High Purity Amphotericin B: A Safer Antimycotic in AIDS

Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: 1R41AI063935-01A1
Agency Tracking Number: AI063935
Amount: $110,644.00
Phase: Phase I
Program: STTR
Awards Year: 2005
Solitcitation Year: N/A
Solitcitation Topic Code: N/A
Solitcitation Number: N/A
Small Business Information
Cumberland Pharmaceuticals, Inc.
Cumberland Pharmaceuticals, Inc., 2525 West End Ave, Ste 950, Nashville, TN, 37203
Duns: N/A
Hubzone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 JOHN CLEARY
 (601) 984-2639
 JCLEARY@MEDICINE.UMSMED.EDU
Business Contact
  LEO PAVLIV
Phone: (615) 255-0068
Email: AKAZIMI@CUMBERLANDPHARMA.COM
Research Institution
 UNIVERSITY OF MISSISSIPPI
 125 OLD CHEMISTRY
P.O. BOX 907
UNIVERSITY, MS, 38677
 Nonprofit college or university
Abstract
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.

* information listed above is at the time of submission.

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