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news.The US Food and Drug Administration has lifted hold from Hemispherx Biopharma's double-blind, adaptive-design, placebo-controlled, dose-ranging Phase II study evaluating Alferon LDO [oral interferon alfa-n3 (human leukocyte derived)] as a treatment and prevention for influenza.
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Prior to its decision, FDA has completed the review of a submission dated 12 November 2010 which provided a Complete Response to the Agency’s reasons for continuing this study on clinical hold.
Hemispherx chairman and CEO William Carter said that they are pleased to have resolved these issues with the FDA and now turn their focus to how best to move this program forward with possible clinical studies in the US and in other parts of the world.
"Oral administration of Alferon LDO, an experimental therapeutic, with its anticipated affordability, ease of administration, and range of potential bioactivity, could be a breakthrough treatment or preventative for viral diseases," Carter said.