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Oral AmB for the treatment of fungal infection

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: N/A
Agency Tracking Number: 2R44AI046040-02
Amount: $0.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: N/A
Solicitation Number: N/A
Timeline
Solicitation Year: N/A
Award Year: 2001
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
C/O UMDNJ NEW JERSEY MED SCHOOL ADM BLDG 4, 185 S ORANGE AVE
NEWARK, NJ 07103
United States
DUNS: N/A
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 LEILA ZARIF
 () -
Business Contact
Phone: (973) 972-0324
Research Institution
N/A
Abstract

DESCRIPTION (provided by applicant): The long term goals of our research are to
develop new formulations of therapeutically important drugs using cochleates as
the delivery vehicle. Such formulations would have an improved route of
delivery (oral rather than injectable to improve ease of administration and to
reduce adverse effects of parenteral therapy), and lower toxicity, thereby
improving the safety profile of drugs. The SBIR Phase I advanced the
development of a new formulation of amphotericin B (AmB) that has low toxicity
and allows the oral delivery of AmB. Oral amphotericin B cochleates showed
excellent activity in murine models of clinically relevant invasive fungal
infections: Disseminated candidiasis, disseminated aspergillosis, and central
nervous system cryptococcosis. The overall objective of this SBIR Phase II is
to further develop this new AmB cochleate formulation for the following target
indications: 1) Treatment of azole-susceptible and azole-resistant
oropharyngeal and esophageal candidiasis in immunosuppressed patients, 2)
empiric therapy for presumed fungal infection in febrile, neutropenic patients,
3) treatment of selected patients with proven or probable invasive infections
due to Aspergillus species, Candida species, and other life-threatening
invasive fungal infections. To this end the following specific aims will be
investigated:

1. To optimize cochleate AMB formulations (CAMB) as a commercially viable human
therapeutic by testing CAMB prepared with less expensive raw materials (mainly
phosphatidylserine) and simplified protocols.
2. To perform preclinical studies in a higher animal model.
3. To determine the mechanism of drug delivery mediated by cochleate
4. To initiate Phase I trials with CAMB in humans
PROPOSED COMMERCIAL APPLICATION: NOT AVAILABLE

* Information listed above is at the time of submission. *

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