Hemispherx Biopharma (NYSE
American:HEB) said, its Contract Manufacturing Organization (CMO) for
Ampligen® has completed a commercial scale demonstration/engineering
manufacturing run, along with the re-qualifications of analytical
methods that were agreed upon during a previous successful Pre-Approval
Inspection (PAI) as necessary prior to the production of commercial lots
of Ampligen®.
- Ampligen®
has been approved in Argentina for severely debilitated Myalgic
Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) patients. Hemispherx
recently reported that discussions are underway with the U.S. FDA on
the next steps regarding a New Drug Application (NDA) for Ampligen® in
ME/CFS, which afflicts more than one million people in this country,
according to the Centers for Disease Control (CDC). Ampligen® is the
only drug to have completed a Phase 3 clinical trial in the U.S. in
ME/CFS.
- Earlier this year Hemispherx began supplying Ampligen® for pancreatic cancer patients in an Early Access Program (EAP) in the Netherlands. In addition, work is underway at two leading U.S. cancer centers to define Ampligen®’s potential role in enhancing the effectiveness of PD-1 and PD-L1 checkpoint inhibitors in the fast-growing field of immuno-oncology.
About Hemispherx Biopharma, Inc.
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the clinical development of new drug entities for treatment of seriously debilitating disorders. 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 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.
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