A single unobtrusive product capable of protecting women against both disease and pregnancy should gain widespread acceptance. BIOTEK is investigating a new vaginal gel, which deactivates pathogens by low pH buffering. Phase I developed and studied vaginal gels containing 2 mg/ml of nonoxynol-9 along with a soluble buffer salt capable of holding the pH between 2 and 3. Studies included in vitro measurements of viscosity, viscous stability, equilibrium pH, buffer capacity, spermicidal activity, in vivo investigation of vaginal pH in sheep, vaginal irritation in rabbits, and microbiological tests on both harmless and pathogenic organisms. The gel appears to inactivate sperm, bacteria and HIV-1 virus. Phase I concluded with a successful effort to reduce rabbit vaginal irritation by replacing the thickening agent. Phase II will revise the Phase I formulation to eliminate nonoxynol-9, confirm the performance of the final formulation, prepare and fully characterize GMP gel, conduct an in vivo study in rabbits and prepare an IND for submission to the FDA shortly before a first human clinical study of this new vaginal product.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
2R44HD038161-02A2
Application #
6776210
Study Section
Special Emphasis Panel (ZRG1-SSS-T (10))
Program Officer
Kaufman, Steven
Project Start
1999-07-01
Project End
2006-07-31
Budget Start
2004-08-01
Budget End
2005-07-31
Support Year
2
Fiscal Year
2004
Total Cost
$289,011
Indirect Cost
Name
Biotek, Inc.
Department
Type
DUNS #
021011499
City
Woburn
State
MA
Country
United States
Zip Code
01801