California, U.S.A. – A new grant from the National Institute of Allergy and Infectious Diseases (NIAID) will support the development of a topical microbicide gel for drug delivery. The innovative gel formulation will be a combination therapy against human immunodeficiency virus (HIV) and herpes simplex virus type 2 (HSV-2) infections in women.
Every day, more than 3,000 women around the world are newly infected with HIV, and it is the leading cause of death in sub-Saharan Africa. Of the 33.3 million people living with HIV/AIDS across the world, 22.5 million are in Africa. HSV-2 is a global epidemic and affects up to 80 percent of the female population in Africa.
As part of the grant, SRI International researchers will develop and test a prototype bioadhesive formulation for sustained delivery of the antiviral drugs tenofovir and acyclovir to the vaginal surface. Because chronic HSV-2 infections have been shown to speed the progression of immunodeficiency disease, researchers are focused on developing a microbicide that prevents both HIV and HSV-2 infections.
“The inexpensive and easy-to-use combination therapy in development could help contain the spread of HIV and HSV, and possibly other sexually transmitted diseases,” said Gita Shankar, Ph.D., director of Formulations R&D, SRI Biosciences. “One of the strongest benefits of a topical gel formula is that it can offer protection when options such as condoms are unavailable or unacceptable.”
The awarded grant is for two years with a possible extension of three additional years. Development work will focus on creating a combination therapy that will limit the risk of drug resistance, while providing women with safe and sustained drug delivery. The novel product will be based on a patented bioadhesive polymeric platform developed at SRI.
SRI’s Biosciences division carries out basic research, drug discovery, and drug development, and provides contract (CRO) services. SRI has all of the resources necessary to take R&D from “Idea to IND” — from initial discovery to the start of human clinical trials—and specializes in cancer, immunology and inflammation, infectious disease, and neuroscience.