High Purity Amphotericin B: A Safer Antimycotic in AIDS

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DESCRIPTION (provided by applicant): Cumberland Pharmaceuticals and the University of Mississippi Mycotic Research Centers' long-term goal will be to improve anti-fungal pharmacotherapy particularly for patients with human immunodeficiency infections (HIV). We are jointly developing a high purity amphotericin B (AmB HP) product for intravenous administration. The nominal purity of AmB HP is 95%; excluding surfactant and buffer that are required for formulation. Although in some cases the increase in purity in comparison to current commercial preparations of AmB is modest, preliminary data from our laboratories indicate that removal of contaminating materials markedly decreases the toxicity to AmB without compromising its antifungal efficacy. Thus, AmB HP promises to be a significant addition to current antifungal therapy by offering a preparation with a higher therapeutic index than is offered by current AmB formulations. In the Phase II of this project we will address the production of AmBHP and filing of an NDA for initiating a clinical trial. The clinical trial results will be used to support an NDA for seeking approval for the use of AmB HP in disseminated mycoses commonly seen in patients with HIV infections or other infections of immunocompromised patients.