The CONRAD Program of the Eastern Virginia Medical School obtained a $100 million award from the U.S. Agency for International Development (USAID) for further development of microbicides. This backing comes on top of $60 million previously given to the program.
“This cooperative agreement will support five years of research for a variety of studies that will advance progress toward a successful microbicide with a focus on continued clinical testing of several microbicide candidates in trials including tenofovir gel, which is currently in a Phase IIb trial in South Africa, and UC781, which is currently undergoing safety studies at several sites here and abroad,” says Henry Gabelnick, executive director of CONRAD.
Data from the Phase IIb study of Tenofovir, which is being done in collaboration with CAPRISA, is expected by the end of 2009, according to Gabelnick. If results are good, the organizations could file for early registration, he notes. Gabelnick does point out that since this is a fairly small trial, a larger study will likely be needed before final approval.
With UC781, Gabelnick says that an expanded Phase II study will begin in 2009, with the hope of entering Phase III development in 2010.
CONRAD is also working on identifying biomarkers that can predict the efficacy of a candidate microbicide to enhance patient enrollment in a Phase III trial.