Hemispherx Biopharma Announces Advancement in Expanded Access Program for Ampligen

Hemispherx Biopharma (NYSE:HEB), an immuno-pharma R&D and emerging commercial growth company focused on unmet medical needs in immunology, shipped 325 recently manufactured vials of Ampligen to the Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) clinical site at Incline Village, Nevada, run by Daniel Peterson, MD.

As quoted in the press release:

This clinic is at the forefront of ME/CFS research and treatment. The vials will be used in the Expanded Access Program (“EAP”) known as “AMP-511”. The FDA authorized the AMP-511 protocol to treat ME/CFS patients in an effort to expand compassionate care in the fight against this quality-of-life impacting disease where there is no commercially approved therapy.

Hemispherx recently announced the expansion of the protocol. New enrollees will not be eligible to participate in a future confirmatory trial. A plan for a future pivotal confirmatory trial is in development, but previously-treated patients will not be eligible for participation. This renders the EAP an increasingly important tool for patients who benefited from Ampligen based on their inclusion in previous trials.

Hemispherx manufactures Ampligen, and it is the Company’s control over the production of the product that allows for use of the product in this EAP.  In 2018, the Company produced two large lots, totaling approximately 16,000 vials, replenishing Ampligen supplies.

Click here to read the full press release.