Hemispherx Biopharma, Inc. announced that the Food and Drug Administration (FDA) has lifted a clinical hold on its Phase II, double-blind, adaptive-design, randomized, placebo-controlled, dose-ranging study of Alferon LDO [oral interferon alfa-n3 (human leukocyte derived)] for the prevention and treatment of influenza. The FDA noted that they had completed the review of a submission dated November 12, 2010 which provided a Complete Response to the Agency’s reasons for continuing this study on clinical hold. In previous 10-K and the recent 10-Qs, Hemispherx provided background information on the clinical hold items.
Dr. William A. Carter, Chairman and Chief Executive Officer, stated, “We are very pleased to have resolved these issues with the FDA and now turn our focus to how best to move this program forward with possible clinical studies in the U.S. and in other parts of the world.” Oral administration of Alferon LDO, an experimental therapeutic, with its anticipated affordability, ease of administration, and broad range of potential bioactivity, could be a breakthrough treatment or preventative for viral diseases.
Date: January 5, 2010
Source: Hemispherx Biopharma, Inc.
Filed Under: Drug Discovery