Bill & Melinda Gates Foundation Announces $25 Million Grant to CONRAD Program's Consortium for Industrial Collaboration in Contraceptive Research
Gift will expand development, testing of microbicides to protect women against AIDS, other STDs
Dr. Henry Gabelnick
SEATTLE -- The Bill & Melinda Gates Foundation today announced a $25 million grant to the CONRAD Program's Consortium for Industrial Collaboration in Contraceptive Research (CICCR) to be used to expand and accelerate development and clinical testing of new non-irritating microbicides to protect women against sexually-transmitted diseases, including AIDS.
"It is clear from the horrendous toll that AIDS is taking on many parts of the world such as sub-Saharan Africa and Asia, that additional preventative measures to condoms are mandatory," said Dr. Gordon Perkin, Executive Director, Global Health for the Bill & Melinda Gates Foundation. "We are pleased to support CONRAD's vital, ongoing work in this area."
The prototypes for the development of microbicides are the currently marketed vaginal spermicidal products which prevent fertility by inactivating sperm. Because nonoxynol-9 (N-9), the active ingredient in most spermicides, kills human immunodeficiency virus (HIV), it was hoped that these preparations would also prevent the transmission of HIV to women. However, several studies have shown N-9 to be ineffective in preventing the transmission of HIV. In fact, the most recent study by UNAIDS reported this week at the International AIDS Meeting in Durban, South Africa, that frequent use of an N-9 containing product (Advantage-S) actually increases the incidence of HIV transmission compared to a placebo, probably due to its irritation of the vaginal lining.
Given the failure of products containing N-9 to protect women against sexually-transmitted diseases and now the likelihood that it might, under certain circumstances, increase susceptibility to HIV, the need to develop new non-irritating women-controlled vaginal products becomes even more urgent. Such new preparations need to be inexpensive, have a long duration of action and be in formulations acceptable to women.
CONRAD/CICCR has had an active program in this area for over a decade, and in conjunction with various industrial partners and academic researchers, has been developing a number of leads including certain high molecular weight polymers, which fit the above criteria. However, progress has been hampered by the lack of sufficient funds to proceed rapidly with the necessary preclinical formulation and safety studies.
"This substantial infusion of funds by the Bill & Melinda Gates Foundation comes at a critical time and will certainly go a long way to relieving some of the current bottlenecks," said Dr. Michael J. K. Harper, CICCR Director.
CONRAD/CICCR plans to collaborate with the World Health Organization and Family Health International to conduct the relevant clinical trials. The funding provided by this generous award will permit these plans to be put into practice immediately and allow development of several lead compounds concurrently, greatly accelerating the development process. It should be noted, however, that the development of new drug products is a time consuming and extremely expensive endeavor. It is hoped that the U.S. Government, the European Union and other private foundations will join in this effort to rapidly expand the evaluation and availability of these potentially life saving products.
Immediate plans are to proceed with the above-mentioned polymers that show good inhibitory activity against a wide range of pathogens in vitro, including HIV, herpes, papilloma virus, gonococcus and chlamydia. Initial clinical safety tests have shown that these polymers do not irritate the vaginal mucosa when used daily. The most urgent need is now to conduct the required toxicology and clinical studies to test for their efficacy in vivo, since this will provide validation of the predictive value of the in vitro tests. This will in turn accelerate preclinical testing of other potential leads, which are at an earlier stage of development.
CONRAD, which was established in 1986 with funding from USAID, is a program of the Eastern Virginia Medical School and is directed by Dr. Henry L. Gabelnick, Professor of Obstetrics and Gynecology. CICCR, which was established in 1995 with funding from philanthropic foundations, is a project of CONRAD and is directed by Dr. Michael J. K. Harper, Professor of Obstetrics and Gynecology.