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Treatment and/or Prevention of Urinary Tract Infections

Award Information

Agency:
Department of Health and Human Services
Branch:
N/A
Award ID:
89517
Program Year/Program:
2008 / STTR
Agency Tracking Number:
DK082089
Solicitation Year:
N/A
Solicitation Topic Code:
N/A
Solicitation Number:
N/A
Small Business Information
BIOMEDICAL DEVELOPMENT CORPORATION
A152 ASTeCC Building Lexington, KY 40506-
View profile »
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No
 
Phase 1
Fiscal Year: 2008
Title: Treatment and/or Prevention of Urinary Tract Infections
Agency: HHS
Contract: 1R41DK082089-01
Award Amount: $226,733.00
 

Abstract:

DESCRIPTION (provided by applicant): Urinary tract infections (UTIs) are very common bacterial infections that affect millions of people each year. In the U.S., approximately 10% of women are diagnosed with cystitis annually, with an associated cost of 1. 6 billion. UTIs are also the most commonly occurring nosocomial infection, and nosocomial UTIs mostly arise as a consequence of indwelling urinary catheters. Although UTIs are generally effectively treated with antibiotic therapy, the emergence of resistan ce among uropathogens is becoming more common and has developed into one of the most important factors impacting the management of UTIs. The goal of this project is to develop a novel product for the treatment and/or prevention of urinary tract infections that is unlikely to induce microbial resistance. The product has been shown to be safe in previous human studies. Phase I studies will focus on completing federal regulatory requirements including manufacturing the product in a quality system and submittin g an Investigational New Drug application to the FDA. Subsequent to the acceptance of the IND by the FDA, the treatment will be tested in a clinical trial of treatment of acute, uncomplicated UTI. The Specific Aims of the proposal are: Aim 1. Complete Regu latory Requirements for an Investigational New Drug Aim 2. Evaluate Efficacy of the Treatment in a Human Clinical Trial of Cystitis PUBLIC HEALTH RELEVANCE Urinary tract infections (UTIs) are the second most common type of human infection and a ffect millions of people each year. UTIs account for about 7.3 million doctor visits annually. An estimated 1 in 3 women will have at least one UTI requiring antimicrobial treatment by the age of 24. During their lifetimes, more than half of all women will have a urinary infection, and these infections are often recurrent. A new therapy to treat and/or prevent UTIs is needed due to increased microbial resistance to current antibiotic treatments. An agent to prevent and treat UTI that does not encourage micr obial resistance would have a significant impact on public health.

Principal Investigator:

Business Contact:


gsiegel@biodevcorp.com
Small Business Information at Submission:

BIOMEDICAL DEVELOPMENT CORPORATION
BIOMEDICAL DEVELOPMENT CORP 500 SANDAU, STE 200 SAN ANTONIO, TX 78216

EIN/Tax ID: 742330067
DUNS: N/A
Number of Employees: N/A
Woman-Owned: No
Minority-Owned: No
HUBZone-Owned: No