Ampligen supply will support product launch in Argentina, Expanded Access Programs for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome in the United States and Europe and pancreatic cancer in the Netherlands, and upcoming U.S. based Phase I/II combination therapy clinical trials in various solid tumors
ORLANDO, Fla., Sept. 18, 2018 (GLOBE NEWSWIRE) — Hemispherx Biopharma, Inc. (NYSE American: HEB) announced today regulatory inspection and clearance for distribution of the Company’s second commercial scale lot of Ampligen® (rintatolimod), which is slated for multiple uses including product launch in Argentina, where Ampligen is approved for the treatment of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), ME/CFS expanded access program (EAP) in the United States and Europe and an EAP in the Netherlands for pancreatic cancer. This lot includes approximately 8,000 vials and is the second such lot filled and finished this year, giving a usable Ampligen supply of approximately 16,000 vials.
Ampligen, a first-in-class drug of large macromolecular RNA (ribonucleic acid) molecules, was approved for commercial sale in Argentina in 2016 for the treatment of ME/CFS, the first therapy ever approved for this quality-of-life impacting disease. The Argentine commercial launch is scheduled for year end and the first quarter of 2019. The Company will also provide Ampligen to medical centers in the U.S. and Europe for use in EAPs for patients with ME/CFS and in the Netherlands for pancreatic cancer. Finally, but significantly, the Company expects to commence additional clinical trials using Ampligen in combination with FDA-approved checkpoint blockade therapies in an effort to improve overall efficacy and survival in cancers such as pancreatic, non-small cell lung, ovarian and colorectal tumors, the first of which may commence within sixty days.
According to the Centers for Disease Control and Prevention, ME/CFS is a serious, long-term illness that affects many body systems. People with ME/CFS are often not able to do their usual activities. At times, ME/CFS may confine them to bed. People with ME/CFS have severe fatigue and sleep problems. ME/CFS may get worse after people with the illness try to do as much as they want or need to do. This symptom is known as post-exertional malaise (PEM). Other symptoms can include problems with thinking and concentrating, pain, and dizziness. According to an Institute of Medicine (IOM) report published in 2015, an estimated 836,000 to 2.5 million Americans suffer from ME/CFS, but most of them have not been diagnosed.
“We are pleased to announce completion of our second commercial size lot of Ampligen and excited about the opportunities availability of the therapy affords us. From a product launch in Argentina, to supporting patients through EAPs and in evaluation for the treatment of solid tumors, we are working to advance Ampligen as rapidly as possible, and realize its potential across multiple market opportunities,” said Thomas K. Equels, Chief Executive Officer of Hemispherx. “While there are millions of ME/CFS patients across the globe, the approval of Ampligen in Argentina represents the first therapy ever approved for treatment of the condition. Additionally, we are hopeful that our initial trials in solid tumor indications will demonstrate the promise of the therapy in combination with checkpoint inhibitors and have a true impact on the cancer treatment paradigm.”
Hemispherx is working to evaluate Ampligen in several cancers, and the current supply of newly filled and finished Ampligen will support the initiation of a Phase I/II study in combination with checkpoint inhibitors in the treatment of solid tumors. The Company is working closely with the internationally acclaimed cancer research centers at Roswell Park, University of Nebraska, and University of Pittsburg to launch these important programs. These planned and imminent clinical trials are based upon pre-clinical animal experiments in which potentially significant combinational synergies were observed. Proof of concept clinical trials have also been conducted in humans to confirm the changes Ampligen creates in the micro-environment of many solid tumors, which are a potential key to improving checkpoint blockade therapy efficacy.
The planned oncology clinical programs follow the recent publication (Cancer Res May 31 2018 DOI: 10.1158/0008-5472.CAN-17-3985) of a head-to-head study in explant culture models that pitted Ampligen against two other TLR3 agonists to measure how each individually might enhance the tumor microenvironment for checkpoint blockade therapy. All three TLR3 agonists activated the TLR3 pathway and promoted an accumulation of killer T cells, but only Ampligen did so without causing attraction of immune suppressive elements, such as regulator T cells. This is a potentially important advantage Ampligen may have over other TLR3 agonists. Additionally, Ampligen is the only TLR3 agonist with an extensive safety profile showing it to be generally well tolerated in humans. Almost 100,000 doses of intravenous Ampligen have been administered in clinical settings.
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.
LHA Investor Relations
Miriam Weber Miller