lot of its pipeline drug Ampligen, producing ~8,500 vials. A second commercial-sized lot was completed in July. Both lots passed release testing.
“The patients were very happy to talk to us in person about the ME/CFS protocol under AMP-511,” said Cousins. “Together with Dr. Charles Lapp, the investigator at the Hunter-Hopkins site and his team, we answered all of their questions.”
“ME/CFS is a crippling disease that leaves people unable to live their normal lives due to the pain, fatigue and inability to focus that comes when performing even basic tasks. Many are so severely afflicted that they’re forced to live their lives bedridden, imprisoned in darkness and despair without any hope for a better future. More than one hundred thousand Americans are estimated to be totally disabled by the severe form of ME/CFS,” said CEO Thomas K. Equels. “This is why at Team Hemispherx we are totally committed to making an effective and approved therapy available to patients in the United States. Our recent progress in obtaining a commercial approval for severe ME/CFS from the Republic of Argentina, our expansion of the FDA-authorized compassionate care program (AMP-511) in the U.S. and the opening of our first Early Access Program for ME/CFS in Europe give us hope for meaningful progress in the future. Hemispherx is the only company with a late stage drug candidate for ME/CFS therapy in the U.S.”
“The compassion and attention that Dr. Charles Lapp and his team pay to each patient is special,” said Rodino. “They clearly care about the individual as a whole, not just the health of the patient. They are not just treating the illness, but are helping to improve lives.”
Since the company has been able to expand the Ampligen treatment protocol, additional patients have been enrolled into the program at the North Carolina site.
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
A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/2b6bec42-928f-4941-99d9-1f4b86483531