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AIDS Therapies

FDA Authorizes Protocol in Multi-Drug Resistant Disease

Published in AIDS Weekly, September 18th, 2000

Hemispherx Biopharma, Inc. (HEB; HEBws), Philadelphia, Pennsylvania, has received U.S. Food and Drug Administration (FDA) authorization to conduct an advanced multi-center clinical study in drug-resistant HIV.

The clinical study will involve 100 patients residing in the continental United States. Candidate patients exhibit multi-drug resistance to other antivirals, which have previously received full marketing authorization and are already in general use.

The Hemispherx protocol is designed to potentially treat multi-drug resistance, which is due to numerous HIV genomic mutations, or genetic rearrangements. The mutations eliminate the standard...

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