Pharmaceutical

Hemispherx Biopharma (NYSE: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 …

Hemispherx Biopharma (NYSE: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.

As quoted in the press release:

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.

Click here to read the full press release.

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