Combined Highly Active Anti-Retroviral Microbicides (CHAARM) is a large scale collaborative project co-funded by the European Union under the 7th Framework Programme (FP7) for Research and Technological Development. CHAARM is a consortium of 31 partners from academic institutions, research organizations, small and medium enterprises, and larger industries, representing 9 different countries in Europe including Ukraine, as well as South Africa and the U.S. The project will run for 5 years beginning in January 2010 and ending in December 2014 and the project coordinator is King’s College, London.
Pharmaceutical partners include Janssen Pharmaceutical Companies of Johnson & Johnson and Gilead. Janssen is providing darunavir, a protease inhibitor, to the consortium for evaluation as a potential microbicide in combination with dapivirine, another Janssen molecule. Janssen has provided additional resources to develop a formulation and to procure GMP material containing both ARVs for a phase I clinical study. By combining two antiretrovirals with different mechanisms of action, the team hopes to overcome possible resistance issues. The choice of the combination has also been validated in a selection algorithm containing in vitro studies and animal studies.
Given the complexity and the high risk path for developing a new preventative tool in the fight against HIV/AIDS, it is difficult for pharmaceutical companies to fully engage. This collaborative project—which allows academia and pharmaceutical companies to join forces and the public sector to provide some funding—enables pharmaceutical companies to contribute to developing new HIV prevention tools because risks and liabilities are shared.
Both a gel and a ring containing dapivirine and darunavir are available for testing in animals and in humans. A safety and pharmacokinetic study in macaque with both products has been done and an in-vivo challenge study in macaques is planned for 2014.
A first in human safety and pharmacokinetic study is planned with a vaginal gel containing dapivirine and darunavir for the second half of 2014.
|Location||Southern Africa, Cape Verde, Zimbabwe, Zambia, Uganda, Togo, West Africa, Tanzania, Swaziland, Sudan, Burkina Faso, Southern Sudan, South Africa, Somalia, Sierra Leone, Seychelles, Senegal, Sao Tome and Principe, Cote d Ivoire, Rwanda, Nigeria, Niger, Gabon, Mozambique, Mauritius, Mauritania, Guinea-Bissau, Mali, Malawi, Madagascar, Liberia, Lesotho, Kenya, Guinea, Ghana, Gambia, Ethiopia, Eritrea, Equatorial Guinea, Congo, The Republic of, Congo, The Democratic Republic of, Comoros, Chad, Central African Republic, Cameroon, Botswana, Benin, Angola|
|Value||EUR 17 Million|