Local delivery of antibodies to the reproductive tract can block sperm and sexually transmitted pathogens to prevent pregnancy or infection. Recent advances in monoclonal antibody technology make it possible to produce large quantities of inexpensive antibodies. This design directed proposal will develop and test formulations for topical antibody delivery to the vagina. We will examine unique vaginal formulations that provide a range of the duration of protection; an immediate acting formulation, a slower acting solid dosage form, and a controlled release vaginal ring that lasts for up to one month will be investigated. Product concepts will be evaluated for efficacy in an animal model of HSV vaginal transmission.

Proposed Commercial Applications

There is a significant market in the U.S. (>$600 million) and the world (>$1.5 billion) for a safe and effective microbicide that prevent STDs. Successful commercialization of vaginal microbicides could save the U.S. a significant amount of the $17 billion spent annually on medical costs for the treatment of STDs.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
5R43AI049030-02
Application #
6511427
Study Section
Special Emphasis Panel (ZRG1-SSS-K (01))
Program Officer
Savarese, Barbara M
Project Start
2001-09-15
Project End
2003-12-31
Budget Start
2002-09-01
Budget End
2003-12-31
Support Year
2
Fiscal Year
2002
Total Cost
$122,625
Indirect Cost
Name
Epicyte Pharmaceutical, Inc.
Department
Type
DUNS #
City
San Diego
State
CA
Country
United States
Zip Code
92121