ORLANDO - Hemispherx Biopharma, Inc. (NYSE American: HEB) has announced the immediate expansion of its Treatment Protocol/Expanded Access Programs for ME/CFS in the United States, known as AMP-511, to new enrollees for the first time in more than a year.
This opportunity to expand the scope of AMP-511 is based on the successful completion of the first phase of its Ampligen manufacturing initiative producing sufficient quantities of Ampligen to support new enrollees in this FDA-approved program. Additional enrollees will be added as supplies of Ampligen expand with the successful fill and finish of additional commercial-sized lots similar to the 8,500 vials just released for human use. However, due to the nature of the limitations in such FDA-approved programs, the number of enrollees will always be limited.
The two approved sites are the Hunter-Hopkins Center in Charlotte, North Carolina and Sierra Internal Medicine in Incline Village, Nevada.
Charles W. Lapp, MD, Principal Investigator at Hunter-Hopkins Center stated 'Hunter-Hopkins Center is delighted to hear that the compassionate care program for Ampligen/rintatolimod will once again be welcoming new subjects.'
Daniel Peterson, MD, Principal Investigator at Sierra Internal Medicine stated 'We are very enthusiastic about the recent communication from Hemispherx Biopharma announcing the immediate compassionate care protocol expansion.'
Hemispherx announced on June 3, 2018, that its first commercial sized lot of Ampligen, consisting of 8,500 vials, had passed all required testing for regulatory release for human use. 'We view the compassionate care program as just a band aid for a much larger problem. We estimate over one hundred thousand people are now fully disabled in the United States due to ME/CFS. This incapacitating unmet medical need should be aggressively addressed by providing therapeutic options, just as the FDA did when it successfully addressed the AIDS crisis years ago,' said Thomas K. Equels, Chief Executive Officer of Hemispherx. 'This successfully released batch of Ampligen will be utilized to expand our ME/CFS compassionate care programs in Nevada and North Carolina and our expanded Early Access Program in Europe in pancreatic cancer, as well as for important immuno-oncology clinical studies in the United States. These studies will include Phase I/II studies of Ampligen in combination with checkpoint blockade drugs in a variety of solid tumor cancers.'
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an immuno-pharma R&D and emerging commercial growth company focused on unmet medical needs in immunology. Hemispherx's flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen or Rintamod) and the FDA-approved drug Alferon N Injection. Based on results of published, peer reviewed pre-clinical studies and clinical trials, Hemispherx believe that Ampligen may have broad-spectrum anti-viral and anti-cancer properties. Clinical trials of Ampligen already conducted by Hemispherx include studies of the potential treatment of cancer patients with renal cell carcinoma and malignant melanoma, CFS, Hepatitis B and HIV. All of these potential uses will require additional clinical trials to generate the safety and effectiveness data necessary to support regulatory approval. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and disorders of the immune system. Commercialization of Ampligen in Argentina will require, among other things, an appropriate reimbursement level, appropriate marketing strategies, completion of manufacturing preparations for launch (including possible requirements for approval of final manufacturing) and we most likely will need additional funds to manufacture product at a sufficient level for a commercial launch.
Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. 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.