Non-Toxic Gel to Treat Vulvovaginal Candidiasis

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$110,322.00
Award Year:
2006
Program:
SBIR
Phase:
Phase I
Contract:
1R43AI068375-01
Award Id:
80778
Agency Tracking Number:
AI068375
Solicitation Year:
n/a
Solicitation Topic Code:
n/a
Solicitation Number:
n/a
Small Business Information
BIOMEDICAL DEVELOPMENT CORP, 500 SANDAU, STE 200, SAN ANTONIO, TX, 78216
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
n/a
Principal Investigator:
CHARLES GAUNTT
(210) 308-0636
GAUNTT@BIODEVCORP.COM
Business Contact:
GREGG SIEGEL
(210) 308-0636
GSIEGEL@BIODEVCORP.COM
Research Institution:
n/a
Abstract
DESCRIPTION (provided by applicant): The goal of this project is to develop a safe biocidal vaginal gel for treatment of vulvovaginal candidiasis (WC). WC is caused by one of several airborne species of the yeast Candida that are normal inhabitants of humans at several sites, including the vagina. C. albicans has been associated with causing WC in the past, but drug-resistant non-C. albicans spp. are increasingly being identified as the cause of WC. Many of: he non-C. albicans strains are resistant to normal levels of antifungal drugs. As a result, recurrent WC has become an increasingly common and chronic problem, with patients becoming refractory to treatment due to imitations in available therapy. Biomedical Development Corporation (BDC) is evaluating lova gel as a novel, safe, and effective microbicide. lova gel is a broad-spectrum biocide with activity against viruses, bacteria, and yeast, without nducing resistant mutants or allergenicity. The goal of this project is to develop lova vaginal gel as a treatment for vulvovaginal candidiasis. BDC will execute the following specific aims: Specific Aim 1: Formulate lova Gel Formulations for Use in Treating Vulvovaginal Candidiasis Specific Aim 2: Demonstrate Safety of lova Gel Formulations Specific Aim 3: Demonstrate Effectiveness of lova Gel Formulations in Killing Planktonic Candida spp. Specific Aim 4: Demonstrate that lova Gel is Effective in Eradicating a Persistent Candida albicans Vaginal Infection in Rats , Relevance to Public Health: Vaginitis is the most common gynecologic diagnosis in primary care globally, affecting an estimated 1 billion women each year. WC accounts for 30-45% of vaginitis, and approximately 75% of premenopausal women will have at least one episode of WC. Among premenopausal women, 70- 75% will have at least one episode of WC and half of all college women will, by age 25, have had one episode of WC diagnosed by a physician. Annual costs for treating WC in the U.S. are estimated at $1.8 billion.

* information listed above is at the time of submission.

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