First shipment of Ampligen for sale to Early Access Program in Europe

US drugmaker Hemispherx Biopharma (NYSE MKT: HEB) says that an order of newly-manufactured rintatolimod (Ampligen) for sale utilizing the Early Access Program (EAP) in Europe has been shipped with receipt confirmed on January 26.

In May 2016, the company executed an amended and restated agreement with Impatients, a Netherland EAP in all of Europe and Turkey. Ampligen is the trade name in the USA for rintatolimod.

“This new lot of rintatolimod (Ampligen) will enable chronic fatigue syndrome (CFS) and pancreatic cancer patients in the European Union and Turkey, to access rintatolimod under early access regulations,”said Tom Equels, chief executive of Hemispherx, adding: “The shipment of new product that has been recently released for use in the initiated EAP is an important tangible step in our effort to make our experimental drug Ampligen available to individuals with CFS and pancreatic cancer.”

Rintatolimod is a member of a new class of specifically-configured ribonucleic acid (RNA) compounds targeted as potential treatment of diseases with immunologic defects and/or viral causation. Ampligen received its first regulatory approval anywhere in the world in Argentina last August for the treatment of severe myalgic encephalomyelitis/chronic fatigue syndrome, with that approval seen as a precursor to validation for the product as the Early Access Program (EAP) is launched in Europe, said Hemispherx at the time. It is still under review with the US Food and Drug Administration.