ORLANDO, Fla., Aug. 28, 2018 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE American: HEB) announced today that the new Ampligen batch manufactured earlier this year is now released for patients' use in the pancreatic cancer Early Access Program (EAP) in the Netherlands pursuant to the terms of our agreement with our EAP provider. This is the initial shipment (500 vials) of a previously announced 2,100 vial standing stock order issued by myTomorrows, our EAP provider in Europe (https://globenewswire.com/news-release/2016/05/23/842404/0/en/Hemispherx-Amends-and-Restates-Agreement-with-myTomorrows-for-the-Early-Access-Program-for-Rintatolimod-in-Europe.html; https://www.sec.gov/Archives/edgar/data/946644/000149315218004291/form10-k.htm).
Early Access Programs, also known as Expanded Access Programs, are market-specific regulatory programs whereby certain governments allow companies to make a drug available with reimbursement approved before it is officially commercialized for serious or life-threatening diseases outside of a clinical trial — if certain criteria are met — with potential benefits both for patients and for drug development. These government approved programs allow us to supply investigational drugs, while obtaining compensation through reimbursement.
“We have now manufactured approximately 16,000 vials of Ampligen, with 8,000 vials tested and released for our various clinical and early access programs and the remaining vials are expected to be released in the near future. This begins the next logical step in our short term business plan, where we seek to obtain reimbursement, at pre-approved rates, for those vials by supplying early access programs in the United States for ME/CFS and in the Netherlands for pancreatic cancer, as well as the initiation of commercial sales from the second lot as a result of our unrestricted commercial approval for severe ME/CFS in Argentina,” says Thomas K. Equels, chief executive officer at Hemispherx. “We will update you on our progress in expanding the U.S. based AMP-511 FDA approved open label program for severe ME/CFS in the near future as we obtain clear projections on the number of patients who will benefit from this access, who are enrolled and expected to be enrolled at the approved clinical sites. We are also working to expand our ME/CFS U.S. clinical program to unserved regions so as to allow easier access to the AMP-511 program.”
Hemispherx is an immuno-pharma R&D and an emerging commercial development company focused on unmet medical needs in immunology, with a special emphasis in immuno-oncology. Ampligen is currently used in the Netherlands EAP in the treatment of pancreatic cancer. In addition, Ampligen is being assessed by Hemispherx in conjunction with major U.S. cancer research centers for use in combination with checkpoint blockade therapies in a variety of solid tumors, including pancreatic cancer.
In clinical trials in a variety of indications, approximately 100,000 doses of our experimental drug Ampligen have been administered intravenously (IV). We believe this is the most comprehensive IV safety profile that is generally well-tolerated of any systemic TLR agonist. Toll-like receptors (TLRs) are a class of proteins that play a key role in activating the innate immune system and it is believed that they will play an important role in future combination therapies in immuno-oncology. A safety profile of Ampligen administered intranasally also shows it to be generally well-tolerated based on a Phase I/II vaccine study (Overton ET, et al. Intranasal seasonal influenza vaccine and a TLR-3 agonist, rintatolimod, induced cross-reactive IgA antibody formation against avian H5N1 and H7N9 influenza HA in humans. Vaccine.2014;32(42):5490-5.doi: 10.1016/j.vaccine.2014.07.078).
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 Alferon N Injection® and the experimental therapeutic rintatolimod (tradenames Ampligen® or Rintamod®). Rintatolimod is an experimental RNA nucleic acid being developed for globally important debilitating diseases and disorders of the immune system, including immuno-oncology and Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS). Hemispherx’s platform technology includes components for potential treatment of various severely debilitating and life-threatening diseases. Because rintatolimod is experimental in nature, it is not designated safe and effective by the FDA for general use and is legally available only through clinical trials.
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.
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